WASHINGTON – In a landmark decision for public health and consumer protection, the Food and Drug Administration today finalized its approval of the first new ultraviolet filter in more than 25 years deemed a safe and effective active ingredient in U.S. sunscreens.
The chemical, bemotrizinol, also known as BEMT, will give American consumers access to a level of ultraviolet A protection that has until now been unavailable on U.S. store shelves. The regulatory review process leading up to this approval took more than two decades.
Bemotrizinol offers a stable non-mineral option that doesn’t break down in the sun, unlike one of two previously approved UVA filters, avobenzone.
Sunscreen products formulated with non-mineral active ingredients are often the consumer’s preference. That’s because mineral-based sunscreens often leave a white cast on the skin, a quality that doesn’t work for many people, especially people of color.
The Environmental Working Group, which since 2019 has urged the agency to allow bemotrizinol to be added to sunscreens, hailed the decision a monumental victory for health and wellness.
Closing the UVA gap
“This is a great day for American consumers and everyone who has fought to improve sunscreen options and close the UVA protection gap in U.S. sunscreens,” said David Andrews, Ph.D., chief science officer at EWG.
“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward. The approval of bemotrizinol will help change that. The FDA’s go-ahead will finally bring more effective, safer sun protection to American store shelves.
“This is a win that has been a long time coming,” said Andrews.
What sunscreens deliver
Traditional U.S. sunscreens excel at blocking the radiation that causes visible sunburns, ultraviolet B rays. But they routinely fail to shield against deep-penetrating UVA rays, which drive premature aging, suppress the immune system and are the primary contributor to skin cancer, according to the American Cancer Society.
Skin cancer is the mostly commonly diagnosed cancer in the U.S., claiming more than one life every hour, with estimates of over 200,000 cases of both types of melanoma predicted in 2026, according to the Melanoma Research Foundation.
EWG’s peer-reviewed research found U.S. sunscreens deliver on average just 24% of the UVA protection implied by their sun protection factor, or SPF, labels. Most Americans reaching for high-SPF products get just a fraction of the protection they believe they’re buying.
Today’s approval is the most significant step in a generation toward fixing that problem.
“For too long, American consumers have been applying sunscreen and believing they were fully protected, not knowing that their product was delivering far less UVA protection than the label implied,” said Alexa Friedman, Ph.D., senior scientist at EWG.
“Bemotrizinol changes the calculus of sun care. It is highly photostable, meaning it won’t break down when hot summer sun hits your skin – unlike avobenzone, currently the only non-mineral filter in the U.S. that provides meaningful UVA coverage,” she said.
“And it provides strong, stable broad-spectrum protection against both UVA and UVB radiation. Better yet, unlike the older non-mineral filters, it can be combined with zinc oxide to provide strong broad spectrum protection with less white cast.
“American consumers deserve access to the best available sun protection. Today they’re finally getting closer to it,” added Friedman.
What is bemotrizinol and why is it better?
Bemotrizinol has been used safely in sunscreens across Europe and Asia since 1999 under brand names including Tinosorb® S by BASF and Parsol® Shield by DSM. The ingredient has amassed a 27-year safety track record abroad, though some of those jurisdictions have weaker data requirements than the U.S.
The original application for FDA approval was filed in 2005 under a regulatory process that has since been discontinued. One company, DSM, submitted its most recent request to the FDA in 2024, under an updated regulatory process established by the CARES Act. It has taken more than two decades of regulatory review to reach today’s approval.
Data submitted to the FDA confirms that at concentrations up to 6%, bemotrizinol is minimally absorbed through the skin, with average absorption levels below the concentration the FDA considers indicative of systemic exposure. Compare that to oxybenzone, which was detected in blood at 515 times the FDA’s threshold of concern after a single weekend of application. Bemotrizinol does not meaningfully enter the bloodstream.
The FDA’s review also included a two-year animal study that found no evidence of cancer-causing effects when bemotrizinol is applied to skin. A multigenerational reproductive study found no harmful effects on reproductive outcomes or offspring development.
Skin irritation tests found bemotrizinol was not irritating at permitted concentrations.
The European Union’s Scientific Committee on Consumer Safety reached the same conclusions as far back as 1999.
