For the first time in over 25 years, the Food and Drug Administration is proposing to approve a new sunscreen ultraviolet, or UV, filter for the U.S. market: bemotrizinol, or BEMT.
It’s a UV filter that since 1999 has been used in sunscreens in other countries, offering greater protection against harmful ultraviolet A, or UVA, rays.
UVA radiation is the sun wavelength that penetrates deepest into the skin, leads to premature skin aging, suppresses the immune system and increases risk of skin cancers, like melanoma. The sunscreens most Americans use do not provide enough UVA protection.
For decades, Americans have had access to fewer sunscreen ingredients than consumers in Europe and Asia. In some cases the sunscreen sold in the U.S. offers UVA protection that is much worse than the sunscreens sold overseas.
EWG’s own peer-reviewed research found that U.S. sunscreens deliver on average just 24% of the UVA protection implied by their SPF labels.
But that might be about to change.
Proposal could improve sunscreen options
In late 2025, the FDA proposed to add BEMT to the U.S. list of active ingredients allowed in sunscreens. The proposal allows for use up to 6%.
If the agency finalizes its decision, BEMT will be the first new UV filter approved for the U.S. market in over 25 years.
BEMT could be widely adopted into sunscreen formulations, since it will be allowed for use in combination with almost all currently approved active ingredients.
The only restriction on using the filter would be a ban on combining it with two other UV filters: para-aminobenzoic acid, or PABA, and trolamine salicylate. In 2019 and again in 2021, the FDA proposed these two filters are not “generally recognized as safe and effective,” or GRASE, for use in sunscreens sold in the U.S.
In the European Union, BEMT is sold by numerous companies under trade names that include Tinosorb® S, Parsol® Shield, AakoSun BEMT, and Escalol™ S. The chemical company CIBA Speciality Chemicals invented the filter and applied for FDA approval in 2005, so it has already had more than two decades of regulatory review. CIBA was acquired by BASF, which manufactures and markets BEMT internationally.
DSM, a pharmaceutical company, has been leading calls for FDA approval of its version of BEMT, sold as PARSOL® Shield. If the FDA finalizes its approval, DSM would have 18 months of marketing exclusivity.
After that period, other manufacturers would be able to use BEMT in their formulations, which should expand the range of products available to consumers.
Data submitted to the FDA about products with BEMT at concentrations up to 6%, led the agency to propose the ingredient as safe and effective.
Similarly, European Union Scientific Committee on Consumer Safety 1999 findings report that at levels up to 10%, BEMT does not irritate the skin and is not associated in animal studies with harm to the reproductive system.
A step forward in UVA protection
The most important use of BEMT would be closing the UVA protection gap that has plagued American sunscreens for decades.
In the U.S., sunscreens are regulated as over-the-counter drugs, and the FDA oversees sunscreen safety. The agency said in 2019 and 2021 only two of 16 ingredients on the market – zinc oxide and titanium – are GRASE.
Due to safety concerns, the FDA has flagged PABA and trolamine salicylate as not GRASE.
The 12 other ingredients on the U.S. market are also not GRASE. But that status is primarily due to insufficient data. The agency has requested additional safety data on these ingredients, although they are still allowed for use in products sold in the U.S.
Problems with existing filters
The best sunscreens are those that provide broad spectrum protection – from both UVA and ultraviolet B, or UVB, rays.
UVA rays don’t easily burn the skin. But they can cause it to age, suppress the immune system and contribute to the development of skin cancer.
Zinc oxide and avobenzone are the only two UV filters in U.S. sunscreens today that are effective at reducing UVA rays significantly.
Avobenzone is chemically unstable and must be paired with other ingredients to prevent it from breaking down in sunlight. Breakdown products of avobenzone have also been shown to cause allergic reactions.
BEMT solves these problems. According to the FDA review, it provides strong broad-spectrum protection against both UVA and UVB radiation.
