Americans have fewer choices than Europeans in their sunscreen options, on average, American products have notably poorer protection from harmful ultraviolet A, or UVA, rays.
UVA rays have less energy than ultraviolet B, or UVB, rays and don’t burn the skin,but can cause the skin to age, suppress the immune system and contribute to the development of skin cancer. Whereas 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 UVA radiation.
EWG estimates that most sunscreens sold in the U.S. would be too weak for the European market because they don’t filter UVA rays well enough. An EWG study of laboratory tests of 51 sunscreen products found that only 35 percent of the products tested met the EU standard, but 94 percent would pass the current U.S. standard. And FDA tests of U.S. products found that UVA protection varied significantly, even among those carrying the same SPF on their label . This disparity between U.S. and European sunscreens could be resolved if American manufacturers had access to the same UVA filters European manufacturers use.
Why Europe has better sunscreens
In the U.S., sunscreens are regulated as non-prescription drugs, which means new UV filter ingredients are subject to the same lengthy review process that all pharmaceutical drugs must undergo. Companies that manufacture sunscreen ingredients –ingredients currently on the market and those in Europe– have not produced the safety testing that the Food and Drug Administration has requested. ConsequentlySo no new sunscreen filters have been approved by the Food and Drug Administration since 1996, despite sunscreen makers having applied to use 8 sun-filtering chemicals developed by European companies.
Although the FDA’s methods are intended to protect public health, consumers are left with subpar sunscreens in the meantime. In 2019, the FDA proposed rules to strengthen the UVA protection offered by U.S. sunscreens, expressing concern over the role UVA rays play in cancer development. But these new rules, proposed again in 2021, have yet to be finalized or go into effect.
The EU regulates sunscreens as cosmetics, which allows more flexibility in which active ingredients sunscreen manufacturers can use to protect against UVA rays. The EU has 34 UV filters approved for use in sunscreens, compared to 16 in the U.S. Further, in countries regulated by the European Commission, manufacturers voluntarily comply with a recommendation that all sunscreens offer UVA protection at least one-third as potent as the SPF, the measure of a product’s ability to shield against UVB rays, which are the rays responsible for sunburn. So if, for instance, a product advertises SPF 30, its UVA protection must be at least 10.
British researcher Brian Diffey 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 the skin than the European products did . A 2017 study on UVA protection standards in the United States and Europe reported that while 19 of the 20 sunscreens tested met the U.S. requirements, only 11 met the European requirements. The authors attributed this finding to the less stringent U.S. standards and the limited number of UVA filters approved for use in U.S. formulations.
Only two FDA-approved ingredients offer strong protection against UVA rays: zinc oxide and avobenzone. Sunscreen manufacturers of products for the European market 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.
There is a disconnect between the chemical approval process and what’s available on the market. The FDA is reluctant to approve new sunscreen ingredients, but there’s little reassurance about most of the chemicals already being used in U.S. products.
According to the FDA’s 2021 proposed sunscreen order , only two active ingredients allowed in U.S. sunscreens, zinc oxide and titanium dioxide, are considered safe and effective. There are 12 other chemical-based active ingredients that have been approved by the FDA, and some can be found in most products on the U.S. market. But the agency doesn’t have enough data to determine their safety.
EWG believes all sunscreen chemicals should be subject to careful review and high standards of safety. This is critical to ensuring sunscreens provide adequate UV protection and protect Americans from chemicals that may endanger human health. Ingredients that offer ineffective skin protection or cause irritation, skin allergies or other health risks should be tightly restricted or barred.
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 and deserve to be considered for the U.S. market.
Tinosorb S and Tinosorb M UVA filters, developed by BASF, also seem to be more stable than avobenzone. The European Commission has studied both Tinosorb S and Tinosorb M and determined they may safely be used in sunscreens in concentrations of up to 10 percent .
The FDA has responded that the sunscreen manufacturers had not submitted enough information to prove these chemicals were safe and effective for use. The agency asked for more data, including complete study results, measurements of ingredient levels in people’s blood, and long-term studies of systemic toxicity and potential endocrine system disruption.
The companies have yet to satisfy FDA requests – and in the meantime, Americans are being shortchanged.
Mexoryl SX, also called ecamsule, was developed by the cosmetics manufacturer La Roche-Posay, which claims it offers strong protection. The company has sold sunscreens containing this chemical in Europe since 1993. Canada admitted it to its market in 2013 and approved a successor chemical, Mexoryl XL, at concentrations up to 10 percent.
In 2006, the FDA allowed La Roche-Posay to produce one specific sunscreen formulation with Mexoryl SX for the U.S. market. But in 2015, as it had with other companies, the FDA asked La Roche-Posay for more information about its other chemicals’ safety tests before allowing the company to use them in a range of sunscreen products.
Our public comment letter to the FDA in 2019 suggested the agency consider allowing these four ingredients on the market while tests are still being conducted. The current data suggest these four ingredients are as safe – if not more so – as those chemicals, like oxybenzone, that have been on the market for many years. These ingredients would give manufacturers – and therefore, consumers – more options for products with good broad-spectrum protection. For too long U.S. consumers have been stuck with inadequate products on store shelves.
