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Americans have fewer choices and notably poorer protection than Europeans do from ultraviolet A rays in their sunscreen options. Although most U.S. sunscreens prevent sunburn effectively when used correctly, they aren’t as good as European sunscreens at preventing the more subtle skin damage 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, suppress the immune system and contribute to the development of melanoma.
In 2019, the Food and Drug Administration’s proposed sunscreen rules expressed concern about the role of UVA rays in the development of skin cancer. The proposed rule stated that “UVA exposure is a significant concern,” and that high SPF products currently on the market may expose users to “excessively large UVA doses” (FDA 2019). The FDA has proposed to strengthen the UVA protection offered by U.S. sunscreens, but without new active ingredients designed to reduce UVA rays, the changes to sunscreen formulations will be minor.
There are many ingredients that reduce UVA radiation, but chemical manufacturers have not provided the FDA with test data that satisfy its concerns about ingredient safety. The regulations governing how over-the-counter drugs are regulated were overhauled within one of the recently passed coronavirus stimulus bills. This change may enable faster review of new ingredients.
Sunscreen manufacturers that make products for the European market 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 FDA permits in products sold on the American market. Only two 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 it doesn’t relax the standards companies must meet to prove new ingredients are both safe and effective.
In 2015, the FDA responded that the companies involved had not submitted enough information to prove their chemicals were, in fact, safe and effective for use (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. The FDA has also proposed that all sunscreen ingredients, including those already in use, need to have adequate safety testing data.
Some information the FDA wants, such as complete copies of studies, might be easy for sunscreen makers to produce. But in other cases, the companies could take years to satisfy FDA requests. In the meantime, Americans are being shortchanged.
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 – which included the modern UVA filters – allowed, on average, three times more UVA rays to pass through to skin than European products did (Diffey 2015). The FDA proposed changes to the UVA protection standard that should remove the poorest-performing products from U.S. shelves, but will likely fail nonetheless to offer the same level of protection as European products do.
In the nations regulated by the European Commission, manufacturers voluntarily comply with a recommendation that all sunscreens must offer UVA protection 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 (European Commission 2006, Colipa 2009). In other words, if a product advertises SPF 30, its UVA protection must be at least 10.
The sunscreen formulations on the U.S. market today are relatively unchanged from past years. EWG estimates that, because of inadequate UVA filtering, about two-thirds of the beach and sport sunscreens we assessed this year are too weak for the European market. Laboratory tests of 20 common U.S. sunscreens confirmed these findings: 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 at a tropical latitude, tourists with fair skin could successfully prevent sunburns with a poor-quality sunscreen, but at the same time receive as much UVA exposure as they would during 10 eight-minute sessions at a tanning salon (Diffey 2015). Even one visit to a tanning salon increased the risk of developing melanoma and other skin cancers.
In February 2019, the FDA released a final draft of the sunscreen monograph, in which the agency proposed to strengthen its standard for UVA protection. It also proposed a more protective UVA standard in 2007, but never implemented it, because of significant industry pressure. The proposed change would be a win for consumers, because unless the FDA increases the requirement for UVA protection in sunscreens, poor-quality products will remain on the market.
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 less affected by exposure to light than avobenzone. In an effort to gain access to the U.S. market, BASF gave the FDA the results of toxicity and safety tests, including skin and eye irritation, phototoxicity, dermal toxicity and oral feeding studies (Regulations.gov 2008a, 2008b). The European Commission has examined Tinosorb S (SCCNFP 1999) and Tinosorb M (SCCS 2013) and determined that both ingredients 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.
Cosmetics manufacturer La Roche-Posay 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 also 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 it approved 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 subject to careful review and high standards of safety to protect Americans from chemicals that may endanger human health and ensure sunscreens provide UV protection.
Scientists now know much more about these chemicals’ effectiveness in shielding the skin than they do about their toxicity. Ingredients that offer ineffective skin protection or cause irritation, skin allergies or other health risks should be tightly restricted or barred. However, many of the active ingredients currently used in U.S. products have poor safety profiles.
According to the FDA’s 2019 proposed final sunscreen monograph, only two active ingredients allowed in U.S. sunscreens, zinc oxide and titanium dioxide, are considered safe and effective. The agency has insufficient data to determine the safety of 12 chemical-based active ingredients that have already been approved, some of which can be found in the vast majority of the products found on the U.S. market.
It’s clear that some European chemicals should not be allowed on 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 the developing fetus, because small disturbances to hormone systems can cause lasting changes in developing brains, thyroids and reproductive systems.
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