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Americans have fewer choices and notably poorer protection from ultraviolet A rays in their sunscreen options than Europeans. While most sunscreens prevent sunburn effectively when used correctly, they are not as good at preventing the more subtle skin damages produced by lower-energy UVA radiation. UVA rays have less energy and don’t burn the skin, but they can cause the skin to age, can suppress the immune system and can contribute to the development of melanoma.
Sunscreen manufacturers who make products for the market in Europe meet high standards for UVA protection, because they can pick and choose among seven ingredients that offer strong protection against UVA radiation. Some of these chemicals appear to offer significant performance advantages over the sunscreen chemicals the federal Food and Drug Administration permits in products sold on the American market. Only two of the FDA-approved ingredients filter UVA rays.
Between 2003 and 2010, sunscreen makers applied for FDA permission to use eight sun-filtering chemicals developed by European companies. Four of these – Tinosorb S, Tinosorb M, Mexoryl SX and Mexoryl XL – appear to be more effective than avobenzone, the most common UVA filter permitted by the FDA. The FDA’s failure to respond to these applications prompted Congress to pass the Sunscreen Innovation Act of 2014 (FDA 2014). This act requires the FDA to review new applications for sunscreen active ingredients within 300 days, but didn’t relax the standards that companies must use to prove their new ingredients are both safe and effective.
The FDA responded in 2015 that the companies involved had not submitted enough information to prove that their chemicals were, in fact, safe and effective for use in sunscreens (FDA 2015). The agency asked for more data, including complete study results, measurements of ingredient levels in people’s blood and long-term studies on systemic toxicity and potential endocrine system disruption. FDA officials have said that many chemicals now used in sunscreens that were on the market in 1978, when the FDA began to develop sunscreen rules, would not pass muster under the regulations now in force.
Some of the information the FDA wanted, such as complete copies of studies, might be easy for sunscreen makers to produce. But in other cases, the companies might need years to satisfy FDA requests.
In the meantime, Americans are being shortchanged. When its most recent round of sunscreen regulations went into effect in December 2012, the FDA set lax standards for UVA protection – in part because good UVA filtering ingredients had not been approved. Those regulations allowed nearly every sunscreen product to be marketed as “broad spectrum,” a term that implied good UVA protection, which many products don’t provide.
British researcher Brian Diffey, of the chemical company BASF, evaluated the UV protection of four U.S. sunscreens and four sold in Europe, each of which had an SPF value of 50 or 50+. He found that the U.S. sunscreens allowed, on average, three times more UVA rays to pass through to skin than European products, which included the modern UVA filters (Diffey 2015).
In the nations regulated by the European Commission, manufacturers voluntarily comply with a recommendation that all sunscreens must offer UVA protection that is at least a third as potent as the SPF, the measure of the product’s ability to shield against UVB rays that burn the skin (European Commission 2006, Colipa 2009). In other words, if a product advertises SPF 30, its UVA protection must be at least 10. EWG estimates that half of the 650 beach and sport sunscreens we assessed this year are too weak for the European market due to inadequate UVA filtering. Laboratory tests of 20 common U.S. sunscreens confirmed these findings, as only 11 of the 20 passed the European UVA test (Wang 2017).
These differences add up. Diffey and his colleague Uli Osterwalder estimate that over a two-week vacation to a tropical latitude, fair-skinned tourists could successfully prevent sunburns with a poor quality sunscreen, but at the same time receive as much UVA exposure as they would by visiting a tanning salon 10 times for eight-minute sessions (Diffey 2015). Even one visit to a tanning salon increased the risk of developing melanoma and other skin cancers.
Unless the FDA increases the requirement for UVA protection in sunscreens, poor-quality products will remain on the market and Americans will not have an easy way to gauge whether a product protects them adequately from UVA radiation.
Four European sunscreen ingredients merit close consideration for inclusion in U.S. products. Tinosorb S and Tinosorb M UVA filters, developed by BASF, appear to be much stronger and more photostable than avobenzone. In an effort to gain access to the U.S. market, BASF gave the FDA the results of toxicity and safety testing, including skin and eye irritation, phototoxicity, dermal toxicity and oral feeding studies (Regulations.gov 2008a, 2008b). The European Commission examined Tinosorb S in 1999 (SCCNFP 1999) and Tinosorb M last year (SCCS 2013), and determined that both sunscreens could safely be used in sunscreens in concentrations of up to 10 percent. In 2014, the FDA asked BASF for more details about tests of both chemicals.
La Roche-Posay, the active cosmetics division of the French cosmetics giant L’Oreal, developed Mexoryl SX, also called Ecamsule, which claims to offer strong, photostable protection. The company has sold sunscreens containing this chemical in Europe since 1993. In 2006, the FDA allowed La Roche-Posay to produce one specific sunscreen formulation with Mexoryl SX for the U.S. market. Canada admitted Mexoryl SX to its market and recently approved a successor chemical, Mexoryl XL, at concentrations of up to 10 percent (Canada 2013). In 2015, the FDA asked La Roche-Posay for more information about its chemicals’ safety tests before approving the company’s application to use them in a range of sunscreen products.
EWG agrees that all sunscreen chemicals now under consideration for the U.S. market should be subjected to careful review and high standards for safety, to protect Americans from chemicals that may endanger human health and ensure sunscreens provide UV protection. At present, scientists know considerably more about the effectiveness of these chemicals in shielding the skin than about their toxicity. Ingredients that offer ineffective skin protection or cause irritation, skin allergies or other health risks should be barred or tightly restricted. However, many of the active ingredients currently used in U.S. products have poor safety profiles.
It’s already clear that some European chemicals should not be admitted to the U.S. market. For instance, Merck has applied to the FDA for permission to market a sunscreen ingredient called 4-MBC or Enzacamene, a UVB filter. Researchers have detected 4-MBC in European women’s breast milk and in wildlife (Krause 2012). These findings are troubling because laboratory tests suggest that 4-MBC disrupts the hormone system (Krause 2012). Hormone disruptors pose particular dangers to fetuses because small perturbations to hormone systems could cause lasting changes in developing brains, thyroids and reproductive systems.
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