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FDA clears bemotrizinol, ending sunscreen filter drought

FDA clears – The U.S. Food and Drug Administration has finalized approval for bemotrizinol—also known as BEMT—adding it to the list of permitted active sunscreen ingredients for the first time in more than 25 years. The decision could bring more effective UVA protection to

The bottle might look the same on a drugstore shelf, but for sunscreen companies and advocates, the change is enormous: by finalizing approval for bemotrizinol—also known as BEMT—the FDA has finally opened the door to an ingredient used across Europe for decades.

Bemotrizinol is now officially added to the list of permitted active sunscreen ingredients in the United States. The FDA’s decision is the first update to its approved filters in more than 25 years, since 1999.

For the Environmental Working Group. the approval is a direct hit to a long-running problem: the UVA protection gap in U.S. sunscreens. “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.”.

Bemotrizinol matters because it is designed to absorb UV rays. The filter has been used in Europe and Asia since 1999, and it has often appeared under brand names including Parsol Shield and Tinosorb. It’s also classified as a chemical sunscreen ingredient—one of two broad categories of sunscreen.

Chemical sunscreens use ingredients that absorb ultraviolet rays while preventing them from reaching skin. and they tend to be transparent with better water resistance. Mineral sunscreens. by contrast. are typically thicker and can leave a white cast; they rely on ingredients like zinc oxide and titanium dioxide that reflect ultraviolet light.

The U.S. is already using other chemical filters such as oxybenzone and avobenzone. But EWG says the U.S. has relied too heavily on limited options. “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.’”.

In that framing, bemotrizinol is an upgrade. EWG says BEMT does not leave a white cast as a chemical sunscreen. The group also argues that it doesn’t break down in the sun—unlike avobenzone. Avobenzone has also been linked to allergic reactions.

EWG further says data show bemotrizinol is “minimally absorbed through the skin,” while oxybenzone has been detected in blood at 515 times the FDA’s threshold of concern “after a single weekend of application.” The group also says BEMT offers stronger UVA protection.

The FDA approval isn’t just a regulatory win—it immediately becomes a commercial moment. Sunscreens formulated with Parsol Shield, or BEMT, kick off 18 months of exclusive marketing rights in the United States. The bemotrizinol formulation used in that window is made by European skincare company DSM-Fermenich.

The approval also lands in the middle of a broader debate about why Americans have waited so long for new filters. Sunscreen regulation differs across the world. The European Union treats sunscreen as a cosmetic, while the U.S. classifies sunscreens as over-the-counter drugs. That means sunscreen filters need safety and efficacy data more in line with pharmaceutical ingredients.

EWG has been advocating for bemotrizinol since 2019. The push has also gained political attention. In 2023. Representative Alexandria Ocasio-Cortez began speaking out about the fact that more advanced sunscreen options were available overseas. and that the FDA hasn’t approved new ingredients in decades.

Ocasio-Cortez has also discussed using specific products abroad. In 2023, she told the New York Times that she uses Bioré and Beauty of Joseon—“two Asian brands that employ active ingredients not approved for use in the United States.”

The road to this approval has stretched across regulatory eras. The review process for BEMT took more than two decades. The original FDA application for the ingredient was filed in 2005, under a regulatory process that no longer exists.

In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was passed. The law reformed OTC drug regulation. making the process more efficient. while still requiring studies around absorption toxicology and safety reviews. DSM-Fermenich submitted a BEMT application under this newer process in 2024.

Even with the FDA’s decision, the next question is what comes after. Charlotte Palermino. founder of skincare company Dieux. told Fast Company that the brand is working on a sunscreen using BEMT. but that it will still take time to get the testing right. In an article for Elle published in April, Palermino said sunscreens formulated with BEMT could come as early as summer 2026.

Palermino has been blunt about the imbalance. While calling it “fantastic” that bemotrizinol has been approved, she said in the same spirit that “the United States has a lot of catching up to do.”

Dieux has also put the situation into a tool. The company created a webpage called Sun-Screener that lets people enter their sunscreen’s ingredients and receive an analysis. It flags international sunscreen filters not yet available in the U.S. including 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).”.

Palermino told Fast Company via email that. “Last I counted there were around 14 filters that are not approved in the US. but are in use internationally.” She added: “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 also said, “Furthermore, these newer filters allow for more elegant and less irritating formulas while having fantastic safety profiles.”

The bemotrizinol approval closes a long chapter of stagnation—more than 25 years—yet it also underlines how much ground remains to cover. Palermino said, “But if we truly want to catch up to the rest of the world . . . we will need more approvals in this market.” She added: “It’s a glimmer of hope in an otherwise grim landscape.”.

The sequence is hard to ignore: the FDA’s approved-filter list hasn’t moved since 1999, the regulatory pathway only updated after CARES Act reforms, and bemotrizinol’s approval now sets a timeline for what consumers may actually see on shelves—while other filters still sit outside the U.S. market.

FDA bemotrizinol BEMT sunscreen UVA protection gap Parsol Shield DSM-Fermenich EWG over-the-counter drug regulation CARES Act skincare regulation

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