In its 2010 sunscreen report, the Environmental Working Group smears the vast majority of products on the market and takes special issue with those containing vitamin A compound retinyl palmitate, which may increase the risk of skin cancer when exposed to sun, the organization says.

Found in 41 percent of sunscreens, retinyl palmitate may be photocarcinogenic, "meaning that in the presence of the sun's ultraviolet rays, the compound and skin undergo complex biochemical changes resulting in cancer," EWG says.

In a statement, Personal Care Products Council Chief Scientist John Bailey calls EWG's assertions "baseless."

"EWG has inappropriately taken preliminary retinyl palmitate data from the [National Toxicology Program's] website to support their conclusions that products containing retinyl palmitate, including sunscreens, may not be safe," he says.

Retinyl palmitate has "been used safely in various cosmetic preparations, including sunscreen products, for years," Bailey says, noting that the ingredient is approved by FDA for use as a food additive and OTC drug ingredient, and the Cosmetic Ingredient Review has deemed it safe for use in cosmetics.

EWG's position on retinyl palmitate is based on an NTP study being conducted to explore retinyl palmitate's "potential to enhance UV radiation-induced photocarcinogenicity."

According to Bailey, the study was not designed to evaluate the ingredient in sunscreen formulations.

NTP has released its preliminary data for a scientific peer review. Bailey noted that FDA cannot assess the findings until the peer review has concluded.

"Certainly, no credible scientific organization would ever evaluate such preliminary data and make recommendations based upon it," he says.

EWG Senior Analyst Sonya Lunder disagrees. "We feel comfortable [with the data] and we also know that [NTP and FDA have] published 15 other studies along the way highlighting damage or concerns about the retinol family," she told "The Rose Sheet" May 26.

According to EWG's report, its scientists independently assessed available data and found that "even the lowest concentration of retinyl palmitate tested (0.1%) was associated with increased growth rates of skin tumors and lesions."

In a May 28 letter, EWG urges FDA Commissioner Margaret Hamburg and NTP and National Institute of Environmental Health Sciences Director Linda Birnbaum to quickly make public a final assessment on the photocarcinogenicity of retinyl palmitate.

EWG expects that FDA and NTP will publish their final words on retinyl palmitate in December. In the meantime, the watchdog advises consumers to choose sunscreens that are free of the ingredient.

It also recommends that consumers avoid sunscreen products containing oxybenzone, products containing nanoparticles and those in spray or powder forms.

Group Gives Nod To Just 8% Of Products

Overall, EWG vouches for just 8 percent of the 500 sunscreen products it analyzed.

It says a "surge in exaggerated SPF claims," as well as the use of possibly hazardous ingredients, contributed to the low number of high marks. The group ranks products on a scale of 1 to 10 based on their ingredients, the UVA and UVB protection they offer and their stability, among other factors.

EWG comes down hard on products with SPF values over 50. "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 ... and subject their skin to large amounts of UVA radiation," the group says.

While UVB radiation may be responsible for sunburns and most cancers, UVA radiation is believed to exacerbate UVB effects and has been linked to some melanomas. SPF values generally indicate just a product's UVB protective capacity.

EWG submits that a product labeled SPF 100 actually performs more like SPF 3.2 because consumers - either due to ignorance or overconfidence - do not apply the sunscreen adequately or often enough.

"People are sold products that overstate their value," Lunder said. "[They] have a non-realistic expectation of how sunscreen works, how much protection they're offered, and we see huge problems with compliance - in terms of how much people apply and how frequently - as well as [with] understanding that the SPF is only a measure of sunburn protection and not a measure of total sun protection."

Sunscreens from Badger , California Baby , Jason Naturals and Soleo Organics received top marks from EWG.

On the other end of the spectrum, EWG has compiled a "Hall of Shame" - a list that "typif[ies] what's wrong with the sun-protection business" - singling out products including Banana Boat Baby Max Protect SPF 100, iS Clinical SPF 20 Powder, Aveeno Baby Continuous Protection SPF 55 and Panama Jack Naturals Baby Sunblock SPF 50.

The Council says EWG "invents" its own sunscreen product rating system. "EWG's methodology for calculating SPF values has been proven to be inaccurate and unreliable," Bailey says.

He observes that visitors to EWG's website can buy recommended sunscreen products through retailer links. The purchases support EWG, "which demonstrates a vested commercial interest," Bailey suggests.

EWG Acts In Absence Of Final Monograph

Part of the impetus behind EWG's report was to encourage FDA to issue its final sunscreen monograph, which has been "promised since 1978," the group says. The agency is included on EWG's "shame" list.

"Industry's lackluster performance and [FDA's] failure to issue regulations for sunscreens lead EWG to warn consumers not to depend on sunscreen for primary protection from the sun's harmful ultraviolet rays," EWG says.

According to the Department of Health and Human Services' semi-annual regulatory agenda, FDA now aims to issue its final sunscreen monograph in October (¹ Also see "With Summer In Sight, FDA Pushes Final Sunscreen Rule To Fall" - HBW Insight, 3 May, 2010.).

EWG is urging consumers to speak up and put pressure on FDA to finalize the monograph, according to Lunder. "This is something that consumers are aware of and really demanding," she said.

The draft rule includes new testing standards for marketers making UVA protection claims, as well as a 4-star system for denoting the level of UVA protection afforded (² Also see "Sunscreen Proposed Rule May Create UVA Protection Marketing Opportunity" - HBW Insight, 27 August, 2007.).

If the final rule is released in October, "we are also concerned that they're talking about a 12-18 month phase-in, which could potentially be two more summers of really inadequate products on the market or inadequate distinction between products on the market," Lunder said.

In the Council's release, Bailey defends FDA's delay in issuing the monograph. "We support FDA's commitment to making decisions based on sound science," he says. "Finalizing sunscreen safety standards is a complex regulatory undertaking that requires the careful application of scientific principles and consideration of the evolving science and thousands of data submissions."

Meanwhile, the Council is "deeply concerned" that EWG's report "will cause consumers to avoid using sunscreens on themselves and their children," Bailey said. "Consumers can be confident" that sunscreens protect from harmful effects of the sun and that safety and efficacy of sunscreens "remains the highest priority" for manufacturers, he says.

The American Academy of Dermatology also has weighed in, recommending that consumers use sunscreen as directed on product labels. "Scientific evidence supports the beneficial effects of sunscreen usage when used as one component of a daily photoprotection regimen," President William James notes in a statement.

"Sunscreen is an important tool in the fight against skin cancer," the doctor continues, recommending that consumers generously apply water-resistant, broad-spectrum SPF 30 sunscreen, wear protective clothing and stay in the shade.

In December, the Academy phased out its seal of approval for sunscreens in anticipation of FDA's final rule (³ Also see "Dermatologists Expect FDA Sunscreen Rule "Soon," End Product Seal Program" - HBW Insight, 7 December, 2009.). James says that until the final monograph launches, the Academy "will continue to monitor scientific evidence in this area."

In its sunscreen report, EWG also shames the Skin Cancer Foundation, suggesting that requirements for its seal of approval are not strict enough.

- Lauren Nardella ( ⁴ l.nardella@elsevier.com )

EWG Advises Against Vitamin A Compound, More Than 90% Of Sunscreens

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