ORLANDO, Fla. — The U.S. Food and Drug Administration has approved a new sunscreen active ingredient for the first time in more than 20 years.
The FDA said it added bemotrizinol to the list of permitted over-the-counter sunscreen active ingredients.
Bemotrizinol is the first new active ingredient added to the OTC sunscreen monograph since the late 1990s, according to the agency.
FDA officials said the ingredient provides protection against both UVA and UVB rays and has low levels of absorption through the skin into the body.
The agency said it considers bemotrizinol generally recognized as safe and effective for use in sunscreens by adults and children 6 months and older.
The ingredient has already been marketed as a sunscreen ingredient in Europe and several other countries for years, according to the FDA.
The FDA said DSM Nutritional Products LLC submitted a request to add bemotrizinol, at concentrations up to 6%, as an active ingredient in OTC sunscreens.
The agency issued a proposed order in December 2025 and reviewed public comments before issuing its final order.
FDA officials said the change is meant to expand sunscreen options and support innovation in the sunscreen market.
Sunscreen products can enter the market without an approved drug application if they meet requirements under the FDA’s OTC monograph, including permitted active ingredients, uses and doses.
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