In a positive decision for public health and consumer protection, the Food and Drug Administration Tuesday finalized its approval of the first new ultraviolet filter in more than 25 years, which has been determined to be a safe and effective active ingredient to use in U.S. sunscreens.
The chemical, bemotrizinol, or 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, an advocacy organization, that has urged the agency to allow bemotrizinol to be added to sunscreens since 2019, said the decision is a 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,” David Andrews, Ph.D., chief science officer at the EWG, said in a statement. “For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward.”
Andrews said the FDA’s go-ahead will finally bring more effective, safer sun protection to American store shelves.
What sunscreens deliver
Traditional U.S. sunscreens excel at blocking the radiation that causes visible sunburns, ultraviolet B rays. But they 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 United States, claiming more than one life every hour, with estimates of more than 200,000 cases of both types of melanoma predicted in 2026, according to the Melanoma Research Foundation.
EWG’s research found U.S. sunscreens deliver on average just 24 percent of the UVA protection implied by their sun protection factor, or SPF, labels. Most Americans buying high-SPF products get just a fraction of the protection they believe they’re buying.
The FDA’s approval of bemotrizinol is the most significant step in a generation toward fixing that problem, Andrews said.
What’s bemotrizinol and why is it better?
Bemotrizinol has been used safely in sunscreens in Europe and Asia since 1999 under brand names including Tinosorb S by BASF and Parsol Shield by DSM. The ingredient has a 27-year safety track record abroad, though some of those jurisdictions have weaker data requirements than the U.S.
Data submitted to the FDA confirms that at concentrations up to 6 percent, bemotrizinol is minimally absorbed through the skin, with average absorption levels below the concentration the FDA considers indicative of systemic exposure.
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.
Bemotrizinol solves problems current U.S. sunscreen ingredients can’t.
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 leaves a white cast after it’s been applied.
What comes next
Parsol Shield will have 18 months’ exclusive marketing rights in the U.S. of bemotrizinol.
After that period, other manufacturers may use it in their formulations
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.
The EWG will update its Guide to Sunscreens as products with bemotrizinol reach the market.
In the meantime, the 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 in the U.S.
Good news, but a broken system remains
The approval of bemotrizinol is positive for consumers, but it shines a harsh spotlight on a federal system stuck in neutral,” said Melanie Benesh, EWG’s vice president for government affairs.
In 2019 and 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.
Benesh said sunscreen manufacturers have been unwilling to produce the safety data the FDA needs to approve additional new filters, adding Congress needs to step in.
“Meanwhile, sunscreen manufacturers are refusing to provide the FDA with safety data for other UV filters, prioritizing corporate secrecy over public health,” she said. “American consumers are then left with fewer options than people in Europe and Asia have had for decades.”
How to navigate store shelves
While bemotrizinol products make their way to store shelves, the best sunscreen is the one that actually gets used. The EWG offers these suggestions 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.
For non-mineral sunscreens, look for products with 3 percent avobenzone and check the EWG’s Guide to Sunscreens.
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 percent of UVB rays. SPF 100 blocks just 1 percent more. The 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.
