Most U.S. Sunscreens Not So Hot, Reflecting FDA Failures – EWG

Sunscreen products earned low marks in EWG’s 2013 guide because FDA’s regulation of the category is not rigorous enough, the group says. But the Personal Care Products Council cautions that consumers may get the wrong message from EWG and choose to not use sunscreen.

FDA needs to improve its standards for sunscreens, which allow hazardous products to remain on the market, the Environmental Working Group says.

For the seventh edition of its annual Sunscreen Guide, EWG evaluated more than 1,400 sunscreens, moisturizers, lip and makeup products with sun protection claims and found that just 25% offer adequate protection and pose few or no safety concerns.

In rating products, the organization accounted for various factors contributing to product efficacy, including UVA protection, balance of UVA/UVB protection and sunscreen stability, as well as perceived health hazards.

Sunscreen formulas continue to fall short on safety, an area where FDA oversight is not helping, EWG suggests.

The activist group is leery of sunscreen products containing oxybenzone to absorb UV rays, as the ingredient can disrupt hormone levels, leading to increased risk of endometriosis and lower birth weight in female infants, it says.

Oxybenzone also has been associated with allergic reactions, EWG notes.

Nearly half of all beach and sport sunscreens reviewed by EWG featured oxybenzone, and the products generally received low safety scores accordingly.

EWG also criticizes sunscreen products containing retinyl palmitate – a vitamin A compound added to sunscreens to slow skin aging or improve their aesthetic qualities. EWG notes that the ingredient has been linked to increased carcinogenic activity in rodent studies.

Industry has disputed such research as flawed, misrepresented or at minimum inconclusive. EWG repeatedly has called on FDA to prohibit the use of retinyl palmitate and oxybenzone in sunscreen products.

PCPC Critical Of Message

FDA’s final monograph for OTC sunscreen products, published in 1999, includes oxybenzone (6%) in a list of active ingredients and maximum concentrations that meet the agency’s conditions for a sunscreen product to be generally recognized as safe and effective (GRASE).

The monograph was stayed indefinitely in 2001 to allow for data collection and related rulemaking and has yet to go into effect. While FDA has elected to use “enforcement discretion” in the interim, EWG maintains that the delay amounts to a public disservice.

At the same time, the organization is issuing a potentially confusing message to consumers, asserting in its report that “most scientists and public health agencies – including the FDA itself – have found very little evidence that sunscreen prevents most types of skin cancer.”

The Personal Care Products Council suggests that that message, coupled with EWG’s attack on commonly used sunscreen ingredients, constitutes the biggest disservice.

“Despite the extensive and growing body of credible science demonstrating the safety, efficacy and health benefits of sunscreens, EWG continues to promote false and misleading assertions about sunscreen products and their ingredients. Our concern is that confusing, unsubstantiated claims could actually serve to discourage consumers from using sunscreen,” PCPC’s Farah Ahmed, who chairs the trade association’s sunscreen committee, says in a May 20 statement.

Ahmed says oxybenzone offers protection from both UVA and UVB rays. She noted regulatory authorities in Canada and Europe, as well as FDA, have approved the use of oxybenzone as a safe and effective sunscreen ingredient.

“Contrary to EWG's claims, the global safety profile for oxybenzone is comprehensive and robust, and current scientific research shows no connection between oxybenzone and endocrine or hormone disruption,” she says.

Retinyl palmitate similarly has a compelling safety record and is FDA-approved for use as a food additive, Ahmed notes.

Differences of opinion on cosmetic ingredient safety are not uncommon for PCPC and EWG.

Both groups sponsor websites designed to provide consumers with cosmetics safety information – PCPC with CosmeticsInfo.org, which offers ingredient assessments based largely on FDA positions and decisions from the Cosmetic Ingredient Review Expert Panel, and EWG with its Skin Deep site, which draws from “nearly 60 toxicity and regulatory databases.”

Whereas CosmeticsInfo.org lists propylparaben, for example, as an ingredient that has been determined safe for use in cosmetic products by CIR, Skin Deep identifies the ingredient as a “high hazard” due to a cited potential for developmental/reproductive toxicity, allergies/immunotoxicity, endocrine disruption and ecotoxicity.

The presence of propylparaben in Johnson & Johnson’s Aveeno Baby Continuous Protection Sunscreen Lotion SPF 55 contributed to the overall high hazard score (7 out of 10) given to the product in EWG’s 2013 Sunscreen Guide. The product also contains oxybenzone, which did not help it win EWG’s favor.

Other Aveeno sunscreen products fared better, including Aveeno Baby Natural Protection Face Stick SPF 50, which received a 2 (low hazard) score.

Other products flagged as representing high hazards include Panama Jack Sunscreen Oil SPF 15 because it contains oxybenzone and retinyl palmitate and offers poor UVA protection, as well as Walgreens Sheer Dry-Touch Sunscreen Lotion SPF 85 and Vichy Laboratoires Capital Soleil Soft Sheer Sunscreen Lotion SPF 60 from L’Oreal S.A., both of which feature oxybenzone and carry a “misleading SPF,” according to EWG.

FDA Allows “Dubious” Claims

In June 2011, FDA published a proposed rule to cap sunscreen SPF claims at SPF 50 or SPF 50+, citing a lack of evidence demonstrating an “additional clinical benefit” in actual use for products with higher SPF values (Also see "FDA Considers Capping SPF Values At 50+ Despite Efficacy Data" - HBW Insight, 27 Jun, 2011.).

