ewg’s 2010 sunscreen guide -...

EWG’s 2010 Sunscreen Guide 1

EWG’s 2010 Sunscreen GuidevThe Bottom Line on Sunscreens Few sunscreens win green rating

EWG’s fourth annual Sunscreen Guide gives low marks to the current crop of sunscreen products, with a few notable exceptions. EWG researchers recommend only 39 – 8 percent – of 500 beach and sport sunscreens for this season.

The reason? A surge in exaggerated SPF claims above 50 and new disclosures about potentially hazardous ingredients, in particular recently developed government data linking the common sunscreen ingredient vitamin A to accelerated development of skin tumors and lesions.

Industry’s lackluster performance and the federal Food and Drug Administration’s failure to issue regulations for sunscreens lead EWG to warn consumers not to depend on any sunscreen for primary protection from the sun’s harmful ultraviolet rays. Hats, clothing and shade are still the most reliable sun protection.

Products with high SPF ratings sell a false sense of security because most people using them stay out in the sun longer, still get burned (which increases risk of skin cancer) and subject their skin to large amounts of UVA radiation, the type of sunlight that does not burn but is believed responsible for considerable skin damage and cancer. High SPF products, which protect against sunburn, often provide very little protection against UVA radiation.

Few people use enough sunscreen to benefit from the SPF protection promised on the label. Studies show that people typically use about a quarter of the recommended amount. Because sunscreen effectiveness drops off precipitously when under-applied, in everyday practice a product labeled SPF 100 actually performs like SPF 3.2, an SPF 30 rating equates to a 2.3 and SPF 15 translates to 2. Moreover, FDA scientists say SPF claims above 50 cannot be reliably substantiated.

This year, new concerns have arisen about a form of vitamin A called retinyl palmitate, found in 41 percent of sunscreens. The FDA is investigating whether this compound may accelerate skin damage and elevate skin cancer risk when applied to skin exposed to sunlight. FDA data suggest that vitamin A may be photocarcinogenic, meaning that in the presence of the sun’s ultraviolet rays, the

| Environmental Working Group2

compound and skin undergo complex biochemical changes resulting in cancer. The evidence against vitamin A is far from conclusive, but as long as it is suspect, EWG recommends that consumers choose vitamin A-free sunscreens.

EWG has again flagged products with oxybenzone, a hormone-disrupting compound which penetrates the skin and enters the bloodstream. Biomonitoring surveys conducted by the Centers for Disease Control have detected oxybenzone in the bodies of 97 percent of Americans tested.

In all, EWG researchers assessed about 1,400 products with SPF, including beach and sports lotions, sprays and creams, moisturizers, make-up and lip balms. The 39 beach and sports products that earned EWG’s coveted “green” rating for safety and efficacy all contain the minerals zinc or titanium. We could find no non-mineral sunscreens that scored better than “yellow.”

Some of the blame falls on the FDA, which has yet to finalize regulations for sunscreens promised since 1978. FDA officials estimate that the regulations may be issued next October – but even then, they expect to give manufacturers at least a year, and possibly longer, to comply with the new rules. That means the first federally regulated sunscreens won’t go on store shelves before the summer of 2012.

Sunscreen and skin cancer – the scienceThe first sunscreens were developed to prevent severe sunburn for military personnel spending long hours under strong and direct sunlight (Maceachern 1964). Today, they are associated with a wide range of purported purposes, from reducing skin aging and direct sun damage to decreasing the risk of skin cancer. Yet expert opinions differ widely on the strength and reliability of scientific evidence that supports these claims (Autier 2009; Draelos 2010).

The power of sunscreen to protect against sunburn is well known; this is the feature of sunscreens identified as the Sun Protection Factor or SPF. Yet, the wide availability of sunscreens has allowed people with light-color skin to stay outdoors longer, often aiming to get a tan or to maximize burn-free time in the sun (Autier 2009; Lautenschlager 2007). Expert’s recommendations to wear sunscreen are tempered. Skin cancer rates continue to increase in the U.S. and other countries. Studies do not provide evidence that sunscreen protects against the deadliest form of skin cancer, and scientists are not certain about which type of UV radiation, UVA or UVB, is most dangerous and therefore most important for sunscreen to block or absorb. Sobering statistics on skin cancer raise basic questions about sunscreen efficacy:

Even though more people use sunscreen than ever before, the incidence of skin cancer in • the United States and other countries continues to rise (Aceituno-Madera 2010; Jemal 2008; Osterlind 1992).


A number of studies conducted in the 1990s report higher, not lower, incidence of the • deadliest form of skin cancer, malignant melanoma, among frequent sunscreen users (Autier 1995; Westerdahl 2000; Wolf 1994). According to the American Cancer Society, malignant melanoma accounts for only 3-4% of all • skin cancer cases, but is responsible for 75% of all deaths attributed to the disease each year (ACS 2010) (See side-bar: “The 3 types of skin cancer”)To date, studies show that regular sunscreen use reduces risk for squamous-cell carcinoma • (SCC) but not other types of skin cancer. SCC, a slow-growing, treatable cancer, is estimated to account for just 16% of all skin cancers annually.

•

The 3 types of skin cancerSkin cancer is the most common cancer in the United States, accounting for nearly half of all cancer cases. One to 2 million people develop skin cancer each year (Bikle 2008; Rogers 2010, ACS 2010). A recent study estimated that the disease is five times more prevalent in the U.S. population than breast or prostate cancers (Stern 2010).

Precise numbers for skin cancer incidence in the U.S. are not known, since non-melanoma skin cancer is usually excluded from cancer registry statistics and, additionally, their incidence varies by the geographical region (Rubin 2005). However, according to a review published by the American Cancer Society, among all the skin cancers 80% are basal-cell carcinoma (BCC), 16% are squamous-cell carcinoma (SCC), and 4% are malignant melanomas, the deadliest form of skin cancer (Greenlee 2001).

Melanoma and sunscreen: UVA, UVB or both?For decades, sunscreens available on the market primarily blocked UVB, the wavelength of ultraviolet radiation that causes sunburns (Draelos 2010). Sunscreen manufacturers and sunscreen users assumed that preventing or delaying sunburn would also protect from other dangerous effects of the sun such as skin cancer.

Today, many experts believe that both UVA and UVB exposure may contribute to melanoma risk (Garland 2003; Godar 2009). Sunscreens produced over the past three decades that blocked UVB but allowed higher UVA exposure may not have been able to provide the necessary cancer protection (Draelos 2010) and may have contributed to risk of melanoma in some populations (Gorham 2007).

Sunlight that reaches the surface of the Earth consists of longer-wavelength UVA (315–400 nm), shorter wavelength UVB (280–315 nm), visible light, and infrared light. UVB constitutes 3-5% of the total UV radiation that gets through the atmosphere, while UVA constitutes 95-97%. UVB, which only penetrates the outer skin layer, is the primary cause of sunburn (erythema or redness)


and non-melanoma skin cancer such as squamous cell carcinoma (von Thaler 2010). In contrast, UVA can penetrate deeper into the skin where it causes a different type of DNA damage than does UVB (Cadet 2009).

Even though many sunscreens now include UVA filters, a large number of products available in 2010 still fail to adequately protect sunscreen users from UVA radiation.

A growing body of data points to UVA exposure as a significant factor in melanoma development. But scientists still do not know the relative importance of UVA and UVB in melanoma development (Donawho 1996; Setlow 1993), a knowledge gap that raises the importance of broad-spectrum protection in sunscreens, with filters that absorb both UVA and UVB radiation:

“Results from animal models, epidemiological studies, and clinical observations suggest that • UVA might play an important role in the pathogenesis of malignant melanoma.” Rünger 1999, Photodermatology, photoimmunology & photomedicine.“Collectively, [current] data suggest a potential role for UVA in the pathogenesis of • melanoma.” Wang et al 2001, Journal of the American Academy of Dermatology.“The issue of [melanoma] action spectrum has been a subject of debate, with some groups • suggesting that the effect of UVA is predominant in human melanoma with earlier groups having suggested that UVB is the predominant cause of skin cancer in general, although not necessarily melanoma in particular.” Garland et al. 2003, Annals of Epidemiology.“Although sunlight is known to cause melanoma, there has been considerable controversy as • to the importance of short (UVB) and long (UVA) ultraviolet (UV) wavelengths in causing melanoma, leading to uncertainty in how best to prevent this cancer. This uncertainty has been compounded by the difficulties in assaying the UVA protection abilities of sunscreens, as compared to widely accepted measures of UVB screening by the sun protection factor (SPF).” Lund & Timmins 2007, Pharmacology and therapeutics.“The [sunscreen’s] ability to prevent sunburns (as measured by SPF) probably does not • imply the ability to prevent melanoma or basal cell carcinoma.” Autier 2009, British Journal of Dermatology.“The specific contribution of UVB and UVA radiation exposure towards the risk of melanoma • is controversial.” von Thaler et al. 2010, Experimental Dermatology.“There is also sufficient evidence of an increased risk of ocular melanoma associated with the • use of tanning devices.” International Agency for Research on Cancer (IARC) 2009. “Indoor tanning facilities in general deliver higher relative intensities and higher proportions of UVA compared with solar UV radiation.” IARC 2006.

Why don’t scientists know more about sunscreen and skin cancer?Three factors preclude drawing definitive conclusions about the effects of sunscreens on skin cancer


risk: 1) in parallel with protection from sunburns, application of sunscreens has been also associated with increased sun exposure, including usually unexposed sites such as the trunk (Autier 2000; Dupuy 2005; Stanton 2004); 2) early-generation sunscreens did not provide significant or adequate UVA protection or possibly even sufficient UVB protection (Diffey 2009; Lautenschlager 2007; Osterwalder 2009); 3) sunscreen use in the populations studied may not have been consistent or sufficient to provide the protection from melanoma (Bech-Thomsen 1992; Thieden 2005).

Published studies have examined the correlation between sunscreen use and the development of the three most common forms of skin cancer: basal cell carcinoma, squamous cell carcinoma, and malignant melanoma. In 2000, International Agency for Research on Cancer (IARC) reviewed available data and concluded that:

Sunscreen use may decrease the occurrence of squamous cell carcinoma.• Sunscreen use has no demonstrated influence on basal cell carcinoma.• In intentional sun exposure situations, sunscreen use may increase the risk of melanoma (IARC • 2001a; reviewed in Autier 2009).

Studies conducted over the past decade have confirmed that regular sunscreen use lowers the risk of squamous cell carcinoma (Gordon 2009; van der Pols 2006), similar to studies completed in the 1990s (Green 1999). Regular sunscreen application also diminishes the incidence of solar keratosis (also known as actinic keratosis), a type of sun-induced skin changes that may become precursors to squamous cell carcinoma (Naylor 1995; Thompson 1993). For basal cell carcinoma, follow up studies reported a slight and not-statistically significant decrease in risk associated with sunscreen use (Pandeya 2005; van der Pols 2006). Thus, for this cancer type, data on sunscreen benefits remain negative or equivocal (Hunter 1990; Rosenstein 1999; Rubin 2005).

However, from the public health perspective, physicians are most concerned about malignant melanoma, the deadliest type of skin cancer (Lund 2007; World Health Organization 2006). Sunburns are an important risk factor for melanoma (Leiter 2008). Intermittent, severe sunburns in childhood have been considered to pose the greatest risk, although sunburn during all life periods likely contributes to melanoma development (Autier 1998; Dennis 2008).

State of the evidence: human epidemiology studies of melanoma risk in sunscreen usersIndividual studies provide conflicting evidence on the role of sunscreen in melanoma risk. Studies in Sweden, Belgium, France, Germany, Austria, and New York state report an elevated risk of melanoma in sunscreen users (Autier 1998; Beitner 1990; Graham 1985; Westerdahl 2000; Wolf 1998). In contrast, studies in Spain, Brazil and San Francisco, California report decreased risk of melanoma in sunscreen users (Bakos 2002; Espinosa Arranz 1999; Holly 1995; Rodenas 1996).

A 2000 IARC assessment of 15 studies on sunscreen and melanoma revealed conflicting evidence


regarding associations between sunscreen and melanoma, with 3 studies showing significantly lower risks on melanoma associated with sunscreen use, 8 studies finding significantly higher risks associated with sunscreen use, and 4 studies reporting no effect (IARC 2001, reviewed in Dennis 2003; Diffey 2009; Gorham 2007; Huncharek 2002).Some scientists have combined the data from multiple sunscreen studies in what are called “meta-analyses,” which allows them to assess larger or specialized groups of sunscreen users. A meta-analysis of melanoma studies conducted by University of Iowa scientists in 2003, reported a lack of overall association between melanoma risk and sunscreen use (Dennis 2003). The Iowa researchers suggested that findings of elevated risk in a large group of studies conducted in Europe and U.S. may have been due to confounding effects, such as differences in skin sensitivity to sunlight among people with lighter or darker skin. Sunscreens are more likely to be used by people most at risk of quick sunburn (Diffey 2009; Geller 2002), a group at higher risk for melanoma (Dubin 1986).

In contrast to the conclusion from the Iowa group, a meta-analysis conducted by University of California San Diego scientists in 2007 found a link between the location of the study (high or low latitude from the equator) and the risk of melanoma in relationship to sunscreen use. According to this analysis, in populations living at latitudes below 40o from the equator, the use of sunscreens was associated with a non-significant decreased risk of melanoma, while populations in higher latitudes faced a statistically significant increase in melanoma risk linked with sunscreen use (Gorham 2007).

Skin pigmentation may have been the reason for these latitude effects (Gorham 2007). Studies finding protective effects of sunscreens generally included Mediterranean populations or populations with prevalent Mediterranean ancestry, which have higher degree of constitutive pigmentation. On the other hand, studies conducted in light-skinned populations residing far from the equator (above 40o latitude) generally found a statistically significant 60 percent increase in melanoma risk (Espinosa Arranz 1999; Rodenas 1996).

Experts generally agree that the tendency of sunscreen users to spend more recreational time in direct sunlight and to wear less protective clothing may increase the amount of sun damage that leads to melanoma (Autier 2009; Draelos 2010; Gorham 2007). Additionally, scientists still do not know which wavelengths of sunlight drive melanoma development (Donawho 1996). Thus, historical absence of broad-spectrum UV protection in sunscreen, especially UVA protection, may have contributed to melanoma development or at least to the lack of evidence for a decrease in melanoma risk (Garland 2003; Godar 2009).

With so little known with confidence about sunscreen and skin cancer, it is no wonder that many experts are now recommending clothing and shade, not sunscreen, as primary barriers from sun exposure.


Health agencies question sunscreen efficacyMost experts agree that people should use sunscreens to protect their skin from the sun, but they disagree widely on how well they actually work.

Studies of frequent sunscreen users have shown reduced risks for squamous cell carcinoma, a slow-growing tumor that is readily treatable by surgery, compared to people who use sunscreen infrequently or not at all. But some research teams have found the opposite for the deadliest form of skin cancer, melanoma, concluding that sunscreen users are at increased risk. No one knows why. Some studies demonstrate that sunscreen users stay out in the sun longer and absorb more radiation overall. Scientists speculate that substances called free radicals, released in skin when sunscreen chemicals break down in sunlight, may also play a role.

One other hunch: Inferior sunscreens with poor UVA protection, which have dominated the market for 30 years, may have driven this surprising outcome.

The conflicting science has divided the experts, with some questioning whether sunscreens do anything to prevent skin cancer of any kind.

Many experts agree on the lack of evidence that sunscreens protect against skin cancer:

* “FDA is not aware of data demonstrating that sunscreen use alone helps prevent skin cancer.” – U.S. Food and Drug Administration (FDA) 2007* “Sunscreens were never developed to prevent skin cancer. In fact, there is no evidence to recommend that sunscreens prevent skin cancer in humans.” — Zoe Diana Draelos, editor of Journal of Cosmetic Dermatology, 2010As a result, there is differing advice on how best to protect oneself from the sun’s damaging radiation:

In defense of shade and clothingThe International Agency for Research on Cancer (IARC) is one of many public health agencies that recommend taking other measures before using sunscreens:

* “Sunscreens should not be the first choice for skin cancer prevention and should not be used as the sole agent for protection against the sun” – IARC 2001

The agency’s experts have noted that people wearing sunscreens may be tempted to stay in the sun longer than is safe. They write: “The use of sunscreens can extend the duration of intentional sun exposure, such as sunbathing. Such an extension may increase the risk for cutaneous melanoma”


(Vainio 2000). The agency advocates wearing protective clothing, seeking shade, timing outdoor play to avoid peak sun – and using sunscreen only then (IARC 2001).

