The FDA added bemotrizinol to its list of permitted sunscreen active ingredients on Tuesday, marking the first time the agency has approved a new over-the-counter sunscreen compound since the late 1990s.
Bemotrizinol, long available in Europe, blocks both UVA and UVB rays and is cleared for adults and children 6 months and older
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The FDA added bemotrizinol to its list of permitted sunscreen active ingredients on Tuesday, marking the first time the agency has approved a new over-the-counter sunscreen compound since the late 1990s.
Bemotrizinol protects against both ultraviolet A and B rays, has low levels of absorption through the skin, and is cleared for use by adults and children 6 months and older, the FDA said. The ingredient has been available in Europe and many other countries for years, having received authorization from European authorities in 1999, according to STAT News.
The approval fills a notable gap in the U.S. market. Chemical sunscreen filters currently available in the United States protect against either UVA or UVB rays but not both — manufacturers typically blend multiple chemicals to achieve broad-spectrum protection. Mineral-based options such as zinc oxide block both ray types but leave a white cast on the skin. Bemotrizinol offers broad-spectrum coverage in a single chemical ingredient without that residue, according to NBC News.
The ingredient is also more stable than existing chemical filters, meaning it breaks down less when exposed to sunlight, according to CBS News.
DSM Nutritional Products, a Dutch company that brought the original request to the FDA, will market bemotrizinol under the Parsol Shield brand name when it first hits U.S. store shelves, according to The Associated Press. Rival manufacturers will gain access to the ingredient once an 18-month exclusivity window closes. Products are expected to be available by the end of the year.
Reaching this point required navigating a regulatory pathway that Congress created in 2020, and bemotrizinol is the first sunscreen ingredient to complete that updated process. DSM filed the ingredient with the FDA for review as far back as 2005, according to the AP. The FDA issued a proposed order in December 2025 and finalized it Tuesday, seven months later, the agency said.
"For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward," said David Andrews, chief science officer at the Environmental Working Group. "The approval of bemotrizinol will help change that."
Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement that the action would "increase competition and consumer confidence in sunscreen products."
Industry trade group the Personal Care Products Council welcomed the decision while pressing the FDA to go further on sunscreen regulation, according to CNN.
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