The proposal has generated debate among industry members, with some manufacturers supporting the measure and others denouncing it as a potential blow to innovation and a disservice to consumers seeking optimal protection (Also see "P&G Backs Proposed SPF Cap For Sunscreens, In Break From Rivals" - HBW Insight, 14 Nov, 2011.).

EWG supports the proposed cap, maintaining that high-SPF products – in excess of SPF 50 – offer only “marginally better sunburn protection” while representing a poorer UVA/UVB balance and inspiring too much confidence among consumers, who are apt to stay out in the sun longer and less inclined to reapply product as needed, potentially leading to harmful overexposure to UV rays, among other concerns.

According to EWG, high-SPF products account for one in seven sunscreen products on the market, and in the absence of a final rule from FDA, consumers are being misled by claims associated with high-SPF products. In its Sunscreen Guide the group penalizes brands it sees as culprits.

EWG highlights another strain of potentially misleading sunscreen marketing claims that FDA rulemaking has actually enabled, in its view.

The group takes issue with FDA’s final rule for labeling and testing of OTC sunscreen drug products, issued in June 2011, under which firms meeting minimum SPF and broad-spectrum standards are free to advertise that their products can reduce the risk of skin cancer and early skin aging (Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - HBW Insight, 20 Jun, 2011.).

FDA “now allows most sunscreens on the American market to make dubious claims that they help lower the risk of skin cancer and sun-related skin aging,” EWG states, maintaining that available evidence does not support such an assertion.

EWG Advises Against Sprays

In addition to high-SPF products, sunscreen sprays and powders take hits in EWG’s Sunscreen Guide.

FDA has expressed concern about the safety and efficacy of sunscreen sprays and solicited industry data to study them in more depth. In a 2011 advanced notice of proposed rulemaking, the agency indicated that it is considering eliminating spray sunscreens from the OTC sunscreen monograph, along with other delivery formats including sunscreen powders, wipes, towelettes, body washes and shampoos (Also see "FDA Questions Spray Sunscreen Safety, Efficacy & Monograph Status" - HBW Insight, 27 Jun, 2011.).

Spray dosage products “lack a safety and efficacy record” comparable to other dosage forms, such as oils, lotions, creams, gels, butters, pastes, ointments and sticks, according to the ANPR.

EWG recognizes the appeal of spray sunscreens but advises against their use.

“Given the ease of applying them on squirming kids and hard-to-reach areas, these super-popular aerosolized sunscreens may seem like a dream come true,” the organization says. “But there’s growing concern that these sprays pose serious inhalation risks. They also make it too easy to apply too little or to miss a spot, leaving bare skin exposed to harmful rays.”

About one in four sunscreens in EWG’s database is a spray, the group says.

CVS Sheer Mist Sunscreen SPF 70 receives a hazard score of 7 in EWG's report due to its spray format, on top of its use of oxybenzone and vitamin A and its potentially misleading SPF integer.

Coppertone Sport Pro Series Clear Continuous Spray Sunscreen SPF 50 from Merck & Co. Inc. and Banana BoatSport Performance CoolZone Continuous Spray Sunscreen SPF 30 from [Energizer Holdings Inc.] also receive 7 ratings for their spray deliveries and oxybenzone use.

U.S. Lags Behind Europe

The highest ratings in EWG’s Sunscreen Guide generally went to natural-oriented brands with mineral-based sunscreens formulated with zinc oxide and/or titanium dioxide for UV protection (Also see "EWG Supports Nano-Engineered Mineral Sunscreens In 2013 Report" - Pink Sheet, 27 May, 2013.).

The group is less comfortable with chemical UV filters – at least those available to manufacturers in the U.S.

From EWG’s perspective, FDA has dragged its feet approving additional UV filters, including those awaiting review under time and extent applications, which can be submitted for sunscreen ingredients backed by safe-use data generated in markets abroad.

As a result, U.S. sunscreen formulators have fewer UV filters at their disposal (17), compared with firms in Europe, which can choose from 27, according to EWG.

The Public Access to SunScreens Coalition, comprising manufacturers, dermatologists and research and health care advocacy groups, suggests a user fee program to help expedite FDA review of TEAs for OTC sunscreen ingredients proposed for introduction in the U.S. While FDA receives user fees to support its work in other areas, including food safety and Rx-to-OTC switch reviews. Congress, not the agency, has authority to create user fee programs (Also see "Sunscreen Group Suggests User Fees To Expedite Ingredient Reviews" - Pink Sheet, 18 Mar, 2013.).

The most commonly used sunscreen active in the U.S. is avobenzone, which FDA approved for use in 1972. EWG says that among chemicals cleared for use in Europe, three are more effective than avobenzone – BASF SE’s Tinosorb S and Tinosorb M broad-spectrum UV absorbers, which it gained through its acquisition of Ciba Specialty Chemicals in 2008, and L’Oreal’s Mexoryl SX (ecamsule).

All three, plus L’Oreal’s next-generation Mexoryl XL (drometrizole trisiloxane), are under TEA review for possible inclusion in the FDA monograph .

EWG says more than half of the 750 beach and sport sunscreens it reviewed would not qualify for marketing in the European Union, where sunscreens must offer UVA protection that is at least one-third as potent as the SPF, the measure of the product’s ability to shield against UVB rays that burn the skin.