Zoe Diana Draelos, editor of the Journal of Cosmetic Dermatology, has hypothesized that sunscreens may not be as safe as dermatologists contend and should be used only on exposed areas, like the hands, that cannot easily be covered with tightly woven clothing. She notes that wearing clothing “over most of the body, with sunscreen only applied to exposed areas, such as face and hands, might minimize systemic levels and prevent problems, which as of yet are poorly understood” (Draelos 2010). Among these problems is the potential hormonal toxicity of sunscreen active ingredients (Draelos 2010; Janjua 2008; Soto 2005). Whole-body application of sunscreens would increase systemic absorption of these ingredients through the skin and the risk of adverse health effects.

In defense of sunscreenOthers experts have been more outspoken in defense of sunscreens. A recent article in the British Journal of Dermatology suggested that “despite the lack of evidence demonstrating the efficacy of modern sunscreens in preventing melanoma… it would be irresponsible not to encourage their use, along with other sun protection strategies, as a means of combating the year-on-year rise in melanoma incidence” (Diffey 2009). Similarly, the American Academy of Dermatology said in a 2009 statement: “To protect against skin cancer, a comprehensive photo-protective regimen, including the regular use and proper use of a broad-spectrum sunscreen, is recommended.”

In defense of neither sunscreens nor clothingThe National Cancer Institute has concluded that there is no evidence that covering the skin at all, whether with clothing or sunscreens, decreases the risk of skin cancer, a sobering finding: “It is not known if protecting skin from sunlight and other UV radiation decreases the risk of skin cancer. It is not known if non-melanoma skin cancer risk is decreased by staying out of the sun, using sunscreens, or wearing long sleeve shirts, long pants, sun hats and sunglasses when outdoors” (NCI 2009).

In defense of sunlightFinally, many scientists have called attention to the benefits of sunlight and outdoor time to stimulate production of vitamin D, which the skin generates when exposed to sunlight, and to enhance overall well being (Fielding 2010; Lucas 2008). According to scientists at the Los Angeles County Department of Public Health, “avoiding sun exposure by staying indoors more may come at the cost of adequate physical activity. The consequences of overweight and obesity, cardiovascular disease, and, yes, potentially many non-skin types of cancer indicate that there are important trade-offs between messages to reduce sun exposure and messages to get regular sun exposure to


stimulate the production of vitamin D and to get adequate physical exercise.” (Fielding 2010) A range of experts say vitamin D’s benefits should be considered in issuing recommendations for sun protection and sunscreen use (Grant 2009; Reichrath 2009; Tang 2010).

What’s wrong with high SPF?Theoretically, applying SPF 100 sunscreen allows beachgoers to bare their skin to sunshine a hundred times longer before causing the skin to burn: Someone who would normally redden in 30 minutes could remain in the sun for 50 hours before a burn would appear.

But for high-SPF sunscreens, theory and reality are two different things. Studies have found that users of high-SPF sunscreens have similar or even higher exposures to harmful ultraviolet (UV) rays than people relying on lower SPF products. The reason: People trust the product too much, go too long before reapplying it and stay out in the sun too long (Autier 2009).

In 2007, the FDA published draft regulations that would prohibit companies from labeling sunscreens with an SPF (sun protection factor) higher than “SPF 50+.” The agency wrote that higher values would be “inherently misleading,” given that “there is no assurance that the specific values themselves are in fact truthful…” (FDA 2007).

Since then FDA has been flooded with data from sunscreen makers seeking to win agency approval for high-SPF products, and store shelves have been increasingly packed with high-SPF products the agency has yet to validate. Johnson & Johnson (makers of Neutrogena and Aveeno sunscreens) submitted data in August 2008 to support SPF 70 and SPF 85 claims (J&J 2008). Playtex (Banana Boat sunscreen) sent data supporting high SPF claims in 2007. A Coppertone spokeswoman said, “Many manufacturers, including Coppertone, have submitted new data [on high-SPF products] for review and are awaiting FDA’s response” (Boyles 2009).

High-SPF sunscreens are popular. Sales have been on the rise for at least a decade, so it’s no wonder that sunscreen makers are fighting to keep them legal. In a letter to FDA 10 years ago, Neutrogena cited consumers’ clear demand for high SPF products, calling them “one of the fastest growing segments” of the market (Neutrogena 2000). Between 2004 and 2008, sales of high-SPF products in Europe (SPF 40 and 50+) swelled from 15 percent to 20 percent of the market (Jones 2010). In 2010, sunscreen makers have once again increased their high-SPF offerings in the US. Nearly one in six products now lists SPF values higher than “SPF 50+”, compared to only one in eight the year before, according to EWG’s analysis of nearly 500 beach and sport sunscreens.

Here’s what’s wrong with high-SPF sunscreens:

Extended sun exposure, same number of sunburnsUsers of high-SPF sunscreens stay in the sun longer with a single application and get burned when the product’s chemicals break down, wash off or rub off on clothes and towels. Armed with a false sense of security, they extend their time in the sun well past the point when users of low-SPF products head indoors. As a result, they get the same number of sunburns as unprotected sunbathers and absorb more damaging UVA radiation, which many high-SPF products do not effectively block.

People seeking “intentional sun exposure” are most at risk from high-SPF products. In contrast to landscapers, gardeners, baseball players and others who spend defined times outdoors for specific jobs (“nonintentional sun


exposure”), people in the intentional exposure category intend to tan or otherwise expose large areas of bare skin to the sun for prolonged periods (Autier 2009).

Studies of volunteers on summer vacation in France, Switzerland and Belgium found that those using high-SPF products extended their sunbathing time by 19-to-25 percent, used the same amount of sunscreen as those using low-SPF products, were likelier to start sunbathing at noon instead of the later hours chosen by the low-SPF users and got the same number of sunburns. From these studies it appears that by delaying sunburn, high-SPF products take away a key warning of UV overexposure. Sunbathers stay out longer and soak up more radiation, especially in the UVA range where sunscreens are relatively ineffective (Autier 2009).

Philippe Autier, a scientist at the International Agency for Research on Cancer, concluded that high-SPF products spur “profound changes in sun behavior” that may account for the increased melanoma risk found in some studies. He advises that people seeking sun exposure “should be advised not to use sunscreen but rather to let their skin adapt and set strict limits on the time they spend in the sun” (Autier 2009). Though his conclusion has not been adopted wholesale by public health agencies, it is grounded in a growing body of evidence that raises basic questions about the efficacy of sunscreen for sunbathers and others intentionally seeking sun exposure.Clothing is an effective alternative. One study found that melanoma risk was cut by 52 percent for parts of the body usually covered by clothing during summer outdoor work (Holman et al 1986). EWG believes that hats and shirts are the best sunscreen of all.

Increased exposure to potentially hazardous ingredientsHigh-SPF products contain greater amounts of sun-blocking chemicals than low-SPF sunscreens. These ingredients may pose health risks when they penetrate through the skin, where they have been linked to tissue damage and potential hormone disruption. If studies supported a reduction in skin damage and skin cancer risk from high-SPF products, the additional exposures might be justified. But they don’t, so choosing sunscreens with lower amounts of active ingredients – SPF 30 instead of SPF 70, for example – is prudent.

SPF factors are based on two-to-five times more sunscreen than people actually useIn the real world, people get far less protection than the bottle advertises.Sunscreen makers establish a product’s SPF by testing their products on volunteers. The testers coat the volunteers’ backs with 2 milligrams of sunscreen per square centimeter of skin (mg/cm2), the amount stipulated in FDA’s draft sunscreen regulations (FDA 2007), and then expose them to sunlight-simulating UV radiation until a burn appears. The time needed to burn, divided by the time it takes to burn the volunteers’ unprotected skin, is the SPF.

In real life, people apply one-half to one-fifth the amount of sunscreen used in the laboratory SPF tests (Autier 2003, Azurdia 2001, Reich 2009). Because of the physics of sunlight, that cuts the


protection factor not by a factor of just 2 to 5, but by between the square root and the fifth root of the SPF. That’s a much steeper “exponential” cut in protection (Faurschou 2007, Schalka 2009, Kim 2010, Playtex 2007). For example, this means that someone who applies one-fourth as much sunscreen as in the SPF test gets just SPF 2.3 protection from an SPF 30 product. SPF 100 becomes just SPF 3.2.

How under-application of sunscreen cuts effective SPF(based on applying one-fourth the recommended amounts)

SPF on labelAverage SPF of users

at (0.5 mg/cm2)

% UV transmission (amount reaching

skin)15 2 50%30 2.3 43%50 2.6 38%100 3.2 31%

Source: EWG analysis of sunscreen efficacy based on a typical sunscreen application rate of one-fourth of 2 milligrams per square centimeter of skin (the SPF testing application amount).

A number of studies have confirmed people’s tendency to apply less sunscreen than is used in SPF testing. One study of 124 students found that the average application rate was one-fifth (0.39 mg/cm2) the testing amount (Autier 2003). Another study found that ten female volunteers applied a median thickness of sunscreen that was one-fourth (0.5 mg/cm2) the amount used in testing (Azurdia 2001). Even when researchers instructed volunteers on the proper amount to use, they applied too little: A study of 52 subjects found that uninstructed volunteers applied 34 percent of the recommended thickness, and even those who were instructed on how much to apply used only 43 percent of the recommended amount (Reich 2009).

The fact that people use less sunscreen than recommended is not an argument for using even higher SPF products to compensate. Higher SPF products produce small increases in real-world SPF. But even this small change allows sunbathers to stay in the sun longer – and absorb more overall radiation – before a sunburn sends them indoors. In the process, the substantially greater amounts of sunscreen chemicals in higher SPF products can penetrate the skin and lead to much higher internal exposures to potentially hazardous compounds. The user is left with a burn and a significantly higher “body burden” of sunscreen chemicals.


Getting enough vitamin DVitamin D is essential for many processes in the body, including maintaining healthy bones and a strong immune system and protection from cancer. It is formed in the skin through the action of the sun (Adams 2010). In human epidemiological studies, low vitamin D levels have been associated with increased cardiovascular mortality, metabolic disease and susceptibility to infections.

Yet over the last two decades, vitamin D levels in the U.S. population have been decreasing steadily, creating a growing epidemic of vitamin D insufficiency (Ginde 2009a). Seven of 10 children in the U.S. have low levels of vitamin D. Of those, nine percent have a serious deficiency and 61 percent have higher but still insufficient levels (Kumar 2009). Mirroring this national deficiency, 70 percent of breastfed babies are vitamin D deficient at 1 month of age (Wagner 2010), when such a deficiency can be particularly harmful because of vitamin D’s role in growth and development.

Sunscreen use combined with too little outdoor time contributes to vitamin D deficiencies, but experts disagree on whether short amounts of time in the sun or supplements are the best way to help a person deficient in vitamin D.

The many roles of vitamin DVitamin D is a fat-soluble hormone essential for bone growth in children and for maintaining healthy bone mass in adults. Vitamin D precursors are produced in the skin through the effects of the sun, converted into the active form of vitamin D in the kidneys and carried by the blood to the rest of the body (Adams 2010).

Vitamin D promotes intestinal calcium and phosphate absorption and calcium/phosphate release from the bone. Vitamin D deficiency is associated with rickets in children and osteoporosis in adults (Papandreou 2010).

Vitamin D is also produced by immune system cells as part of the body’s defenses against disease. People with low vitamin D levels are more susceptible to upper respiratory tract and other infections (Ginde 2009b).

In epidemiological studies, low vitamin D levels have been associated with increases in cardiovascular mortality, colon cancer mortality and breast cancer risk and tentatively linked to skin cancer, metabolic disease, hypertension and obesity (Adams 2010; Grant 2009; Tang 2010).

The role of sunshine in vitamin D productionUltraviolet (UV) light-induced vitamin D production can be inhibited by deep skin pigmentation, indoor lifestyles, older age, strict sun avoidance and other factors (Lucas 2006). Data from the


National Health and Nutrition Examination Survey (NHANES) conducted by the Centers for Disease Control and Prevention suggest that both increased use of sun protection and higher average body weight are associated with lower vitamin D levels (Looker 2008).

However, UV light exposure, whether from the sun or from artificial tanning, is also the most important environmental risk factor for skin cancer (International Agency for Research on Cancer 2001b). Over the past several decades, the incidence of the three most common forms — basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and malignant melanoma (MM) — has been steadily rising in the United States and other countries (Aceituno-Madera 2010; Gloster 1996). Physicians and scientists around the world universally agree that sun protection is essential to prevent skin cancers and reduce their toll on human health and well-being as well as health care costs (Gordon 2009). Yet strict sun protection has also been shown to cause vitamin D deficiency (Norval 2009; Reichrath 2009).

Expert opinions vary on the best way to address vitamin D deficiencies. The American Medical Association has recommended that everyone get 10 to 15 minutes of direct sun (without sunscreen) several times a week, an amount sufficient for adequate vitamin D production (AMA 2008, Brender 2005). The American Academy of Dermatology expressed a different opinion in its 2009 Position Statement that “there is no scientifically validated, safe threshold level of UV exposure from the sun that allows for maximal vitamin D synthesis without increasing skin cancer risk.” The Academy recommends increased intake of foods naturally rich in vitamin D, vitamin D-fortified foods and vitamin D supplements (AAD 2009).

According to a 2006 World Health Organization (WHO) report, Solar Ultraviolet Radiation: Global Burden of Disease from Solar Ultraviolet Radiation, it is important to focus on reducing the disease burden due to both excessive and insufficient UV exposure (WHO 2006). Using the disability-adjusted life year (DALY) as a metric, WHO experts estimated that excessive sun exposure caused the loss of approximately 1.5 million DALYs (0.1 percent of the total global burden of disease) and 60,000 premature deaths in the year 2000, with the greatest burden from UV-induced cortical cataracts and cutaneous malignant melanoma (WHO 2006). By comparison, the same group of scientists noted that a much larger annual disease burden of 3.3 billion DALYs worldwide would result from very low levels of UV radiation exposure due to disorders of the musculoskeletal system such as rickets and osteoporosis and possibly an increased risk of various autoimmune diseases and life-threatening cancers (Lucas 2008). Researchers concluded that “without high dietary (or supplemental) intake of vitamin D, some sun exposure is essential to avoid diseases of vitamin D insufficiency” (Lucas 2008).

The Institute of Medicine (IOM) of the U.S. National Academies is currently conducting a study to develop updated recommendations for adequate vitamin D intake (IOM 2010). This update is expected to cause a reconsideration of vitamin D deficiency in the general population and possibly


call for more frequent testing of vitamin D levels and vitamin D supplementation (American Medical Association 2009). Limited, appropriate sun exposure may also become more accepted as a step toward maintaining adequate vitamin D levels (Lucas 2006; Reichrath 2009).

New FDA data: Sunscreen additive may speed skin damageRecently available data from an FDA study indicate that a form of vitamin A, retinyl palmitate, when applied to the skin in the presence of sunlight, may speed the development of skin tumors and lesions (NTP 2009). This evidence is troubling because the sunscreen industry adds vitamin A to 41 percent of all sunscreens.

Source: EWG analysis of data from FDA photocarcinogenicity study of retinyl palmitate (NTP 2009). Percent decreases in time to development of a significant tumor or lesion (for animals exposed to cream laced with retinyl palmitate) are relative to that for animals exposed to cream free of the compound.

The industry includes it in its formulations because it is an antioxidant that slows skin aging. That may be true for lotions and night creams used indoors, but FDA recently conducted a study of


vitamin A’s photocarcinogenic properties, meaning the possibility that it results in cancerous tumors when used on skin exposed to sunlight. Scientists have known for some time that retinyl palmitate can spur excess skin growth (hyperplasia), and that in sunlight it can form free radicals that damage DNA (NTP 2000).

In FDA’s 1-year study, tumors and lesions developed up to 21 percent sooner in lab animals coated in a vitamin A-laced cream (at concentrations of 0.1% to 0.5%) than in control animals treated with a vitamin-free cream. Both groups were exposed to the equivalent of nine minutes of noontime Florida sunlight each day for up to a year.

The lowest level of vitamin A tested, 0.1%, accelerated tumor and lesion development by 11-13 percent compared to control animals. This amount is 50 times lower than the highest level of vitamin A deemed safe in personal care products (5 percent), as determined by the industry’s expert review panel in 2009 (the Cosmetic Ingredient Review panel, funded by the Personal Care Products Council trade association) (CIR 2009).

