Americans have fewer choices than Europeans in their sunscreen options and, on average, U.S. products, especially non-mineral sunscreens, 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. Most U.S. sunscreens prevent sunburn effectively when used correctly but they generally aren’t as good as European sunscreens for preventing the more subtle skin damage from UVA radiation.
EWG estimates that most sunscreens sold in the U.S. would be too weak to qualify for the European Union 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.
Zinc-oxide mineral based sunscreens that make up much of our recommended list performed were the best performing category of products in our testing. FDA tests of U.S. sunscreens found UVA protection varied significantly, even among those with the same SPF on their label – the measure of a product’s ability to shield against UVB rays that are responsible for sunburn. The disparity between U.S. and European sunscreens could be resolved if American manufacturers had access to the same UVA filters as European manufacturers.
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 used in U.S. and European products have not produced sufficient safety testing requested by the Food and Drug Administration. That’s why the FDA hasn’t approved a new sunscreen filter since 1996, despite manufacturers seeking to use eight sun-filtering chemicals allowed for use in the EU.
Although the FDA’s methods aim to protect public health, the delay leaves consumers 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 the FDA – which proposed these regulatory updates again in 2021 – has not yet finalized the changes, so they haven’t taken 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.
In countries subject to European Commission regulations, manufacturers voluntarily comply with a recommendation that all sunscreens offer UVA protection at least one-third as potent as the SPF. For example, if 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.
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 eight 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.
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 are considered safe and effective: Zinc oxide and titanium dioxide. The FDA has approved 12 other non-mineral active ingredients and some can be found in 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 the FDA’s permission to use eight sun-filtering chemicals developed by European companies.
Four of these chemicals – Tinosorb S, Tinosorb M, Mexoryl SX and Mexoryl XL – appear to be more effective than avobenzone, one of the most common UVA filters permitted by the FDA. These four chemicals deserve to be considered for making U.S. sunscreens.
Tinosorb S – the trade name for Bemotrizinol and the ingredient also marketed as Parsol Shield – 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 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 the FDA’s data requests – and in the meantime, Americans are being shortchanged with inadequate sunscreens, especially compared to European ones.
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 for more comprehensive safety testing data before it would allow widespread usage.
While the FDA has been slow to act, American consumers have started seeking out international sunscreen products in the U.S.
Under the Federal Food, Drug, and Cosmetic Act, it is illegal to sell sunscreens that are not FDA-approved, including products with ingredients like Tinosorb S, Tinosorb M, Mexoryl SX and Mexoryl XL. It is also illegal for consumers to purchase non-FDA approved sunscreens.
But on a case-by-case basis, the FDA may permit the importation of over-the-counter products like sunscreen and certain drugs for personal use under its informal policy addressing personal importations. So, if you try to bring sunscreen home from your European vacation, be aware that it could get confiscated at customs.
Consumers might also find these products through third-party retailers on online stores like Amazon but they should be cautious of counterfeit products and illegitimate companies.
In 2019, our public comment letter to the FDA suggested the agency consider allowing the four promising sunscreen ingredients in the U.S. market while tests are still being conducted. The current data suggest these 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 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.