Crucially, bemotrizinol solves problems current U.S. sunscreen ingredients cannot.
Zinc oxide and avobenzone are the only two UV filters in U.S. sunscreens that provide meaningful UVA protection. But avobenzone is chemically unstable – it breaks down in sunlight, reducing its effectiveness precisely when it is needed most. Avobenzone’s breakdown products have been linked to allergic reactions.
Zinc oxide, for all its ability to provide the most stable, balanced broad-spectrum UVA and UVB protection, leaves a white cast after it’s been applied.
Until today, the FDA had proposed that only sunscreens containing zinc oxide and titanium dioxide – both mineral ingredients – would be generally recognized as safe and effective.
What comes next
Today’s approval of bemotrizinol triggers 18 months’ exclusive marketing rights in the U.S. of Parsol Shield, a proprietary bemotrizinol formulation.
After that period, other manufacturers may use it in their formulations, driving broader availability and more competitive pricing.
Consumers shopping for sunscreen with bemotrizinol should look for “bemotrizinol” or “BEMT” in the active ingredients list or the trade name Parsol Shield on product packaging. It may also be listed by its internationally standardized name, bis-ethylhexyloxyphenol methoxyphenyl triazine.
EWG will update its Guide to Sunscreens as products with bemotrizinol reach the market.
In the meantime, EWG’s top recommendation for daily use remains mineral sunscreens formulated with zinc oxide, which provide the most stable and balanced broad-spectrum UVA and UVB protection currently available on U.S. shelves.
Good news – but a broken system remains
Today’s approval is cause for genuine celebration. It is also a reminder of how far the U.S. regulatory system still has to go.
Even with bemotrizinol added to the mix, U.S. sunscreen formulators will have access to 16 approved UV filters. European formulators have access to approximately 30.
In 2019 and again in 2021, the FDA proposed meaningful reforms to sunscreen regulation that included stronger UVA standards, SPF value limits, better labeling and updated safety data requirements. None of those reforms has been finalized.
Other sunscreen manufacturers have so far been unwilling to produce the safety data the FDA needs to approve additional new filters.
“This approval is a triumph of consumer advocacy, but it also shines a harsh spotlight on a federal system stuck in neutral,” said Melanie Benesh, EWG’s vice president for government affairs.
“Meanwhile, sunscreen manufacturers are refusing to provide the FDA with safety data for other UV filters, prioritizing corporate secrecy over public health. American consumers are then left with fewer options than people in Europe and Asia have had for decades.
“Congress must step in. We need binding deadlines for chemical testing and real enforcement to pull non-compliant, unsafe products from the market entirely. American families have waited long enough.
“Companies must also do more. Manufacturers of additional sunscreen filters available internationally should request market access from the FDA and provide the FDA with the necessary data so consumers have more options,” Benesh added.
How to navigate store shelves
While bemotrizinol products make their way to store shelves, the best sunscreen is the one that actually gets used. Here’s how to choose strong sun protection today:
Prioritize zinc oxide. Mineral sunscreens with zinc oxide provide the most stable, balanced broad-spectrum UVA and UVB protection available and are EWG’s top recommendation for daily use.
For non-mineral sunscreens, look for products formulated with 3% avobenzone and check EWG’s Guide to Sunscreens for options that meet EWG’s safety and efficacy standards.
Avoid oxybenzone and octinoxate, which are linked to hormone disruption, and skip products with undisclosed “fragrance.”
Be wary of high SPF numbers. SPF 50 blocks 98% of UVB rays. SPF 100 blocks just 1% more. The negligible difference can create a false sense of security, since high-SPF products often provide no better UVA protection than lower-SPF alternatives.
Use EWG’s tools. Shoppers can search the 2026 Guide to Sunscreens, use the EWG Healthy Living app to scan products while they shop, and look for the EWG Verified® mark, which requires sunscreens to exceed both U.S. and European UVA protection standards.
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The Environmental Working Group is a nonprofit, non-partisan organization that empowers people to live healthier lives in a healthier environment. Through research, advocacy and unique education tools, EWG drives consumer choice and civic action. Visit www.ewg.org for more information.