The FDA data are preliminary; the agency will publish its evaluation and conclusions in a report expected in October 2010. If the data hold up in FDA’s final assessment, they suggest that some sunscreens may increase the risk of skin cancer. In the meantime, EWG recommends that consumers avoid sunscreen with vitamin A (look for “retinyl palmitate” or “retinol” on the label).

New data supports long-standing FDA concerns about the safety of vitamin A

The FDA’s National Center for Toxicological Research (NCTR) and the National Toxicology Program (NTP) recently posted on the NTP website data from FDA’s long-term photocarcinogenicity tests of retinyl palmitate on UV-exposed laboratory animals. In the studies, animals treated with 0.1% and 0.5% retinyl palmitate (a form of vitamin A) developed skin tumors or lesions that grew significantly faster than mice treated with vitamin-free cream (NTP 2009).

FDA and NTP will publish their final assessment after they complete a full analysis and peer review of the data, with publication estimated for December 2010 (Howard 2010). EWG scientists independently assessed the data while the protracted government review proceeds.

EWG’s assessment strongly suggests that upon exposure to UV light, retinyl palmitate acts as a photocarcinogen and hastens the development of skin tumors and lesions. These results are in complete agreement with a large, existing body of research that includes several lines of evidence:

FDA scientists have shown that UV-exposed retinyl palmitate forms free radicals and causes •


DNA mutations (Cherng 2005; Mei 2006; Yan 2005).Studies since the 1970s have reported that a closely related compound, retinoic acid, enhances • UV-induced photocarcinogenicity in animal studies (Halliday 2000; NTP 2000).Finally, in studies with human volunteers, retinol and retinyl palmitate (which converts to • retinol after it absorbs through the skin) induced skin hyperplasia (Duell 1997), which is one of the effects found in the FDA photocarcinogenicity study.

As is well known, vitamin A (retinol or its modified form, retinyl palmitate) is an essential nutrient required for good health. Vitamin A and its derivatives have also become very popular cosmetics ingredients that are promoted as providing a variety of benefits, from slowing skin aging and preventing oxidative stress from free radicals to renewing skin cells and filtering UV rays (Sorg 2006).

Despite the purported benefits of vitamin A for the skin, for more than a decade the FDA has been concerned about its safety. The agency noted in 2000 that “cosmetic products containing retinyl palmitate are being marketed aggressively for rejuvenation of the skin” (NTP 2000), even though the safety of these ingredients in cosmetics had never been adequately demonstrated. In 2001 the agency called for extended phototoxicity and photocarcinogenicity studies of retinyl palmitate (Fu 2002).

In 2008 FDA researchers expressed additional concerns over the widespread use of vitamin A-based ingredients in products used by women of childbearing age. In excessive doses retinol acts as teratogen (a compound that causes birth defects). FDA scientists found that a woman’s dose of vitamin A from using creams could exceed safe levels: “Total body application of a formulation with a high retinol concentration may result in retinol systemic absorption that exceeds certain recommended daily limits for women of child-bearing age” (Yourick 2008).

FDA’s photocarcinogenicity study of retinyl palmitate (RP)The publicly available data from FDA’s new study suggest that when used in sun-exposed skin care products, retinyl palmitate and related chemicals may increase skin damage and elevate skin cancer risk instead of protecting the skin.

EWG analyzed the FDA data and determined that even the lowest concentration of retinyl palmitate tested (0.1%), was associated with increased growth rates of skin tumors and lesions (NTP 2009).The one-year study involved a hairless mouse strain (SKH-1), a well-recognized model for photocarcinogenicity research (Bucher 2002; FDA 2009; Halliday 2000; Yan 2007). Both male and female animals were used, with 34-36 animals per group. Testing included two concentrations of retinyl palmitate, 0.1% and 0.5%, administered topically in a cream vehicle.


Animals were exposed to solar simulated light (SSL) with UVA/UVB ratio of 20.5:1, close to the proportion of UVB in sunlight of 3-to-5 percent, depending on latitude (Garland 2003). The animals were treated with cream and RP in the morning and received four hours of UV exposure in the afternoon. Two levels of light intensity were tested, 6.75 and 13.7 mJ CIE/cm2, equivalent to 0.3 and 0.6 of a minimal erythemal (sunburn) dose (MED). One MED is a common unit of sun exposure, equivalent to the time it takes to cause a sunburn that persists for 24 hours. According to an FDA publication, 0.6 MED is equivalent to nine minutes of unprotected UV exposure to high intensity UV light (UV index of 10) (Yan 2007).

EWG analyzed the effect of the vitamin A dose on the length of time each animal remained in the study. Most were withdrawn and sacrificed when at least one skin tumor or lesion reached a significant, defined size. Though FDA did not publish the size at sacrifice for this study, in similar FDA photocarcinogenicity studies scientists sacrificed animals when tumors or lesions reached 5 to 10 millimeters in diameter (NTP 2007, 2008). Some animals may have been withdrawn before tumors and lesions reached that size if skin lesions began to merge (which would make it difficult to assess skin effects), or if the animals were otherwise ill. The reason for withdrawal is not available in the public data, so EWG was unable to distinguish between animals withdrawn because of large tumors, large lesions, or other reasons. The data show that at least 89 percent of vitamin-A exposed animals developed one or more tumors during the study, and large tumors were likely a significant reason for withdrawals.

The hairless mouse is highly susceptible to skin cancer, tumors and lesions under the conditions of this test. As a result, the speed at which these types of skin damage develop is an accepted indicator of harm (NTP 2007, NTP 2008).

EWG analyzed differences in the number of days recorded for each animal’s survival, a proxy for rate of tumor or lesion development. Animals treated with retinyl palmitate were withdrawn from the study 11-to-21 percent sooner than animals whose skin was treated with a neutral cream and exposed to the same doses of UV. These findings were statistically significant for both sexes and for each exposure group. Mice treated with only UV or only neutral cream combined with UV survived longer than animals exposed to vitamin A.


Source: EWG analysis of published data from FDA photocarcinogenicity study of retinyl palmitate (NTP 2009).

These findings are preliminary. The data will be analyzed in detail by the FDA and NTP research team in a report due in the fall of 2010. In the interim, however, EWG is concerned that sunscreens incorporating vitamin A may be harmful. EWG cautions consumers to select sun products free of the compound until more conclusive information is available. This caution extends to other forms of vitamin A as well – retinol, retinyl acetate, and other retinyls – which are expected to display common toxic properties and to pose similar safety concerns (NTP 2000).

Significantly shorter time to tumor or lesion formation (p<0.5 in all instances)

Mice

Cream with no RP Cream with 0.1% RP

Cream with 0.5% RP

Average days until animal was removed from study*

low UV 300 268 (-11%) 242 (-19%)high UV 248 217 (-13%) 195 (-21%)

*typically when a tumor or lesion reached a significant size

Data source: National Toxicology Program (NTP). Pathology Tables, Survival and Growth Curves from NTP Long-Term Studies. Technical Report Pathology Tables and Curves. TR-568 All-trans-retinyl palmitate. Available: http://ntp.niehs.nih.gov/index.cfm?objectid=555571BB-F1F6-975E-76F2BC5E369EB6F7

Note: Retinyl palmitate is a derivative of vitamin A and is in the family of vitamin A compounds. It is converted to vitamin A proper (retinol) when it is absorbed by the skin. The personal care product industry frequently uses retinyl palmitate and vitamin A synonymously, which we do as well on this page. One example of industry’s nomenclature use for vitamin A is Banana Boat’s listing of “Retinyl Palmitate (Vitamin A)” on the ingredient label of

its Baby MAX Protect & Play SPF 100 sunscreen.


Nanomaterials and hormone disruptors in sunscreensSunscreen makers offer mineral and non-mineral formulations, as well as products that combine both mineral and non-mineral active ingredients. Mineral formulations incorporate zinc oxide or titanium dioxide in nano- and micro-sized particles that can be toxic if they penetrate the skin. Most studies show that these ingredients do not penetrate through skin to the bloodstream, but research continues. These constitute one in five sunscreens on the market in 2010 and offer strong UVA protection that is rare in non-mineral sunscreens.

The most common ingredients in non-mineral sunscreens are oxybenzone, octisalate and avobenzone, found in 60, 58, and 50 percent of all sunscreens on the market, respectively. The most common, oxybenzone, can trigger allergic reactions, is a potential hormone disruptor and penetrates the skin in relatively large amounts. Some experts caution that it should not be used on children. Three of every five sunscreens rated by EWG are non-mineral, and one in five sunscreens combines both mineral and non-mineral active ingredients.

EWG reviewed the scientific literature on hazards and efficacy (UVB and UVA protection) for all active ingredients approved in the U.S. Though no ingredient is without hazard or perfectly effective, on balance our ratings tend to favor mineral sunscreens because of their low capacity to penetrate the skin and the superior UVA protection they offer.

Mexoryl SX (ecamsule) is another relatively low-risk, effective active ingredient that provides UVA protection, but it is sold in very few formulations. Tinosorb S and M appear to be both safe and effective but are not yet available in the U.S. For consumers who wish to avoid mineral products, sunscreens containing avobenzone are the best options (at its maximum allowable level of 3 percent for the best UVA protection). The potential hormone disruptors oxybenzone or 4-MBC appear to pose greater potential risks than other common sunscreens; EWG recommends against buying sunscreens that contain these compounds. Scientists have called for parents to avoid using oxybenzone on children due to penetration and toxicity concerns.

Oxybenzone – experts caution against using it on childrenOxybenzone is the most common active ingredient in sunscreen, found in 60 percent of the 500 beach and sport sunscreens in EWG’s 2010 database. Experts raise concerns about its use in sunscreens for children because of its ability to penetrate the skin and its association with allergic reactions and potential hormone disruption:

“It would be prudent not to apply oxybenzone to large surface areas of skin for extended •


and repeated periods of time unless no alternative protection is available. There may be an additional concern for young children who have less well-developed processes of elimination and have a larger surface area per body weight than adults, with respect to systemic availability of a topically applied dose.” — Hayden C, Roberts M, Benson H. 1997. Systemic absorption of sunscreen after topical application. Lancet 350(Sep): 863-64. “…with respect to [oxybenzone], our data raise some concerns regarding the formulation • of sunscreen products for specific application to children… whilst limited absorption across the skin was observed for the majority of the sunscreens tested, [oxybenzone] demonstrated sufficiently high penetration to warrant further investigation of its continued application.” — Jiang R, Roberts MS, Collins DM, Benson HAE. 1999. Absorption of sunscreens across human skin: an evaluation of commercial products for children and adults. British Journal of Clinical Pharmacology 48(4): 635-37. “It is evident that [oxybenzone] undergoes conjugation in the body to make it water soluble. • However, we do not know at what age the ability to conjugate is fully developed, and therefore for children physical filters such as titanium dioxide and/or zinc oxide might still be considered a more appropriate sunscreen component.” — Gonzalez HG, Farbrot A, Larko O. 2002. Percutaneous absorption of benzophenone-3, a common component of topical sunscreens. Clinical and Experimental Dermatology 27(8): 691-94.

Sunscreen chemicals: exposure and toxicity concerns

Sunscreens are used frequently over large portions of the body, which heightens the concerns over exposure.

A number of sunscreen chemicals are known to permeate the skin, based on laboratory studies, tests on volunteers or human biomonitoring studies that have detected these chemical in the general population. In the United States the widely used chemical oxybenzone (or benzophenone-3) is detected in 96 percent of the population (Calafat 2008, Wolff 2007). A recent European study detected four common sunscreen chemicals in mothers’ milk, indicating potential for ongoing exposure to the developing fetus and newborn (Schlumpf 2008). Indications of human exposure underscore the need for FDA and other regulatory agencies to carefully consider the toxicity of widely used sunscreen ingredients.

With this in mind EWG evaluates US-approved sunscreen chemicals for both their ability to block UV radiation and toxicity. the table below summarizes human exposure and toxicity information for 14 US-approved sunscreens and three ingredients pending approval by the FDA. Ingredients are flagged for the following concerns:

Human exposure – resulting from sunscreen chemicals penetrating skin and reaching sensitive organs or hormone receptors


Hormone activity – which can impact the regulation of the reproductive, nervous, thyroid and immune systems, particularly if exposures occur during pregnancy or childhood.

Other toxicity concerns—including sun-related skin allergy, effects on skin and breakdown products

No ingredient is without concerns; EWG’s rating system for sunscreens takes into account the range of concerns and differences in the weight of the evidence for each active ingredient.

Sunscreen chemicalPercent of U.S. sunscreens con-taining it

Exposure (skin penetration and biomonitoring) Toxicity concerns

Sunscreens with highest concern for human exposure and toxicity

4-Methylbenzylidene camphor (4-MBC)

FDA approval pending

Limited skin penetration (1%) in vivo 1-3. Detected in European mothers’ milk at low parts per billion levels 4

Strong evidence of hormone disrup-tion 5-7; 8 9 10; thyroid effects 5; be-havioral alterations in female rats 11

Benzophenone-3 (oxy-benzone) 60%

1-9% absorbed according to in vivo skin studies 1, 2, 12, 13; detected in volunteers’ urine 14, 15 and in European moth-ers’ milk 4. Present in 96% of Americans’ urine 16, 17; higher maternal exposures are as-sociated with a decrease in birth weight for girls and an increase in boys 18

Hormone disruption 19-22; repro-ductive effects and altered organ weights in chronic feeding studies 23. High rates of photo-allergy 24.

3-Benzylidene camphor FDA approval pending

Hormone disruption 8; in vivo effects—behavior and estrous cycling 11

Octyl methoxycinna-mate (OMC) 40%

Limited skin penetration in vivo <1% 12, urine 1, 2, 14 and in European mothers’ milk at low parts per billion levels.4

Multiple estrogenic effects 5, 6, 19; 21. Thyroid hormone reductions 25; and hormone-mediated immune effects.26 Moderate rates of skin al-lergy. {Rodriguez, 2006 #2683}

Padimate O 1.0%

Limited skin penetration.27 Detected in European moth-ers’ milk at low parts per billion levels.4

Estrogenic effects 19, 28 8. Damages DNA 29: causes allergic reactions in some people.

Sunscreens with moderate concern for human exposure and toxicity

Octocrylene 49%Limited skin penetration in vivo 27. Detected in European mothers’ milk.4

Slight to moderate skin irritation.30


Ensulizole 1.2%Skin penetration measured in vivo, documented concentra-tions in urine.31

Occasional photoallergic reactions reported.32, 33

Homosalate 45%Limited skin penetration in vivo <1% 12. Not detected in European mothers’ milk.4

Limited evidence of hormone dis-ruption.8, 19, 22, 28. Toxic metabolites 34

Sulisobenzone (Benzo-phenone-4) 0.2% Skin penetration measured 35,

estimated at 1%.36Limited evidence of hormone dis-ruption.37

Zinc Oxide 29%

Very limited skin penetra-tion.38 Estimated at 0.4% in volunteers for nano- and conventional partical sizes. Unknown whether it is in elemental (harmless) or in-soluble particle form (toxico-logically harmful)39

No photoallergy or hormone disrup-tion. Skin cell study found zinc nanoparticles provoked oxidative stress and DNA damage 40. Coatings may reduce skin reactivity. Zinc in-halation causes lung inflammation.41

Titanium Dioxide 28%

Very limited skin penetra-tion 38: penetration of hairless mouse skin 42: no skin pen-etration in min-pigs 43.

No photoallergy or hormone disrup-tion. Probable carcinogen when in-haled 44. Inhaled nanoparticles reach organs, cross placenta and enter brain.45-47 Skin damage in vitro 48.

Sunscreens with lowest concern for human exposure and toxicity

Avobenzone 50% Limited skin penetration in vivo 27; and in vitro (0.8%) 3, 49

No evidence of photoallergy or hormone disruption.

