A sunscreen ingredient that has been used across Europe for decades can now officially come stateside.
The Food and Drug Administration (FDA) finalized its approval of bemotrizinol, also called BEMT, officially adding it to the list of permitted active sunscreen ingredients.
It marks the first time that the FDA’s list of approved filters has been updated in more than 25 years, since 1999.
The Environmental Working Group (EWG) called the change a “landmark decision for public health and consumer protection.”
“This is a great day for American consumers,” David Andrews, chief science officer at EWG, said in a statement, “and everyone who has fought to improve sunscreen options and close the UVA protection gap in U.S. sunscreens.”
What is Bemotrizinol?
Bemotrizinol is an ingredient added to sunscreens that absorbs UV rays. The filter has been used in Europe and Asia since 1999, often appearing under brand names like Parsol Shield and Tinosorb.
The FDA approval kicks off 18 months of exclusive marketing rights for Parsol Shield in the United States; that bemotrizinol formulation is made by European skincare company DSM-Fermenich.
Sunscreens come in two main types: mineral and chemical. Mineral sunscreens are often thicker and known for leaving a white cast on the skin. They use ingredients like zinc oxide and titanium dioxide to reflect ultraviolet light.
Chemical sunscreens instead use ingredients that absorb those UV rays while preventing them from actually reaching into your skin, and these sunscreens tend to be transparent and can have better water resistance.
Bemotrizinol is a chemical sunscreen filter; other chemical sunscreen ingredients include oxybenzone and avobenzone.
According to EWG, mineral ingredient zinc oxide and chemical filter avobenzone are the only two UV filters in U.S. sunscreens that provide “meaningful UVA protection.”
The FDA approval of BEMT is noteworthy because it addresses issues other filters have. As a chemical sunscreen, it doesn’t leave a white cast. The ingredient also doesn’t break down in the sun—unlike avobenzone. (Avobenzone has also been linked to allergic reactions).
Data shows BEMT is “minimally absorbed through the skin,” EWG adds; oxybenzone, by contrast, has been detected in blood at 515 times the FDA’s threshold of concern “after a single weekend of application.” And BEMT actually offers stronger UVA protection.
“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward,” Andrews said. “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.”
Why is the U.S. so behind on sunscreen technology?
Sunscreen is regulated differently in different places. The European Union treats sunscreen as a cosmetic; the U.S. classifies sunscreens as an over-the-counter drug. That means sunscreen filters need safety and efficacy data in line with pharmaceutical ingredients.
EWG has been advocating for the approval of bemotrizinol since 2019. And it’s not alone.
In 2023, Representative Alexandria Ocasio-Cortez began speaking out about the fact that more advanced sunscreen options were available overseas, and how the FDA hasn’t approved new ingredients in decades.
She herself uses Bioré and Beauty of Joseon, she told the New York Times in 2023, which noted that those are “two Asian brands that employ active ingredients not approved for use in the United States.”
The regulatory review process for BEMT has taken more than two decades; the original FDA application for the ingredient was filed in 2005. But that was under a regulatory process that no longer exists.
In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was passed, and that reformed OTC drug regulation. It became more efficient, but still required studies around absorption toxicology, and safety reviews. DSM-Fermenich submitted a BEMT application under this new process in 2024.
Still more sunscreen advancements to go
Sunscreens formulated with Parson Shield, or BEMT, are now in the works. Charlotte Palermino, founder of skincare company Dieux, told Fast Company that the brand is currently working on a sunscreen with BEMT, but that it will still take a while to get all the testing right.
In an article for Elle published in April, Palermino also explored the changes to U.S. sunscreen ingredients, and said sunscreens formulated with BEMT could come as early as summer 2026.
Palermino, who has also been outspoken about America’s “sunscreen problem” for years, said that while it’s “fantastic” that bemotrizinol has now been approved, “the United States has a lot of catching up to do.”
Dieux created a webpage called Sun-Screener, which allows people to enter their sunscreen’s ingredients and get an analysis. It flags international sunscreen filters that aren’t yet available in the U.S., like Uvinul A Plus, a chemical filter approved in the EU that Dieux says “provides strong UVA protection and is VERY photostable (meaning it is easier to formulate with).”
“Last I counted there were around 14 filters that are not approved in the US, but are in use internationally,” Palermino told Fast Company via email. “For context, there are I believe 16 filters approved for use in the US right now . . . that would almost double our palette to choose from.”
She added, “Furthermore, these newer filters allow for more elegant and less irritating formulas while having fantastic safety profiles.”
The approval of BEMT comes after 25-plus years of sunscreen stagnation. “But if we truly want to catch up to the rest of the world . . . we will need more approvals in this market,” Palermino says. “It’s a glimmer of hope in an otherwise grim landscape.”