It is more stable in sunlight than avobenzone and – unlike avobenzone – can be combined with zinc oxide to provide greater UVA protection. It also has more safety data than any non-mineral filters on the U.S. market.
Minimal health concerns
Data suggests that most available non-mineral UV filters may have safety concerns.
The FDA’s proposed approval of BEMT includes extensive scientific review requiring data on absorption into the body and likelihood of irritation and sensitization, as well as animal studies of carcinogenicity and potential to harm reproduction or development.
Minimal skin absorption
Documents submitted to the FDA report that BEMT at concentrations up to 6% is minimally absorbed into the body and the amount that does absorb is below the concentration FDA considers to be indicative of systemic exposure after application.
Compared to the other 12 ingredient chemical filters on the U.S. market, BEMT has robust data for safety and does not absorb into the skin.
FDA studies in 2019 and 2020 showed that a one-time application of six other chemical actives – oxybenzone, homosalate, octisalate, octocrylene, avobenzone and octinoxate – were absorbed through the skin at levels above 0.5 nanograms per milliliter, the maximum concentration the FDA says may be found in blood without potential safety concerns.
One ingredient, oxybenzone, was detected at 258.1 nanograms per milliliter in blood after multiple lotion applications – 515 times the FDA’s threshold of concern.
No evidence of carcinogenicity
In a two-year long animal study, BEMT was applied to the skin of rats. The results indicated that BEMT did not cause abnormal, unregulated growth on the skin. This suggests that BEMT is likely not cancer-causing when applied to skin.
No reproductive harm
The FDA also reviewed a multi-generational reproductive study and concluded that there were no harmful reproductive effects on the rats giving birth or the survival and development of their offspring.
Not irritating
Data submitted to the FDA also included a repeated insult patch test and cumulative irritation patch test, a photo-allergenicity test and a phototoxicity test. Results suggest BEMT was not irritating to the skin.
More options are still needed
Approving BEMT is a meaningful step forward, but it doesn’t solve every problem with the U.S. sunscreen market.
For over 20 years, companies have submitted some safety data to the FDA in hopes of adding BEMT to the U.S. market. Even with the addition of avobenzone in 1999, the U.S. has been left with fewer options because the FDA’s approval process has been so slow.
In sunscreens sold in Europe and elsewhere worldwide, BEMT is formulated with other active ingredients that are not approved for use in the U.S.
Sunscreens are often formulated with a mixture of active ingredients and, even with the addition of BEMT, the U.S. sunscreen market, would still lag behind the EU market.
In the U.S., 16 active ingredients are permitted and in the EU, about 30 filters are available for formulation.
With a law known as the 2020 CARES Act, the FDA’s rules for over-the-counter drugs were modernized. The law restructured the regulation of all OTC monograph drugs and replaced the legacy rulemaking process with a streamlined administrative order system. This change simplified the regulatory process.
If the FDA finalizes the addition of BEMT, it’ll be the first new sunscreen active ingredient allowed in the U.S. in nearly 30 years. Other sunscreen companies could also submit applications to allow additional sunscreen ingredients on the market.
But, so far, these manufacturers seem unwilling to produce the safety data that the FDA requests.
Tips for sun safety
- Cover up and wear sunglasses. Shirts, hats, shorts and pants provide the best protection from UV rays. Good shades protect your eyes from UV radiation, which may cause cataracts.
- Find shade or make it. Picnic under a tree, read beneath an umbrella or take a canopy to the beach. Keep infants in the shade, because they are still developing the tanning pigments, known as melanin, that protect skin.
- Wear sunscreen. EWG’s Guide to Sunscreens evaluates the safety and efficacy of SPF-rated products, including sunscreens for recreational use and SPF-rated daily-use moisturizers and lip products. The best ratings are for products that provide broad spectrum protection formulated with ingredients that pose fewer health concerns when absorbed by the body.
- Look for EWG Verified®. Consumers can also shop for EWG Verified sunscreens, making it easier to find products that are safer and effective.