Mexoryl SX

Limited approval (4 formulations); broader FDA ap-proval pending

Limited skin penetration in vivo (0.16%).50

No evidence of hormone disruption. Rarely reported skin allergy, more often in children. 51

Octisalate 59%Limited skin penetration in vivo <1%.12 and in vitro (~0.5%).52

Rarely, allergic contact dermatitis.53

Tinosorb M FDA approval pending

Low skin penetration mea-sured in vitro.54

No in vitro hormone effects. Did not stimulate uterotrophic activity in vivo.55 Allergic reactions uncom-mon.56

Tinosorb S FDA approval pending

No in vitro hormone effects; did not stimulate uterotrophic activity.55

4 other ingredients approved in the United States are almost never used in sunscreen, and poorly studied: Menthyl Anthranilate, Benzophenone-8, PABA and Trolamine salicylate Table references: 1 – Janjua 2004. 2 – Janjua 2008. 3 – Klinubol 2008. 4 – Schlumpf 2008. 5 – Seidlova-Wuttke 2006. 6 – Seidlova-Wuttke 2006. 7 – Schlumpf 2004. 8 – Schreurs 2005. 9 – Durrer 2007. 10 – Maerkel 2007. 11 – Faass 2009. 12 – Sarveiya 2004. 13 – Gonzalez 2006. 14 – Hayden 1997. 15 – Felix 1998. 16 – Calafat 2008. 17 – Wolff 2007. 18 – Wolff 2008. 19 – Schlumpf 2001. 20 – Schlumpf 2004. 21 – Schreurs 2007. 22 – Ma 2003. 23 – NTP 1992. 24 –


Rodriguez 2006. 25 – Klammer 2007. 26 – Rachon 2006. 27 – Hayden 2005. 28 – Gomez 2005. 29 – McHugh 1997. 30 – Odio 1994. 31 – Vidal 2003. 32 – Berne 1998. 33 – Schauder 1997. 34 – SCCP 2007. 35 – Kurul 2001. 36 – Benech-Kieffer 2000. 37 – Molina-Molina 2008. 38 – Nohynek 2007. 39 – Gulson 2010. 40 – Sharma 2009. 41 – Sayes 2007. 42 – Wu 2009. 43 – Sadrieh 2010. 44 – IARC 2006. 45 – Takeda 2009. 46 – Shimizu 2009. 47 – Park 2009. 48 – Pan 2009. 49 – Montenegro 2008. 50 – Benech-Kieffer 2003. 51 – FDA 2006. 52 – Walters 1997. 53 – Shaw 2006. 54 – Mavon 2007. 55 – Ashby 2001. 56 – Gonzalez-Perez 2007. [click here for full reference list]

FDA’s 32-year failure to set sunscreen standardsIn August 1978 FDA began developing comprehensive regulations for sunscreen safety and effectiveness. Nearly 32 years have passed, yet the agency has yet to issue final regulations. As a result, sunscreen manufacturers in the U.S. are free to market products that do not offer the best available combination of safety and effectiveness. As well, manufacturers can make advertising claims unsupported by mandatory testing.

FDA’s inaction has left consumers to wonder which of the hundreds of sunscreens on the market work best for themselves and their families. Click here to read EWG’s letter urging FDA Commissioner Margaret Hamburg to issue the long-awaited sunscreen safety regulations.

FDA officials say that many manufacturers voluntarily abide by a set of sunscreen regulations issued in 1999 but never went into effect. These regulations listed 16 compounds that could be used as “sunscreen active ingredients,” the combinations in which they could be used and their maximum acceptable concentrations. It would have required manufacturers to conduct sun protection factor (SPF) testing for UVB radiation and would have provided a standardized methodology for UVB testing and determination sunscreens’ water resistant properties. (FDA 1999).

Yet since these regulations are not legally binding, the sunscreen industry operates in a legal gray zone. The agency still has nothing more than a set of unenforceable recommendations when it comes to what manufacturers can put in their sunscreens and what claims they can make about them (FDA 2006b).

The 1999 regulatory scheme was stayed indefinitely for several reasons. For one thing, the Cosmetic, Toiletry and Fragrance Association (CTFA) filed a petition objecting to aspects of the proposal (FDA 2000). For another, FDA officials thought it ignored the emerging issue of UVA radiation. They decided to attempt to develop UVA testing methods and guidance.

In August 2007, the FDA issued a new set of proposed rules, updated to cover UVA protection (FDA 2007). It is this plan that awaits final action from the agency.The U.S. lags far behind Europe, Japan and Australia in providing consumers with high quality sunscreens. The FDA is also slow to evaluate and approve better sunscreen ingredients and allow


new combinations, making it impossible for U.S. formulators to achieve the highest level of UVA protection in products (Osterwalder 2009).

In 2002, FDA invented a new process to speed approval for sunscreens that have been used for at least five years in other countries. Over the last seven years, sunscreen makers have submitted applications for seven sunscreen ingredients (amiloxate, 4-MBC/enzacamene, octryl triazone, Tinosorb S and M, iscotrizinol and ecamsule/Mexoryl). The FDA has still not approved them for use in to U.S. products. (Osterwalder 2010) Most critical are the three UVA filters. Applications for Tinosorb S and M were submitted in 2005. Mexoryl SX (ecamsule) was approved for use in Europe in 1991 and didn’t reach the United States until 15 years later. It presently can only be sold by L’Oreal’s La Roche Posay at a maximum SPF of 15 (Barron 2002). Application for broader uses was submitted in 2007.

These ingredients could enable sunscreen makers to come up with more UVA protection options.If the regulatory proposal now under consideration takes effect in its current form, consumers’ choices may be improved in several respects. First, prospective purchasers would be clearly warned that most sunscreens do not adequately protect them from UVA exposure. Groundless claims like “all day protection,” “waterproof ” and “sweatproof ” would not pass muster. Exaggerated SPF claims would prohibited. (FDA 2007).

Even then, other serious shortcomings would remain:

UVA protection would not be required.• The level of UVA protection if any, would be disclosed with a 0-to-4 star rating system.• FDA would still lack key data essential data to determine ingredient safety.•

Laboratory studies indicate that some sunscreen ingredients can be toxic in some situation causing pre-cancerous cell damages, hormone disruption and possibly reduced birthweight (Gulson 1999, Schlumpf 2001, Wolff 2009). FDA has not announced plans to require detailed investigation of these effects. Other concerns include an ingredient’s photostability alone and in combination with other sunscreen ingredients (Gonzalez 2007). The detection of several common UV filters (octylmethoxycinnamate, octrocrylene, oxybenzone, 4-MBC, and Padimate O) in women’s breast milk raises concerns about toxicity to the gestating fetus and newborn (Schlumpf 2008).

Moreover, U.S. formulators would still have fewer approved UV filters to work with than counterparts in other countries.

Inactive ingredients may undermine skin protection. Active ingredients in sunscreen are typically less than 25 percent of a product’s total volume. Inactive ingredients may also pose concerns if they enable certain chemicals to penetrate the skin more easily, cause cell damage or undermine the


stability of UV filters.

Too little is known about nanomaterials in sunscreen. Other countries have taken a closer look at the potential risks posed by nanoscale ingredients in body care products. The EU Scientific Committee on Cosmetics denied approval for micronized zinc oxide as a sunscreen in 2003, citing a lack of data on skin absorption and inhalation and studies showing potential toxicity in the presence of UV light (SCCNP 2003; SCCP 2005). In 2007 the EU panel called for a safety assessment of insoluble nanoscale products, among them zinc oxide and titanium dioxide (SCCP 2007).

A 2007 EU-funded study concluded that there was little risk of nano-size titanium dioxide penetrating through intact skin (NanoDerm 2007).) The same year, an FDA task force on nanotechnology urged more extensive study of nanosize ingredients in products (FDA 2007).EWG research has identified nearly 9,800 personal care products containing nanoscale ingredients or ingredients that may contain a nanoscale fraction, but there has been no systematic effort to assure that these ingredients are actually safe (EWG 2006).

FDA must modernize its assessment of sunscreen ingredients and product efficacy. Stable, non-penetrating UV filters with fewer toxicity concerns, like Tinosorb and Mexoryl, should be made available on the U.S. market.

Does sunscreen damage your skin?Higher-energy UVB rays are the primary cause of sunburn, and bind directly to DNA causing pre-cancerous mutations. However, the sun’s more numerous lower-energy UVA rays penetrate deeper into skin tissue and are most responsible for generating free radicals that may damage DNA and skin cells (Marrot 2005), promote skin aging (Wlasckek 2001), and cause skin cancer (Wittgen 2007).

Sunscreens can help reduce UV-related free radical damage by diverting the radiation from the skin, but the ingredients themselves can release their own free radicals in the process. When the sunscreen molecules absorb UV energy, diverting it from the skin, the molecules dispel this excess energy by releasing free radicals. In a delicate balancing act, an effective sunscreen prevents more free radical damage (from UV radiation) than it creates through its own free radical generation. It reduces UV exposure without itself damaging skin. Sunscreen makers commonly add antioxidants to their products to soak up free radicals from either source, UV radiation or sunscreen itself.

Most of the US-approved UV filters release free radicals – octylmethoxycinnamate, oxybenzone, Avobenzone, octocrylene, titanium dioxide, zinc oxide, Padimate O, PABA, menthyl anthranilate, and Mexoryl SX (Allen 1996, Beeby 2000, Cantrell 1999, Damiani 2007 & 2010, Dondi 2006, Hidaka 2006, Knowland 1993, Sayre 2005, Serpone 2002). Some benzophenones, octisalate, and Mexoryl


appear to produce no free radicals (Allen 1996, Fourtanier 2008).

Sunscreens typically do more good than harm in this regard (Popov 2009, Serpone 2006, Haywood 2003). But they could be better. Tests show that sunscreen generally diminishes the formation of these free radicals—one study indicates a 45% reduction at typical amounts and a 55% reduction at the 2 mg/cm2 recommended use. This would be equivalent to a “free radical protection factor” of 2, not the 15 to 50 SPF common for sunburn protection (Haywood 2003).

The balance may shift if people apply too little sunscreen or reapply infrequently. For example, a study found that for 3 common sunscreens the amount of free radicals caused by sunscreen exceeds the amount on untreated skin after 1 hour (Hanson 2006).

Particular sunscreen ingredients or formulations may be more damaging to skin than others. Both nano-size zinc oxide and titanium dioxide, including forms extracted from sunscreen, react strongly with UV light (Dunford 1997) and may damage skin cells (Sharma 2009). Manufacturers typically use coatings that reduce activity (Popov 2009, Serpone 2006). Furthermore the crystal structure of titanium dioxide (anatase vs. rutile) also appears to affect its potency in free radical generation (Lu 2008).

The UV filter Padimate O causes skin damage through an entirely different mechanism. It fell out of industry’s favor when evidence emerged that it reacts with other compounds to form a mutagenic contaminant (Loeppky 1991) and causes a dramatic increase in DNA strand breaks relative to untreated skin (Gulson 1999). It is difficult to gauge the effectiveness of a particular sunscreen formulation at combating free radicals. Zastrow (2004) has proposed an Integrated Sun Protection index that would quantify the degree of free radical formation under UV light.

Europe’s better sunscreensSunscreen makers can use any of 27 sunscreen chemicals in Europe but only 17 in the United States (Osterwalder 2010). Seven approved compounds that absorb UVA radiation are available in Europe, only three in the U.S. Among those approved in Europe are three – Tinosorb S, Tinosorb M and Mexoryl SX – that are between 3.8 times and 5.1 times more protective than avobenzone, the most common UVA filter in the U.S. (see figure).

Five years ago companies began to apply for FDA approval to use some of these compounds. They are still waiting.


Source: EWG analysis of UV protection factor using standard industry sunscreen model (BASF 2010), assuming percentage of active ingredient in product equal to maximum allowable amount, or the concentration a company requested that FDA approve for use in sunscreen in the company’s submitted Time and Extent Application.

CIBA Specialty Chemicals Inc. applied in April 2005 for approval of Tinosorb S and Tinosorb M. Sunscreens in Europe have contained these compounds for a decade; FDA has not yet acted.

Loreal submitted an application for Mexoryl SX in September 2007. FDA has not approved the compound for general use in sunscreens but did approve it for use in a small number of specific sunscreens sold under Loreal’s “LaRoche-Posay” brand. Mexoryl SX has been on the market in Europe since 1991.

The upshot of FDA’s delays is that Americans have fewer choices and notably poorer UVA protection than is available in Europe.

Tinosorb S and Tinosorb M offer stable, broad-spectrum protection and appear to be much better UVA blockers than avobenzone. They penetrate the skin in insignificant amounts, pose fewer potential health risks and possess no known hormone-disrupting properties, unlike ingredients in


common U.S. sunscreens. Unless FDA approves them, not a single sunscreen sold in the U.S. will earn FDA’s four-star top rating for UVA protection under the system proposed in the agency’s draft sunscreen regulations, based on a standard industry model for rating sunscreen efficacy (BASF 2010).

In Europe as in the US, UVA regulations have not been finalized. But Europe’s proposed standards for UVA protection are far more stringent than FDA’s. The agency has spent years finalizing a rule that would merely require disclosure of UVA protection levels, while Europe has proposed that sunscreens provide UVA protection at a level at least one-third as strong as the sunburn protection level (SPF) (European Commission 2006).

This means the minimum UVA protection in Europe would be roughly equivalent to FDA’s proposed three-star protection level. Requiring balanced protection across the UVB and UVA spectrum has the secondary effect of limiting sky-high SPF values, ensuring that sunburn protection isn’t out of step with protection from other health problems, such as free radical damage and skin cancer. Very few sunscreens on the U.S. market would meet the baseline UVA protection standards proposed in Europe (Osterwalder 2009).

While the FDA fails to act on modernizing sunscreen standards and expanding the roster of approved chemicals, Americans continue to be exposed to more UV radiation than ever.

Study methodologyAuthors of EWG’s 2010 sunscreen investigation include (listed alphabetically): David Andrews, PhD, Senior Scientist; Sean Gray, MS, Senior Analyst; Jane Houlihan, MSCE, Senior Vice President for Research; Nneka Leiba, MPH, Research Analyst; Sonya Lunder, MPH, Senior Analyst; Olga Naidenko, PhD, Senior Scientist.

Summary of Methodology

EWG’s 4th annual analysis of sunscreens includes safety and effectiveness ratings for 1,400 SPF products, including sunscreens and SPF-labeled lip balm, makeup, and moisturizer. Our ratings are based on an in-house compilation of standard industry, government and academic data sources and models that we have constructed over the past six years, and on a thorough review of the technical literature for sunscreen. We have incorporated sunscreen ratings from this investigation into our Skin Deep cosmetic safety database, an online consumer tool available at www.cosmeticdatabase.com.We based our analysis on sunscreen ingredient listings obtained primarily from online retailers. We rated products for overall safety and efficacy in sun protection considering five factors:


Health hazards associated with listed ingredients (based on a review of nearly 60 standard • industry, academic, and government regulatory and toxicity databases).UVB protection (using SPF rating as the indicator of effectiveness);• UVA protection (using a standard industry absorbance model);• The balance of UVA/UVB protection (using the ratio of UVA absorbance to SPF); and• Stability (how quickly a sunscreen ingredient breaks down in the sun, using an in-house stability • database compiled from published findings in industry and peer-reviewed stability studies).

Our calculated, overall rating for each product reflects a combination of the product’s health hazard rating and efficacy rating.

The methods and content of our analysis are based on our review of the technical sunscreen literature, including hundreds of industry and peer-reviewed studies. We compiled the results of our analyses in an online, interactive sunscreen guide. The details of our methodology are described below.

What’s new in 2010?EWG’s 2010 Sunscreen Guide reflects the latest science on UV exposure and sun protection. Changes from the previous year include:

UVA-UVB balance. We updated our rating of sunscreen efficacy to give greater weight to UVA-UVB balance, reflecting a growing consensus that balanced protection across the sun’s UVA-UVB spectrum better protects sunscreen users (AAD 2009b, FDA 2007). We increased the weight given to UVA-UVB balance in the overall product rating. We moved from relying on modeled SPF for calculating balance, to using manufacturers’ listed SPF values, better capturing product imbalance, particularly for high SPF products.

Absorbance spectra. We have updated the absorbance spectra for active ingredients in cases where new data were available. These inform our evaluations of the effectiveness of each sunscreen in protecting users from UV radiation.

Health hazard ratings. Hazard ratings reflect hazard data compiled for all sunscreen ingredients, active and inactive, as in past years. But in 2010 hazard scores are weighted to account for the percent of active ingredients in products, reflecting the potential for greater exposures as concentrations increase.

Significant concerns for sunscreens. We have given additional weight in our calculated hazard


scores for properties of particular concern for sunscreens, including for products that contain oxybenzone or vitamin A, products in a spray or powder form that may pose risk when inhaled, and products listing SPF values exceeding “SPF 50+,” the limit proposed by FDA in their 2007 draft sunscreen rule (FDA 2007). For sunscreens with a single significant concern, we assigned a rating of no lower than 3 (moderate hazard), and for sunscreens with two or more significant concerns, we assigned a rating of no lower than 7 to reflect a higher level of concern for these products.

Sunscreen rating system — Summary

Our sunscreen rating system is based on a product-by-product analysis of safety and effectiveness. In our analysis of a product’s effectiveness we weigh four factors: UVA and UVB protection, balance, and the stability of active ingredient combinations. We combine these factors to derive a product effectiveness (sun hazard) rating. In our analysis of product safety we assess the potential for skin absorption and health hazards for all active ingredients (FDA-approved sunscreens) and all inactive ingredients to derive a product safety (health hazard) rating. We combine these two product ratings, effectiveness and safety, to derive an overall product rating using the following algorithm:

The sunscreen efficacy is calculated by taking 28% of the UVB protection + 28% of the UVA protection score + 28% of the UVA/UVB balance score + 16% of the sunscreen stability score. This is then combined with the health hazard score using at a variable ratio. For high hazard (health hazard score of 7 and higher), the efficacy score and health hazard score are combined at a 1:1 ratio. Using a linear regression, the efficacy score ratio is increased to 2:1 when the health hazard score reaches 0. This combined score is rounded to the nearest integer between 0 and 10.

In 2010 we also added a final step to flag sunscreen-specific hazards. Recent data suggest that sunscreens should not contain oxybenzone or vitamin A; not be aerosolized or powder; nor list SPF values over “50+”. Products with 1 of these hazards can not have a final score <3, products with 2 of more of these concerns cannot score better than 7. Powdered sunscreens cannot be scored better than 7 due to intense concerns about inhalation toxicity.


Also in 2010, we added a score to account for UVA-UVB balance in sunscreens. There is growing awareness of ideal sunscreens offer reasonably similar protection across the UV spectrum. The growth of ultra high SPF sunscreens further exacerbates this problem, as UVA protection currently maxes out at about 20 in U.S. sunscreens (BASF 2010).

Sunscreen Efficacy (Sun Hazard)Overview of sunscreen efficacy evaluation

In our analysis of a product’s effectiveness we weigh the four contributing factors (Shaath 2005): UVA protection; UVB protection; UVA/UVB balance; and the stability of active ingredient combinations, considering both the potential for active ingredient molecules to break down in sunlight, to react with other ingredients, or to otherwise transform into compounds less effective at filtering UV radiation. We assign a score for each of these factors based on an evaluation of data and technical literature.

We derive an overall rating for product effectiveness (sun hazard) as the sum of these 4 factors, each weighted by our judgment of their relative importance. In this calculation we assign a weight of 0.28 to each of UVA and UVB protection and balance, and a weight of 0.16 to stability. The procedures we used in our analysis of sunscreen efficacy are described below.

Absorbance spectra for individual active ingredients

About absorbance spectraAbsorbance spectra are determined through experiments in which researchers measure the amount and type of UV light filtered out by an ingredient or ingredient combination at every wavelength along the UVA and UVB spectrum. With absorbance spectra researchers determine the theoretical effectiveness of sunscreen ingredients and sunscreen products to prevent UV radiation from reaching the skin.We based our analysis of sunscreen effectiveness in part on the absorbance spectrum of each active ingredient.


Example: modeled absorption spectrum of octyl methoxycinnamate

Figure 1: Source (Herzog 2002)

EWG uses the reported SPF and our calculated absorbance spectra to determine the UV blocking strength for the ingredients listed in this report. We gathered the absorbance data for each active ingredient in a sunscreen from a variety of published scientific sources, listed below.With these absorbance spectra we calculate the amount of UV radiation expected to be blocked (i.e., absorbed or scattered) along the UVA and UVB wavelengths. We use these calculations to aid in assessing the effectiveness of products. Table. Sources for absorbance spectra used in EWG sunscreen analysisIngredient Source4-Methylbenzylidine camphor (4-MBC)

(Vanquerp, Rodriguez et al. 1999)

Avobenzone (Parsol 1789 | Butyl Methoxydibenzoylmethane)

(Bonda 2005; BASF 2010)

Ensulizole (Phenylbenzimidazole Sulfonic Acid)

(Inbaraj, Bilski et al. 2002)

Homosalate (Sánchez and Cuesta 2005)Menthyl Anthranilate (Beeby and Jones 2000)Mexoryl SX (Herzog, Hueglin et al. 2005)


Nano Titanium Dioxide (Schlossman and Shao 2005)1

Nano Zinc Oxide(Schlossman 2005; EWG 2010; BASF 2009; Nanox 2009)1

Octinoxate (Octyl Methoxycinna-mate)

(Bonda 2005)

Octisalate (Octyl Salicylate) (Krishnan, Carr et al. 2004)Octocrylene (Sánchez and Cuesta 2005)Oxybenzone (Benzophenone-3) (Vanquerp, Rodriguez et al. 1999)Padimate O (Octyl Dimethyl PABA | PABA Ester)

(Krishnan, Carr et al. 2004)

Sulisobenzone (Benzophenone-4) (Sánchez and Cuesta 2005)Tinosorb M (Herzog, Hueglin et al. 2005)Tinosorb S (Herzog, Hueglin et al. 2005)

1 For inorganic active ingredients – titanium dioxide and zinc oxide – the “absorbance spectra” also takes into account the chemical’s ability to scatter UV radiation in the UVA range (Schlossman and Shao 2005). Two different Zinc Oxide spectra are used to reflect the large variation in efficacy with changing particle size. The default categorization for Zinc Oxide ingredients is a particles size <100nm.

Absorbance spectra are represented in most of these sources either in graphic or tabular format as a function of wavelength. To use these absorbance spectra in our computations of sunscreen effectiveness, we developed an equation to represent each measured spectrum. When necessary, we digitized the graphical absorbance spectra from the sources listed above. We used the graphing and statistical analysis software package xmGrace (Turner, Team et al. 2004) to determine the best-fit polynomial expression for each absorbance spectrum. The maximum error between the digitized data and final fitted values was 1%, and for any given point was less than 0.05% in most cases.

Monochromatic Protection Factor (MPF) and transmission spectra for individual ingredients and products Both SPF and MPF are unitless factors that provide a measure of the amount of UV radiation blocked by sunscreen. SPF is a single value, while MPF varies based on wavelength. In the U.S. SPF is derived from sunburn experiments on human volunteers, while MPF is derived from lab measurements of UV transmission (Herzog 2005). SPF can also be computed by combining the MPF spectrum with the effective action spectrum (EA) for sunburn (a measure of how much damage a particular wavelength of light will cause) (McKinlay and Diffey 1987).

The MPF is a measure of the amount of UV radiation blocked (i.e., absorbed or scattered) at a particular wavelength. It is a key component in our evaluation of sunscreen effectiveness. We developed UV transmission spectra for individual active ingredients and for all combinations


of active ingredients in products that we assessed. We use the MPF transmission spectrum in our sunscreen report both to graphically represent the effectiveness of sunscreen products and ingredients across the UV spectrum, and to calculate the effectiveness of products in the UVA range. (We use SPF instead of MPF as the measure of product effectiveness in the UVB range.)

We computed the MPF transmission spectra following the method detailed by Herzog and implemented by the BASF sunscreen simulator (formerly the Ciba sunscreen simulator) (Herzog 2002; Herzog 2006; BASF 2010). This model accounts for the effect of uneven skin surfaces, with skin acting as a series of ridges and valleys instead of a smooth surface. The model represents sunscreen on the skin as a thin film distributed unevenly on the skin. The sunscreen thickness is modeled using a continuous height distribution that matches a gamma distribution function (Ferrero 2003). The use of the gamma method provides a significant improvement in calculated correlation with measured SPF in relation to the previously used 2-step model (O’Neill 1984).MPF is given by:

where T is the percent transmission of light; is the average molecular absorption coefficient (defined in Herzog), c is the average molar concentration of the active ingredients in moles/liter, d is the path length (20 micrometers is the assumed thickness of sunscreen based upon the recommended applied dose of 2 mg/cm2), and g and f are parameters that were fitted by Herzog (Herzog 2002; Herzog 2006) to match experimental data of European sunscreens and equal 0.269 and 0.935, respectively. Once the transmission spectrum is obtained, it can be transformed into an absorbance spectrum and monochromatic protection factors (MPF).

We used the Herzog method (Herzog 2002; Herzog 2006) described above to compute the UV transmission spectra both for individual ingredients and for all variations of active ingredients in the products we assessed. The method requires as input the concentrations of active ingredients. In computations of MPF spectra for individual ingredients, we used the average concentration of that ingredient found in products we assessed. In computations of MPF spectra for products, we used the concentrations of active ingredients specified on the product label. For some products in our database the concentrations of active ingredients were not available from our data sources. In those cases, we used the following heirarchy to establish assumed concentrations of active ingredients used in our MPF analysis:

Average concentration of active ingredient for products with the same SPF and active • ingredient combination.Average concentration of active ingredient for products with the same SPF and active •


ingredient in a different combination.Average concentration of active ingredient for products with the same ingredient combination • over all available SPFs.Average concentration of active ingredient for all products containing that active ingredient.•

We evaluated sunscreen effectiveness for a product based in part on our computation of the transmission spectrum for the product’s combination of active ingredients. We integrate over the combined effective absorbance spectrum as described by Herzog (Herzog 2002; Herzog 2006), over 1 nm wavelength intervals to obtain overall sunscreen product spectra based on the individual ingredient spectra described above. The spectral information is presented in this report over 10 nm wavelength intervals.

A sunscreen product must generally contain multiple active ingredients to achieve a high SPF rating due to FDA-imposed concentration limits and constraints on product formulation (Chatelain and Gabard 2001). In graphic representations of “UV blocking” in this report, we present the MPFs in 10 nm intervals for each active ingredient.

Evaluating products’ effectiveness for UVA protection

About UVA radiationUnlike sunburn protection there is no universally accepted test or metric for UVA protection and in the absence of biological action spectrum broad consensus is unlikely. The need for strong UVA protection is now broadly recognized yet many sunscreen fail to provide it (AAD 2009). Overexposure to UVA radiation has been hypothesized to increase your melanoma risk (Coelho 2010, Gorham 2007).

Indoor tanning salons which deliver a much higher portion of UVA radiation in relation to sunlight were recently listed by the International Agency for Research on Cancer as known human carcinogen due to the 75% increase in melanoma associated with use before the age of 35 (IARC 2009). UVA-induced oxidative stress affects the skin’s ability to protect itself, damaging DNA and chromosomes and potentially contributing to skin cancer (Nelson, 2005).

The FDA has not agreed on a single, standardized test to capture the UVA protection of a sunscreen. In 2007 they proposed a combination of an in-vivo and in-vitro test. EWG selected 2 methods, a UVA protection score which calculates the magnitude of mean UVA protection and a balance factor that roughly calculates the similarity of the UV exposure to unfiltered natural sunlight.


Calculating the UVA protection score In evaluating the overall UVA effectiveness a second UVA metric is calculated, the percent UVA light blocked or absorbed. This is useful because it captures the intensity of UVA protection. This value is calculated by integrating the MPF between 320-400nm.

Using this method, a score was assigned to each product:Percent UVA blocked or ab-sorbed

>=93.6% >=92.0% >=90.0% >=87.5% >=84.4% >=80.0% >=75.0% >=68.8% >=60.0% <60.0%

UVA Protection Score

0 1 2 3 4 5 6 7 8 9

Standard methods are needed to assess UVA protection. These methods were selected as an interim method for informing present day consumer choices. More robust in-vivo methods should be developed for measuring UVA protection. The American Academy of Dermatologists recommends an in-vivo method, such as persistent pigment darkening, or immediate pigment darkening (AAD 2002). However, the development and standardization of new methods is the responsibility of FDA and cosmetic companies, and should include a comparable metric that is relevant to human health. The cosmetics industry first raised this issue in 1996 (CTFA/NDMA 1996), and 14 years later, consumers still have no basis to know if a product adequately products from UVA rays.

Evaluating products’ balance for UVA/UVB protectionIn conjunction with providing UVA protection the need for this UVA protection to scale with SPF protection has been recognized by the American Association of Dermatology, the FDA, and globally by the sunscreen regulating agencies of the EU, the UK, and Australia.

In assessing the UVA-UVB balanced protection of a product, we shifted from using the spectral uniformity index, our procedure in 2009, to basing our balance rating on the ratio of UVA-PF to the labeled SPF. This improved method better accounts for imbalance, particularly in the high SPF range, and relies directly on manufacturer’s measured SPF values as opposed to modeled values.

We calculated a balance factor for each sunscreen as the ratio of the UVA Protection Factor (UVA-PF) for persistent pigment darkening, to the SPF value listed on product labels.

Using this method, a score was assigned to each product:Ratio of UVA-PF/SPF

>90% >66% >33% >29% >25% >21% >16% >14% >11% <=11%

UVA/UVA Bal-ance Score

0 1 2 3 4 5 6 7 8 9


Evaluating products’ effectiveness for UVB protection

We based our evaluation of UVB protection on each product’s SPF (Sun Protection Factor), which is the accepted metric for evaluating UVB protectiveness. We scaled the SPF factor to create a UVB rating for each product that ranged from 0 (effective) to 10 (ineffective). This calculation involved the following:

We set a linear relationship between SPF and a product’s UVB rating using two pre-established points on the line, defining a UVB rating of 1 (effective) to SPF 30 products, and a UVB rating of 6.4 to SPF 15 products (moderately effective). These points were set to correspond to the 3 standard score ranges we have established in our personal care product rating systems used in this sunscreen analysis as well as in our Skin Deep personal care product assessment guide.

About SPF and sunburnSunscreens were originally developed to protect humans against the immediate effects of sunburn. The Sun Protection Factor (SPF) is a measure of the protection of skin from sunburn that compares the amount of UV exposure required for a sunburn to develop with and without a sunblock (FDA 1999). Sunscreen SPF labels are obtained by testing products on human volunteers (Steinberg 2005).

Sunburned cells will begin forming 16-24 hours after 10-20 minutes of UVB exposure at peak sun intensity (Chatelain and Gabard 2001). SPF is a measure of the extra solar exposure that can reach your skin before these sunburned cells begin forming. Controlling for the variation in solar intensity over the day an SPF 30 product would prevent sunburn cells from forming following 300-600 minutes of UVB light exposure on most human skin types.

Our standard 3-tiered scoring system maps integer scores from 0 to 10 into the following 3 categories: 0-2 (low hazard or effective); 3-6 (moderate concern or moderate effectiveness); and 7-10 (higher concern or ineffective). A value of 5 was selected for SPF 15 products to correspond to the moderate score range. This effectively sets SPF 15 at the middle of the “moderate” score range with lower SPF values <15 getting higher hazard score because they are generally not recommended by health authorities for sun protection (e.g., AAD 2006).

With this linear relationship established between the UVB rating and SPF, we then calculated scores for the full range of SPF values on products using the following procedure:

We calculated UVB ratings for products with SPF values from 0 to 40 and by interpolating or • extrapolating along the line described above.We set the UVB rating at zero (effective) for products with SPF values of “40+” or with listed • SPF values exceeding 40.


SPF % UVB spectrum blocked UVB hazard score

40 98 0

30 97 1

15 93 5

8 88 6.4

4 75 7.2

Ingredient Stability

Absorption of UV light causes many sunscreen active ingredients to undergo chemical reactions or structural changes on the skin. In most cases, these ingredients quickly return to their original form to absorb more energy. However, ingredients can also degrade and may lose their UV protectiveness. In fact, a study by Shaath found that 7 out of 14 common sunscreens in Europe photodegraded significantly after exposure to UV radiation, specifically UVA radiation (Shaath, Fares et al. 1990).In certain cases, the degradation may also produce other chemicals that are toxic to the skin and body cells, especially if the sunscreen has been absorbed into the skin (Gasparro 1997) or the reactions can speed up (catalyze) the degradation of other ingredients in the sunscreen mixture (Bonda 2005).

Ideally, we’d know laboratory results of photodegradation for each active ingredient in every sunscreen product. Since this information is not publicly available and such testing is not required of manufacturers, a large number of studies from different sources needed to be analyzed. In quantifying these studies, it is difficult to compare results between different studies because different experimental conditions were used (solvent versus sunscreen formulation; measurement of light energy; sample preparation). Additionally, the degradation rate of an ingredient in a dilute laboratory solvent (such as water or ethanol) may or may not be representative of the results during consumer use. Even results in one sunscreen formulation may not be representative of the results in another because of the way different actives behave in different environments.

EWG performed linear regression analysis of percent degradation versus minimal erythmal dose (MED) exposures on solvent and sunscreen formulations. The regression equations for solvent and sunscreen systems were then weighted equally and classified into 3 categories:

Stability ClassificationExtent of Photodegradation after 2 hours of peak intensity sun exposure (10 MEDs)

Major Photodegradation over 25% breakdownMinor Photodegradation 5% to 25% breakdownNo Photodegradation (Photostable) less than 5% breakdown

We weighted solvent and formulation results equally because of the wide variation in test conditions and the possibilities that a single sunscreen formulation may not be representative of other sunscreen formulations.


There is insufficient information in the literature on the subject of photostability to reliably guide a sunscreen formulator, let alone the consumer. Our classifications are presented here:

Active Ingredient Classification PercentDegradation with exposure to 10 MEDs

4-Methylbenzylidine Camphor (4-MBC) (Deflandre and Lang 1988; Vanquerp, Rodriguez et al. 1999)

None Less than 1

Avobenzone (Parsol 1789 | Butyl Methoxydibenzoylmethane) (Deflandre and Lang 1988; Shaath, Fares et al. 1990; Roscher, Lindemann et al. 1994; Schwack and Rudolph 1995)

Major 42.1

Ensulizole (Phenylbenzimidazole Sulfonic Acid) (Deflandre and Lang 1988; Serpone, Salinaro et al. 2002) — Deflandre et al. found insignificant degradation in a sunscreen formulation; Serpone et al. measured fast degradation in various solvents.

Major 46.6

Homosalate (Berset, Gonzenbach et al. 1996; Herzog, Mongiat et al. 2002)

Minor 6.7 – 60

Menthyl Anthranilate (Beeby and Jones 2000) None No degradation

Mexoryl SX (TDSA) (Deflandre and Lang 1988; Cantrell, Mc-Garvey et al. 1999; Herzog, Hueglin et al. 2005)

Minor 21.2

Micronized Titanium Dioxide (Schlossman and Shao 2005) None No degradation

Micronized Zinc Oxide (Schlossman and Shao 2005) None No degradation

Octinoxate (Octyl Methoxycinnamate) (Deflandre and Lang 1988; Shaath, Fares et al. 1990; Berset, Gonzenbach et al. 1996; Chatelain and Gabard 2001; Serpone, Salinaro et al. 2002)

Minor 24.8

Octisalate (Octyl Salicylate) (Shaath, Fares et al. 1990; Bonda 2005)

None 3.3

Octocrylene (Shaath, Fares et al. 1990; Bonda 2005) None 1.6

Oxybenzone (Benzophenone-3) (Deflandre and Lang 1988; Shaath, Fares et al. 1990; Roscher, Lindemann et al. 1994; Berset, Gonzenbach et al. 1996; Chatelain and Gabard 2001; Serpone, Salinaro et al. 2002)

Minor 21.9

Padimate O (Octyl Dimethyl PABA | PABA Ester) (Deflandre and Lang 1988; Serpone, Salinaro et al. 2002)

Major 44.7

Sulisobenzone (Benzophenone-4) (CIR 2006) None No degradation expected

Tinosorb M (MBBT) (Herzog, Mongiat et al. 2002; Herzog, Hueglin et al. 2005)

None 1

Tinosorb S (BEMT) (Chatelain and Gabard 2001; Bonda 2005; Damiani, Baschong et al. 2007)

None 1

In order to account for a situation where an individual ingredient may photodegrade, but the sunscreen itself continues to provide significant protection relative to its original level due to the presence of other active ingredients, we assume that the UV blocking effectiveness of an active ingredient experiencing major degradation is reduced by 50%, and the UV blocking effectiveness of an active ingredient with minor degradation is reduced by 25%.


We then re-integrate over the entire spectrum and compare the degraded spectrum to the original. UVA and UVB protection are weighted equally. Based on the amount of relative degradation, the following scores are applied separately to the UVA and UVB portions:

% blocking remaining after 10 MED (approximately 2 hours of sun exposure)

Score

% Area >90% 080 < % Area< 90% 170% < % Area< 80% 260% < % Area< 70% 3% Area <60% 4

Menthyl Anthranilate and Padimate O fluoresce when exposed to sunlight, meaning they absorb in energy in the UVB range, and re-emit it in the UVA range. If an active ingredient fluoresces, we increase the stability score by 1 point.

The scores for UVA, UVB and fluorescence were added together for the overall stability score, which ranges from 0 to 9, and was then scaled to a range of 0 to 10.

Several inactive ingredients help prevent sun damage through mechanisms other than blocking UV rays. For example, a variety of anti-oxidants scavenge free radicals in cells (Klein and Palefsky 2005). In some cases, claims made with these ingredients are unregulated (Klein and Palefsky 2005), while in others, the SPF itself can no longer be predicted by the sunblocking ability of the actives alone (Stanfield 2005). In the later case, consumers are misled into believing they are receiving more protection than they actually are. For these ingredients, we attenuate the UVA and UVB scores as follows:Raw Score Score Category Description

Attenuating score (improves UVB score by 10%)

Additional protection against UVB induced dam-age

anti-oxidants protect against UVB induced radiation damage

Attenuating score (improves UVA score by 10%)

Additional protection against UVA induced dam-age

anti-oxidants protect against UVA induced radiation damage

Particle size assumptions for mineral sunscreensSmall mineral particles with sizes in the nanometer range are used in sunscreens because they provide strong UV attenuation and because they are transparent when applied to the skin. Concerns for toxic effects increase as particle size decreases, due to the potential for these small particles to


absorb through the skin and bypass our bodies natural defense mechanisms.Companies are not required to label particle size information on packages, leaving regulators and the public with little information to determine the prevalence of micro- and nano-scale materials in products (FOE 2007, FDA 2007). We reviewed available information about particle size and surface coatings for sunscreen zinc oxide and titanium dioxide on company websites and product labels, as well as the results of a manufacturer’s survey conducted by Friends of the Earth . Friends of the Earth asked sunscreen manufacturers whether they use nanoparticles, and defined those as zinc or titanium particles less than 100 nm. Only 9 companies are listed as not using nanoparticles (FOE 2009).

All mineral UV blockers in sunscreen cover a distribution of sizes and the information we have seen indicates that a significant portion of the primary particles sizes are < 100nm. The largest advertised primary particle size of any manufacture is BASF zinc oxide particles which state a mean particle size of 140nm with 20% of the particles < 100nm in size (BASF 2010).We assume the following manufacturers use zinc oxide particles with a mean size > 100nm: Alba Botanica, Allergan, Avalon Organics, Black Opal, Blistex/M.D. Forte, Bullfrog, Tatoo Goo, Lavera Schwarzkopf & Henkel, Soleo Organics, Badger, EcoLani, Gaia, Kabana, Lotus Moon, Mexitan and Miessence — based on claims made on their website or claims made to Friends of the Earth (FOE 2009).

Titanium DioxideWhen the shortest dimension of the primary particle size of titanium dioxide is 15 nm it appears transparent on the skin but by 35-60nm it appears opaque (Schlossman 2006). All information we have amassed about 10 different titanium dioxide suppliers indicated primary particles sizes of 10-35nm. Without clear regulatory guidelines manufactures and product formulators can claim they are using or not using nanoparticles without providing any information to back up that claim. In our sunscreen database we assume that all UV attention grade titanium dioxide sunscreens that apply clear on the skin use titanium dioxide with a mean primary particle size of 15-35 nm in the shortest dimension.

Zinc OxideScientists estimate the maximum UVB protection provided by zinc oxide to be accomplished with particles sizes of 20 to 30nm, and the typical sizes of zinc particles in sunscreen to be 30 to 200 nm (BASF 2010, Cross 2007, Nohynek 2007, Stamatakis 1990). Smaller particles provide less balanced UVA-UVB protection but higher SPF per percent active (Schlossman 2006) and particles larger than about 200-300 nm tint the skin white, and are unacceptable to most consumers.(BASF 2000)In our efficacy calculations we utilize two different Zinc Oxide particles sizes to reflect the larger range of mineral sizes used in sunscreen. By default EWG has assumed that zinc oxide used as an active ingredient in sunscreen has 40-60nm mean primary particle size and when the manufacture indicates they use Z-Cote or non-nano minerals we assume a mean primary particle size of 140 nm.


Titanium Dioxide Suppliers and Products

Supplier Product Crystal form Primary particle size Surface coating Source

BASF T-Lite SF-S Rutile30 nm*60 nm*10 nm, may aggregate into larger particles

Methicone Gamer 2006

BASF T-LITE SF Rutile30 nm*60 nm*10 nm, may aggregate into larger particles

Silica, Methicone Gamer 2006

BASF Uvinul TiO275% anatase/25% rutile

21 nm, agglomerate to 100 nm

trimethoxyoctysilyl BASF 2006

Degussa P-25 Anatase 21 nmNone, trimethyloctyl-silane

Mavon 2007

EMD, Rona/Merck Eusolex T-2000 Anatase10 to 20 * 100 nm (possibly due to ag-glomeration)

Alumina, Dimethi-cone

NanoDerm 2007, SCCP 2000

EMD, Rona/Merck Eusolex T-45D Anatase 10-15 nmAlumina/simethicone, oil dispersion

Sayre 2000

EMD, Rona/Merck Eusolex T-AQUA Anatase 10-15 nmAlumina, water dis-persion

Sayre 2000

ISK TTO S-4 Rutile 15 nm AHSA Schlossman 2005

ISK TTO S-3 Rutile 15 nm Alumina Schlossman 2005

ISK TTO V-3 Rutile 10 nm Alumina Schlossman 2005

Kemira UV Titan M170 Rutile 14 nm Alumina, Methicone Schlossman 2005

Kemira UV Titan M262 Rutile 20 nmAlumina, Dimethi-cone

SCCP 2000

Kobo Products TEL-100

At least one dimen-sion >100 nm, particles >100 when dispersed in ester

Aluminum hydroxide and sillica

Kobo 2009

Kobo Products MPT-154-NJE8At least one dimen-sion >100 nm

Alumina and jojoba esters

Kobo 2009

Kobo Products TTO-NJE8At least one dimen-sion >100 nm

Alumina and jojoba esters

Kobo 2009

Sachtleben Hombitec L5 Anataseest. 15 nm (80-160 m2/g)

Silica, Silicone Schlossman 2005

Showa Denka Maxlight TS-04 35 nm Silica Schlossman 2005

Tayca MT-100T Rutile 15 nm AS/AH SCCP 2000

Tayca MT-500B Rutile 35 nm Alumina Schlossman 2005

Tayca MT-100Z Rutile 15 nm AS/AH Schlossman 2005

Titan Kogyo Stt 65C-S Anatase est. 20 nm (64 m2/g) None Schlossman 2005

Zinc Oxide Suppliers and Products

Supplier Product Primary particle size Surface coating Source

Antria/Dow Zinclear25 nm, >1 um when dispersed

Stearic acidSchlossman 2005, Amer-ichol 2009

BASF Z-Cote 80 nm (30 to 200 nm) uncoated or dimethicone BASF 2006

Elementis Nanox 200 60 nm (17 m2/g) None Schlossman 2005

Kobo Products ZnO-C-12At least one dimension >100 nm

Isopropyl Titanium Tri-isostearate

Kobo 2009


Kobo Products ZnO-C-11S4At least one dimension >100 nm

Triethoxycaprylysilane Kobo 2009

Kobo Products ZnO-C-NJE3At least one dimension >100 nm

Jojoba esters Kobo 2009

Kobo Products ZnO-C-DMC2At least one dimension >100 nm

Diemethicone/Methicone Copolymer

Kobo 2009

Sakai Finex, SF-20 60 nm (20 m2/g) None Schlossman 2005

Showa Denka ZS-032 31 nm Silica Schlossman 2005

Sumitomo Cement ZnO-350 35 nm None Schlossman 2005

Tayca MZ-700 10-20 nm None Schlossman 2005



Safety Assessment (Hazard Score)

EWG’s health hazard scores were based upon the ingredient health hazard scoring system from our Skin Deep database (www.cosmeticdatabase.com). This core database of chemical hazards, regulatory status, and study availability pools the data of nearly 60 databases and sources from government agencies, industry panels, academic institutions, or other credible bodies. The information in Skin Deep is used to create hazard ratings and data gap ratings for personal care products, as well as for individual ingredients.

We have given additional weight in our calculated hazard scores for properties of particular concern for sunscreens, including for products that contain oxybenzone or vitamin A, products in a spray or powder form that may pose risk when inhaled, and products listing SPF values exceeding “SPF 50+,” the limit proposed by FDA in their 2007 draft sunscreen rule (FDA 2007). For sunscreens with a single significant concern, we assigned a rating of no lower than 3 (moderate hazard), and for sunscreens with two or more significant concerns, we assigned a rating of no lower than 7 to reflect a higher level of concern for these products.

Health hazard scores in our sunscreen evaluations reflect hazards specific to sunscreens, as well as beneficial or potentially harmful effects of specific combinations of active ingredients. We assessed hazards identified by government, industry, and academic sources, and did not evaluate specific claims made by individual manufacturers.

This report includes a closer look at the 17 chemicals permitted by FDA for use as active ingredients in sunscreen (including the various sizes of inorganic sunscreens), and the 52 chemicals used in other countries to prevent UV exposure and added to U.S. sunscreens for another purpose. We compiled relevant information from sources that included published reports in the peer-reviewed literature and risk assessments from the European Union, Japan, and Australia, countries with robust sunscreen regulations.


Assessing known or suspected chemical hazards

Sunscreens sold in the U.S. are considered over-the-counter (OTC) drug products. They contain active ingredients that must undergo safety and effectiveness testing and inactive ingredients that, like virtually all other personal care product ingredients, are not required to be tested for safety before they are sold. We used different approaches to evaluate active and inactive ingredients.

Active ingredient assessments, as well as assessments of specific active ingredient combinations, were evaluated by conducting an extensive review of the scientific literature. The review included peer-reviewed literature, filed and approved patents, and reviews by government and industry panels, as well as cross-checks with the existing Skin Deep databases. Certain inactive ingredients, such as those that are approved as active ingredients outside the U.S., are also treated as active ingredients for the health and sun hazard reviews.

Inactive ingredient assessments were conducted using the existing Skin Deep system mentioned above (EWG 2007). Skin Deep identifies chemicals with health hazards including known and probable carcinogens, reproductive and developmental toxicants, neurotoxic and immunotoxic chemicals, chemicals flagged for their persistence, bioaccumulation, and toxicity, and chemicals banned or restricted in other countries. Skin Deep assessments also highlight the extensive data gaps for the majority of ingredients used in cosmetics and personal care products.

Briefly, hazard ratings are a synthesis of known and suspected hazards associated with ingredients and products. Hazard ratings within Skin Deep are shown as low, moderate, or higher concern categories, with numeric rankings spanning those categories that range from 0 (low concern) to 10 (higher concern). Data gap ratings describe the extent to which ingredients or products have been definitively assessed for their safety. Data gap ratings are represented within Skin Deep by a numeric percentage ranging from 100% (complete absence of safety data) to 0% (comprehensive safety data).Further details concerning this methodology may be found on the Skin Deep website (www.cosmeticsdatabase.com).

References

AAD. 2002. AAD Sunscreen Monograph Letter. (Lim HW, ed). Washington, DC: American Academy of Dermatology Association.Agin PP, Cole CA, Corbett C, Sanzare CM, Marenus K, Tedeschi JP, et al. 2005. Balancing UV-A and UV-B Protection in Sunscreen Products: Proportionality, Quantitative Measurement of Efficacy, and Clear Communication to Consumers. In: Sunscreens: Regulations and Comericial Development (Shaath NA, ed). New York: Taylor and Francis, 807 – 25.


Anders A, Altheide HJ, Knalmann M, Tronnier H. 1995. Action spectrum for erythema in humans investigated with dye lasers. Photochem Photobiol 61(2): 200-5.BASF 2000. Z-Cote microfine zinc oxide Available: http://www.solsunguard.com/zcote_brochure.pdf [accessed 5/15/2010]BASF 2009. Technical Information UV filters. BASF The Chemical Company. Available: http://www.personal-care.basf.com/pdf/Statements/Technical%20Informations/EN/Cosmetic%20Ingredients/04_050103e_UV%20filters.pdf [accessed May 17, 2010].BASF 2010. Z-COTE Grades – Statement on Particle Size Distribution and Safety. 3/30/2010.Beeby A, Jones AE. 2000. The photophysical properties of menthyl anthranilate: A UV-A sunscreen. Photochemistry and Photobiology 72(1): 10-15.Berset G, Gonzenbach H, Christ R, Martin R, Deflandre A, Mascotte R, et al. 1996. Proposed protocol for determination of photostability. Part I: Cosmetic UV-Filters. Int J Cosmet Sci 18: 167-77.Bonda CA. 2005. The Photostability of Organic Sunscreen Actives: A Review. In: Sunscreens: Regulations and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis.Cantrell A, McGarvey D, Mulroy L, Truscott T. 1999. Laser flash photolysis studies of the UVA sunscreen Mexoryl SX. Photochem Photobiol 70: 292-97.Chatelain E, Gabard B. 2001. Photostabilization of butyl methoxydibenzoylmethane (Avobenzone) and ethylhexyl methoxycinnamate by bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), a new UV broadband filter. Photochemistry and Photobiology 74(3): 401-06.CIR. 2006. 2006 CIR Compendium. Washington: Cosmetic Ingredient Review.Cole CA, Forbes, P.D. 1986. An action spectrum for UV photocarcinogenesis. Photochem Photobiol 43(3): 275-84.Cross SE, Innes B, Roberts MS, Tsuzuki T, Robertson TA, McCormick P. 2007. Human Skin Penetration of Sunscreen Nanoparticles: In-vitro Assessment of a Novel Micronized Zinc Oxide Formulation. Skin Pharmacol Physiol 20(3): 148-154.CTFA/NDMA. 1996. CTFA/NDMA Taskforce Report on Critical Wavelength Determination for the Evaluation of of the UVA Efficacy of Sunscreen Products: Cosmetics, Toiletry, and Fragrance Association.Damiani E, Baschong W, Greci L. 2007. UV-Filter combinations under UV-A exposure: Concomitant quantification of over-all spectral stability and molecular integrity. J Photochem Photobiol B 87(2): 95-104.Deflandre A, Lang G. 1988. Photostability assessment of sunscreens: benzylidene camphor and dibenzoylmethane derivatives. Int J Cosmet Sci 10: 53-62.Diffey, B. 2009. Spectral uniformity: a new index of broad spectrum (UVA) protection. International Journal of Cosmetic Science 31(1): 63-68.EWG. 2007. Skin Deep. Available: http://www.ewg.org/reports/skindeep [accessed June 7 2007].EWG. 2010. Unpublished test results.FDA. 1999. Final Rule for Sunscreen Drug Products for Over-the-Counter Human Use. Federal


Register: U. S. Food and Drug Administration, 27666.Ferrero L, Pissavini M, Marguerie S, Zastrow L. 2003. Efficiency of a continuous height distribution model of sunscreen film geometry to predict a realistic sun protection factor. J. Cosmet. Sci. 54; 463 – 481.FOE. 2009. Nanotechnology and Sunscreens: A Consumer Guide for Avoiding Nano-Sunscreens. Friends of the Earth http://www.foe.org/healthy-people/nanotechnology-and-sunscreens, last updated 3/20/09.Gasparro F. 1997. Sunscreen Photobiology: Molecular, Cellular, and Physiological Aspects. New York: Springer.Gontier E, Habchi C, Pouthier T, Aguer P, Barberet P, Barbotteau Y, et al. 2004. Nuclear microscopy and electron microscopy studies of percutaneous penetration of nanoparticles in mammalian skin. 34th EDSR meeting Abstract 64.Gottbrath S, Muller-Goymann CC. 2003. Penetration and visualization of titanium dioxide microparticles in human stratum corneum – effect of different formulations on the penetration of titanium dioxide. SÖFW Journal 129(3): 11-17.Herzog B. 2002. Prediction of sun protection factors by calculation of transmissions with a calibrated step film model. Journal of Cosmetic Science 53(1): 11-26.Herzog B. 2005. Prediction of Sun Protection Factors and UV-A Parameters. In: Sunscreens: Regulations and Commercial Development (Shaath NA, ed). New York: Taylor and Francis Group, 954.Herzog B. 2006. Ciba Sunscreen Simulator. Available: http://www.cibasc.com/pccibasunscreensimulator [accessed July 20 2006].Herzog B, Hueglin D, Osterwalder U. 2005. New Sunscreen Actives. In: Sunscreens: Regulations and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis.Herzog B, Mongiat S, Dehayes C, Neuhaus M, Sommer K, Mantler A. 2002. In vivo and in vitro assessment of UVA protection by sunscreen formulations containing either butyl methoxy dibenzoyl methane, methylene bis-benzotriazoyl tetramethybutylphenol, or microfine ZnO. Int J Cosmet Sci 24: 170-85.Inbaraj J, Bilski P, Chignell C. 2002. Photophysical and photochemical studies of 2-phenylbenzimadazole and UVB sunscreen2-phenylbenzimidazole-5-sulfonic acid. Photochem Photobiol 75(2): 107-16.Klein K, Palefsky I. 2005. Formulating Sunscreen Products. In: Sunscreens: Regulations and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis.Krishnan R, Carr A, Blair E, Nordlund T. 2004. Optical spectroscopy of hydrophobic sunscreen molecules absorbed to dielectric nanospheres. Photochemistry and Photobiology 79(6): 531-39.Menzel F, Reinert T, Vogt J, Butz T. 2004. Investigations of percutaneous uptake of ultrafine TiO2 particles at the high energy ion nanoprobe LIPSION. Nuclear Instruments & Methods in Physics Research Section B-Beam Interactions with Materials and Atoms 220: 82-86.McKinlay A, Diffey B. 1987. A reference action spectrum for ultraviolet-induced erythema in human skin. CIE Journal(6): 17-22.


Nanox 2009. Nanox 200 Series. Elementis Specialties. Available: http://www.essentialingredients.com/pdf/NANOX%20200%20Brochure.pdf [accessed May 17 2010].Nohynek GJ, Lademann J, Ribaud C, Roberts MS. 2007. Grey goo on the skin? Nanotechnology, cosmetic and sunscreen safety. Crit Rev Toxicol 37(3): 251-277.Oneill JJ. 1984. Effect of Film Irregularities on Sunscreen Efficacy. Journal of Pharmaceutical Sciences 73(7): 888-91.Roscher N, Lindemann M, Kong S, Cho C, Jiang P. 1994. Photodecomposition of several compounds commonly used as sunscreen agents. J Photochem Photobiol A 80: 417-21.Sánchez C, Cuesta J. 2005. Materias Primas de Perfumería y de Cosmética. Filtros solares. Available: http://www.abacovital.com/fichastecnicas/filtros/filtros.htm [accessed June 20 2006].Schlossman D, Shao Y, 2005. Inorganic Ultraviolet Filters In: Sunscreens: Regulations and Commercial Development (Shaath NA, ed). New York: Taylor and Francis Group, 251-253.Schwack W, Rudolph T. 1995. Photochemistry of dibenzoyl methane UVA filters part I. J Photochem Photobiol B Biol 28: 229-34.Serpone N, Salinaro A, Emeline AV, Horikoshi S, Hidaka H, Zhao JC. 2002. An in vitro systematic spectroscopic examination of the photostabilities of a random set of commercial sunscreen lotions and their chemical UVB/UVA active agents. Photochemical & Photobiological Sciences 1(12): 970-81.Shaath N, Fares H, Klein K. 1990. Photodegradation of sunscreen chemicals: solvent considerations. Cosmet Toilet 105: 41-44.Shaath NA. 2005. Sunscreen Evolution. In: Sunscreens: Regulation and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis.Stamatakis P, Palmer B, Salzman G, Bohren C, Allen T. 1990. Optimum particle size of titanium dioxide and zinc oxide for attenuation of ultraviolet radiation. J Coating Technol 62(789): 95.Stanfield JW. 2005. In Vitro Techniques in Sunscreen Development. In: Sunscreens: Regulations and Comericial Development (Shaath NA, ed). New York: Taylor and Francis, 807 – 25.Steinberg DC. 2005. Regulation of Sunscreens Worldwide. In: Sunscreens: Regulations and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis.Turner P, Team GD, Stambulchik E. 2004. xmGrace Modeling Software.Vanquerp V, Rodriguez C, Coiffard C, Coiffard L, De Roeck-Holtzhauer Y. 1999. High-performance liquid chromatographic method for the comparison of the photostability of five sunscreen agents. J Chromatogr A 832: 273-77.

ReferencesAAD (American Academy of Dermatology). 2009. Position Statement on Broad Spectrum Protection of Sunscreen Products. (Amended by the Board of Directors November 14, 2009) Available: http://web1.neton-line.com/forms/policies/Uploads/PS/PS-Broad-Spectrum%20Protection%20of%20Sunscreen%20Products%2011-16-09.pdfAAD (American Academy of Dermatology). 2009. Position Statement on Vitamin D (Approved by the Board of Directors November 1, 2008) (Amended by the Board of Directors June 19, 2009). Available: www.aad.org/forms/policies/uploads/ps/ps-vitamin%20d.pdf [accessed April 6 2010].Aceituno-Madera P, Buendia-Eisman A, Arias-Santiago S, Serrano-Ortega S. Changes in the incidence of skin cancer


between 1978 and 2002. 2010. Actas Dermosifiliogr 101(1): 39-46.ACS (American Cancer Society). 2010. Skin cancer facts. Accessed May 12, 2010 at http://www.cancer.org/docroot/PED/content/ped_7_1_What_You_Need_To_Know_About_Skin_Cancer.asp.Adams JS, Hewison M. 2010. Update in vitamin D. J Clin Endocrinol Metab 95(2): 471-8.Adams LK, Lyon DY, Alvarez PJ. 2006. Comparative eco-toxicity of nanoscale TiO2, SiO2, and ZnO water suspensions. Water Research 40(19):3527-3532Adams LK, Lyon DY, McIntosh A, Alvarez PJ. 2006. Comparative toxicity of nano-scale TiO2, SiO2 and ZnO water suspensions. Water Sci Technol 54(11-12): 327-34.Agin PP, Cole CA, Corbett C, Sanzare CM, Marenus K, Tedeschi JP, et al. 2005. Balancing UV-A and UV-B Protection in Sunscreen Products: Proportionality, Quantitative Measurement of Efficacy, and Clear Communication to Consumers. In: Sunscreens: Regulations and Comericial Development (Shaath NA, ed). New York: Taylor and Francis, 807 – 25.Allen JM, Gossett CJ, Allen SK. 1996. Photochemical formation of singlet molecular oxygen in illuminated aqueous solutions of several commercially available sunscreen active ingredients. Chemical Research in Toxicology 9(3): 605-609AMA (American Medical Association). 2008. American Medical Association Complete Guide to Prevention and Wellness. John Wiley & Sons, Inc. Hoboken, NJ.Americhol. 2009. ZinCler IM Zinc Oxide Dispersions. Available at: http://www.dow.com/suncare/literature/index.htmAnders A, Altheide HJ, Knalmann M, Tronnier H. 1995. Action spectrum for erythema in humans investigated with dye lasers. Photochem Photobiol 61(2): 200-5.AP (Associated Press). 2006. Sunscreen makers sued for misleading claims; popular brands exaggerate their effectiveness, nine lawsuits charge. Associated Press April 24, 2006.Ashby J, Tinwell H, Plautz J, Twomey K, Lefevre PA. 2001. Lack of binding to isolated estrogen or androgen receptors, and inactivity in the immature rat uterotrophic assay, of the ultraviolet sunscreen filters Tinosorb M-active and Tinosorb S. Regul Toxicol Pharmacol 34, (3), 287-91.ASTM. 2006. E 2456-06. Standard Terminology Relating to Nanotechnology, ASTM International, December 2006. http://www.astm.org/Standards/E2456.htmAutier P, Dore JF, Schifflers E, Cesarini JP, Bollaerts A, Koelmel KF, et al. 1995. Melanoma and use of sunscreens: an EORTC case-control study in Germany, Belgium and France. The EORTC Melanoma Cooperative Group. Int J Cancer 61:749-55.Autier P, Dore JF. 1998. Influence of sun exposures during childhood and during adulthood on melanoma risk. EPIMEL and EORTC Melanoma Cooperative Group. European Organisation for Research and Treatment of Cancer. Int J Cancer 77:533-7.Autier P, Dore JF, Reis AC, Grivegnee A, Ollivaud L, Truchetet F, et al. 2000. Sunscreen use and intentional exposure to ultraviolet A and B radiation: a double blind randomized trial using personal dosimeters. Br J Cancer 83(9): 1243-8.Autier P, Boniol M, Severi G, Dore J-F. 2003. Quantity of sunscreen used by European students. British Journal of Dermatology 144(2): 288-291.


Autier P. 2009. Sunscreen abuse for intentional sun exposure. Br J Dermatol 161 Suppl 3: 40-5.Azurdia, Pagliaro, Diffey, Rhodes. 2001. Sunscreen application by photosensitive patients is inadequate for protection. British Journal of Dermatology 140(2): 255-258.Bakos L, Wagner M, Bakos RM, Leite CS, Sperhacke CL, Dzekaniak KS, et al. 2002. Sunburn, sunscreens, and phenotypes: some risk factors for cutaneous melanoma in southern Brazil. Int J Dermatol 41(9): 557-62.Baron ED, Stevens SR. 2002. Topical Review: sunscreens and immune protection. Br J Dermatol 146: 933-37.BASF. 2004. Press release: BASF’s Z-COTE helps make NuCelle SunSense SPF 30+ sunscreen better. http://www.basf.com/corporate/news2004/03012004.htm, [last viewed 6/30/08]BASF. 2006. Technical Information: Uvinul, T-Lite and Z-COTE grades.BASF 2009. Technical Information UV filters. BASF The Chemical Company. Available: http://www.personal-care.basf.com/pdf/Statements/Technical%20Informations/EN/Cosmetic%20Ingredients/04_050103e_UV%20filters.pdf [accessed May 17, 2010].BASF. 2010. Sunscreen Simulator: An efficient Tool to Predict UVB and UVA Protection. www.basf.com/sunscreen-simulatorBech-Thomsen N, Wulf HC. 1992. Sunbathers’ application of sunscreen is probably inadequate to obtain the sun protection factor assigned to the preparation. Photodermatol Photoimmunol Photomed 9(6): 242-4.Beeby A, Jones AE. 2000. The photophysical properties of menthyl anthranilate: A UV-A sunscreen. Photochemistry and Photobiology 72(1): 10-15.Beitner H, Norell SE, Ringborg U, Wennersten G, Mattson B. 1990. Malignant melanoma: aetiological importance of individual pigmentation and sun exposure. Br J Dermatol 122(1): 43-51.Benech-Kieffer F, Wegrich P, Schwarzenbach R, Klecak G, Weber T, Leclaire J, Schaefer H. 2000. Percutaneous absorption of sunscreens in vitro: Interspecies comparison, skin models and reproducibility aspects. Skin Pharmacology and Applied Skin Physiology 13, (6), 324-335.Benech-Kieffer F, Meuling WJ, Leclerc C, Roza L, Leclaire J, Nohynek G. 2003. Percutaneous absorption of Mexoryl SX in human volunteers: comparison with in vitro data. Skin Pharmacol Appl Skin Physiol 16, (6), 343-55.Berne B, Ros AM. 1998. 7 years experience of photopatch testing with sunscreen allergens in Sweden. Contact dermatitis 38, (2), 61-64.Berset G, Gonzenbach H, Christ R, Martin R, Deflandre A, Mascotte R, et al. 1996. Proposed protocol for determination of photostability. Part I: Cosmetic UV-Filters. Int J Cosmet Sci 18: 167-77.BfR. 2006. Frequently asked questions on nanotechnology. German Federal Institute for Risk Assessment (BfR). November 15, 2006. http://www.bfr.bund.de/cm/279/frequently_asked_questions_on_nanotechnology.pdfBikle DD. 2008. Vitamin D receptor, UVR, and skin cancer: a potential protective mechanism. J Invest Dermatol. 28(10): 2357-61.Bimczoka R, Gers-Barlagb H, Mundtb C, Kletteb E, Bielfeldtc S, Rudolphd T, Pflückerd F,


Heinriche U, Tronniere H, Johncockf W, Klebong B, Westenfeldern H, Flöbetaer-Müllerh H, Jennii K, Kockottj D, Lademannk J, Herzogl B, Rohrm M 2007. Influence of Applied Quantity of Sunscreen Products on the Sun Protection Factor – A Multicenter Study Organized by the DGK Task Force Sun Protection. Skin Pharmacology and Physiology 20(1): 57-64.Blumenthal R. 2006. Connecticut Attorney General’s Office Press Release: Attorney General Says Sunscreen Labeling Rules Fail To Prevent False Claims, Urges FDA To Update, Enforce Regulations. July 7, 2006.Boehnlein J, Sakr A, Lichtin JL, Bronaugh RL. 1994. Characterization of esterase and alcohol dehydrogenase activity in skin. Metabolism of retinyl palmitate to retinol (vitamin A) during percutaneous absorption. Pharm Res 11(8): 1155-9.Bonda CA. 2005. The Photostability of Organic Sunscreen Actives: A Review. In: Sunscreens: Regulations and Commercial Development, 3rd edition (Shaath NA, ed). Boca Raton, FL: Taylor & Francis.Borm PJ, Robbins D, Haubold S, Kuhlbusch T, Fissan H, Donaldson K, et al. 2006. The potential risks of nanomaterials: a review carried out for ECETOC. Part Fibre Toxicol 3: 11.Boyles S. FDA Wrapping Up Sunscreen Label Changes Among the Label Changes: SPF Claims of More Than 50+ Won’t Be Allowed. WebMD Health News, 5/21/2009. Accessed May 18 2010 at http://www.webmd.com/skin-problems-and-treatments/news/20090521/fda-wrapping-up-sunscreen-label-changes.Brand RM, McMahon L, Jendrzejewski JL, Charron AR. 2007. Transdermal absorption of the herbicide 2,4-dichlorophenoxyacetic acid is enhanced by both ethanol consumption and sunscreen application. Food Chem Toxicol 45(1): 93-7.Brender E, Burke A, Glass RM. 2005. Vitamin D. Journal of the American Medical Association 294(18): 2386.Brezová V, Gabčová S, Dvoranová D, Staško A. 2005. Reactive oxygen species produced upon photoexcitation of sunscreens containing titanium dioxide (an EPR study). Journal of Photochemistry and Photobiology B: Biology 79(2): 121-34.Bryden AM, Moseley H, Ibbotson SH, Chowdhury MM, Beck MH, Bourke J, et al. 2006. Photopatch testing of 1155 patients: results of the U.K. multicentre photopatch study group. Br J Dermatol 155(4): 737-47.Bucher JR. 2002. The National Toxicology Program rodent bioassay: designs, interpretations, and scientific contributions. Ann N Y Acad Sci 982: 198-207.Buser HR, Balmer ME, Schmid P, Kohler M. 2006. Occurrence of UV filters 4-methylbenzylidene camphor and octocrylene in fish from various Swiss rivers with input from wastewater treatment plants. Environ. Sci. Technol. 40(5):1427-31.Cadet J, Douki T, Ravanat JL, Di Mascio P. 2009. Sensitized formation of oxidatively generated damage to cellular DNA by UVA radiation. Photochem Photobiol Sci 8(7): 903-11.Calafat AM, Wong L.-Y, Ye X, Reidy JA., Needham LL. 2008. Concentration of the sunscreen agent, benzophenone-3, in residents of the United States: National Health and Nutrition Examination Survey 2003-2004. Environ Health Perspect 116, (7), 893-897.


Cantrell A, McGarvey D, Mulroy L, Truscott T. 1999. Laser flash photolysis studies of the UVA sunscreen Mexoryl SX. Photochem Photobiol 70: 292-97.Castle M. 2007. Press Release: Castle Urges FDA to Upgrade Sunscreen Standard to Protect All Americans from Harmful Rays Leading to Skin Cancer.Chatelain E, Gabard B. 2001. Photostabilization of butyl methoxydibenzoylmethane (Avobenzone) and ethylhexyl methoxycinnamate by bis-ethylhexyloxyphenol methoxyphenyl triazine (Tinosorb S), a new UV broadband filter. Photochemistry and Photobiology 74(3): 401-06.Chen J, Dong X, Zhao J, Tang G. 2009. In vivo acute toxicity of titanium dioxide nanoparticles to mice after intraperitioneal injection. J Appl Toxicol.Cherng SH, Xia Q, Blankenship LR, Freeman JP, Wamer WG, Howard PC, et al. 2005. Photodecomposition of retinyl palmitate in ethanol by UVA light-formation of photodecomposition products, reactive oxygen species, and lipid peroxides. Chem Res Toxicol 18(2): 129-38.CIE (Commission Internationale de l´Eclairage). 1998. Erythema Reference Action Spectrum and Standard Erythema Dose. Joint ISO/CIE Standard. ISO 17166:1999/CIE S 007-1998. Available: http://www.cie.co.at/index.php/Publications/index.php?i_ca_id=469CIR (Cosmetic Ingredient Review). 2009. CIR Compendium Containing Abstracts, Discussions, and Conclusions of CIR Cosmetic Ingredient Safety Assessments. Available: www.cir-safety.orgCole CA, Forbes, P.D. 1986. An action spectrum for UV photocarcinogenesis. Photochem Photobiol 43(3): 275-84.Consumers Union. 2007. Sunscreens: Some are short on protection. Consumer Reports 72(7): 6.Cross SE, Innes B, Roberts MS, Tsuzuki T, Robertson TA, McCormick P. 2007. Human Skin Penetration of Sunscreen Nanoparticles: In-vitro Assessment of a Novel Micronized Zinc Oxide Formulation. Skin Pharmacol Physiol 20(3): 148-154.CTFA (Cosmetic, Toiletry, and Fragrance Association). 2006. Comments of the Cosmetic, Toiletry, and Fragrance Association Regarding the Scientific and Legal Issues Associated With Nanotechnology in Personal Care Products. Comments. Washington, DC: Cosmetic, Toiletry, and Fragrance Association (CTFA).CTFA/NDMA (Cosmetic, Toiletry and Fragrance Association and Nonprescription Drug Manufacturers Association). 1996. CTFA/NDMA Taskforce Report on Critical Wavelength Determination for the Evaluation of of the UVA Efficacy of Sunscreen Products: Cosmetics, Toiletry, and Fragrance Association.Damiani E, Baschong W, Greci L. 2007. UV-Filter combinations under UV-A exposure: Concomitant quantification of over-all spectral stability and molecular integrity. J Photochem Photobiol B 87(2): 95-104.Damiani E, Baschong W, Greci L. UV-Filter combinations under UV-A exposure: Concomitant quantification of over-all spectral stability and molecular integrity. Journal of photochemistry and photobiology 2007; 87(2): 95-104.Damiani E, Astolfi P, Giesinger J, Ehlis T, Herzog B, Greci L, et al. 2010. Assessment of the photo-degradation of UV-filters and radical-induced peroxidation in cosmetic sunscreen formulations. Free


Radical Research 44(3): 304-12.Dankovic D, Kuempel E, Wheeler M. 2007. An approach to risk assessment for TiO2. Inhal Toxicol. 19 Suppl 1:205-12.Danovaro R, Bongiorni L, Corinaldesi C, Giovannelli D, Damiani E, Astolfi P, Greci L, Pusceddu A. 2008. Sunscreens cause coral bleaching by promoting viral infections. Environ Health Perspect. 116(4): 441-7.Deflandre A, Lang G. 1988. Photostability assessment of sunscreens: benzylidene camphor and dibenzoylmethane derivatives. Int J Cosmet Sci 10: 53-62.Dennis LK, Beane Freeman LE, VanBeek MJ. 2003. Sunscreen use and the risk for melanoma: a quantitative review. Ann Intern Med 139(12): 966-78.Dennis LK, Vanbeek MJ, Beane Freeman LE, Smith BJ, Dawson DV, Coughlin JA. 2008. Sunburns and risk of cutaneous melanoma: does age matter? A comprehensive meta-analysis. Ann Epidemiol 18(8): 614-27.Diffey BL. 2009a. Sunscreens as a preventative measure in melanoma: an evidence-based approach or the precautionary principle? Br J Dermatol 161 Suppl 3: 25-7.Diffey B. 2009b. Spectral uniformity: a new index of broad spectrum (UVA) protection. International Journal of Cosmetic Science 31(1): 63-68.Dodd and Reed, Hillary Clinton (D-NY), Joe Biden (D-DE), Tom Carper (D-DE), and Bernie Sanders (I-VT).Dodd C. 2007. Press Release: Dodd, Reed Lead Fight Against Skin Cancer; Request Higher Standard’s for FDA’s sunscreen labeling. (Letter to FDA from Senators.Donawho C, Wolf P. 1996. Sunburn, sunscreen, and melanoma. Curr Opin Oncol 8(2): 159-66.Dondi D, Albini A, Serpone N. 2006. Interactions between different solar UVB/UVA filters contained in commercial suncreams and consequent loss of UV protection. Photochem Photobiol Sci 5(9): 835-843.Draelos ZD. 2010. Are sunscreens safe? Journal of Cosmetic Dermatology 9: 1-2.Dubin N, Moseson M, Pasternack BS. 1986. Epidemiology of malignant melanoma: pigmentary traits, ultraviolet radiation, and the identification of high-risk populations. Recent Results Cancer Res 102: 56-75.Duell EA, Kang S, Voorhees JJ. 1997. Unoccluded retinol penetrates human skin in vivo more effectively than unoccluded retinyl palmitate or retinoic acid. J Invest Dermatol 109(3): 301-5.Dufour E, et al. 2006. Clastogenicity, photo-clastogenicity or pseudo-photo-clastogenicity: Genotoxic effects of zinc oxide in the dark, in pre-irradiated or simultaneously irradiated Chinese hamster ovary cells. Mutation Research. 607(2 ): 215-224.Dunford R, Salinaro A, Cai L, Serpone N, Horikoshi S, Hidaka H, et al. 1997. Chemical oxidation and DNA damage catalysed by inorganic sunscreen ingredients. FEBS Lett 418(1-2): 87-90.Dupuy A, Dunant A, Grob JJ. 2005. Randomized controlled trial testing the impact of high-protection sunscreens on sun-exposure behavior. Arch Dermatol 141(8): 950-6.Durrer, S.; Ehnes, C.; Fuetsch, M.; Maerkel, K.; Schlumpf, M.; Lichtensteiger, W. 2007. Estrogen sensitivity of target genes and expression of nuclear receptor co-regulators in rat prostate after


pre- and postnatal exposure to the ultraviolet filter 4-methylbenzylidene camphor. Environ Health Perspect. 115 Suppl 1, 42-50.El-Boury S, Couteau C, Boulande L, Paparis E, Coiffard LJM. 2007. Effect of the combination of organic and inorganic filters on the Sun Protection Factor (SPF) determined by in vitro method. International Journal of Pharmaceutics 340(1-2): 1-5.EPA (U.S. Environmental Protection Agency). 2005. Nanotechnology Workgroup / EPA’s Science Policy Council. Nanotechnology White Paper, 68-70, US Environmental Protection Agency. December 2, 2005. http://www.epa.gov/OSA/pdfs/EPA_nanotechnology_white_paper_external_review_draft_12-02-2005.pdEspinosa Arranz J, Sanchez Hernandez JJ, Bravo Fernandez P, Gonzalez-Baron M, Zamora Aunon P, Espinosa Arranz E, et al. 1999. Cutaneous malignant melanoma and sun exposure in Spain. Melanoma Res 9(2): 199-205.European Commission. 2006. Recommendation on the efficacy of sunscreen products and the claims made relating thereto, OJ L265, 2006 ⁄7647 ⁄EC, 39–43.EWG (Environmental Working Group). 2005. Consumer Update. FDA admits inability to ensure the safety of personal care products http://www.cosmeticsdatabase.com/research/fdafails.php: Environmental Working Group.EWG (Environmental Working Group). 2006. A Survey of Ingredients in 25,000 Personal Care Products Reveals Widespread Use of Nano-Scale Materials, Not Assessed for Safety, in Everyday Products. Comments to U.S. Food and Drug Administration. : Environmental Working Group. Available at http://ewg.org/issues/cosmetics/20061010/comments.php.EWG (Environmental Working Group). 2010. Skin Deep Cosmetic Safety Database. Available: http://www.cosmeticdatabase.com.EWG (Environmental Working Group). 2010. Unpublished test results.Faass O, Schlumpf M, Reolon S, Henseler M, Maerkel K, Durrer S. 2009. Lichtensteiger, W., Female sexual behavior, estrous cycle and gene expression in sexually dimorphic brain regions after pre- and postnatal exposure to endocrine active UV filters. Neurotoxicology, 30, (2), 249-60.Faurschou A, Wulf H.C., 2007. The relation between sun protection factor and amount of suncreen applied in vivo. British Journal of Dermatology 156(4): 716-719.FDA (U.S. Food and Drug Administration). 1996. Sunscreen Drug Products for Over-the-Counter Human Use; Amendment to the Tentative Final Monograph. Federal Register 61(180): 48645-48655.FDA (U.S. Food and Drug Administration). 1999. Final Rule for Sunscreen Drug Products for Over-the-Counter Human Use. Federal Register: U. S. Food and Drug Administration, 27666.FDA (U.S. Food and Drug Administration). 2000. Summary: Cosmetics Harmonization and International Cooperation (CHIC) Meeting; Washington, D.C.; May 8-9, 2000. Available: http://www.cfsan.fda.gov/~dms/cos-ch00.html.FDA (U.S. Food and Drug Administration). 2006. Center for Drug Evaluation and Research Application Number 21-502: Medical Review, Center for Drug Evaluation and Research, Food and Drug Administration. In 2006; pp July 11, 2006.FDA (U.S. Food and Drug Administration). 2006a. Prescription Drug User Fee Rates for Fiscal Year


2007. Federal Register 71(148): 43780-43784.FDA (U.S. Food and Drug Administration). 2006b. Monograph History. Available: www.fda.gov/cder/Offices/OTC/Monograph_history_sunscreen.pdf [accessed May 31 2007].FDA (U.S. Food and Drug Administration). 2007. Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph; Proposed Rule. In: 21 CFR Parts 347 and 352. Federal Register: U. S. Food and Drug Administration. Available at http://www.fda.gov/OHRMS/DOCKETS/98fr/07-4131.htm.FDA (U.S. Food and Drug Administration). 2009a. About the National Center for Toxicological Research. Biochemical Toxicology. Available: http://www.fda.gov/AboutFDA/CentersOffices/NCTR/WhatWeDo/ResearchDivisions/ucm078482.htmFDA (U.S. Food and Drug Administration). 2009b. FDA and Nanotechnology Products–Frequently Asked Questions. Available: http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/FrequentlyAskedQuestions/default.htm [accessed 6/24/09].Felix T, Hall B. J, Brodbelt JS. 1998. Determination of benzophenone-3 and metabolites in water and human urine by solid-phase microextraction and quadrupole ion trap GC-MS. Analytica Chimica Acta, 371, (2-3), 195-203.Fielding JE, Teutsch SM. 2010. Skin Cancer Prevention: Sunnyside Up or Scrambled? J Natl Cancer Inst: in press.FOE (Friends of the Earth). 2009. Nanotechnology and Sunscreens: A Consumer Guide for Avoiding Nano-Sunscreens. http://www.foe.org/healthy-people/nanotechnology-and-sunscreens, last updated 3/20/09.Fourtanier A, Moyal D, Seite S. 2008. Sunscreens containing the broad-spectrum UVA absorber, Mexoryl SX, prevent the cutaneous detrimental effects of UV exposure: a review of clinical study results. Photodermatol Photoimmunol Photomed 24(4): 164-74.Franklin NM, Rogers NJ, Apte SC et al. 2007. Comparative toxicity of nanoparticulate ZnO, bulk ZnO, and ZnCl2 to a freshwater microalga (Pseudokirchneriella subcapitata): the importance of particle solubility. Environ Sci Technol 41 (24):8484-90FTC (Federal Trade Commission). 1997. Federal Trade Commission complaint against Schering-Plough Healthcare Products, Inc. May 16, 1997. Docket No. C-3741.Fu PP, Howard PC, Culp SG, Xia Q, Webb PJ, Blankenship LR, et al. 2002. Do topically applied skin creams containing retinyl palmitate affect the photocarcinogenicity of simulated solar light? J Food Drug Anal 10: 262-68.Fu PP, Cheng SH, Coop L, Xia Q, Culp SJ, Tolleson WH, et al. 2003. Photoreaction, phototoxicity, and photocarcinogenicity of retinoids. J Environ Sci Health C Environ Carcinog Ecotoxicol Rev 21(2): 165-97.Fu PP, Xia Q, Yin JJ, Cherng SH, Yan J, Mei N, et al. 2007. Photodecomposition of vitamin A and photobiological implications for the skin. Photochem Photobiol 83(2): 409-24.Gamer AO, Leibold E, van Ravenzwaay B. 2006. The in vitro absorption of microfine zinc oxide and titanium dioxide through porcine skin. Toxicol In Vitro 20(3): 301-7.Garland CF, Garland FC, Gorham ED. 2003. Epidemiologic evidence for different roles of

ewg’s 2010 sunscreen guide -...

Documents