The agency has added bemotrizinol to the over-the-counter sunscreen monograph, making it the first new sunscreen active ingredient approved for use in the United States since the late 1990s.
The US Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients, marking the first new sunscreen ingredient added to the over-the-counter (OTC) sunscreen monograph in more than 20 years.
The agency finalized the action on June 9, allowing bemotrizinol to be used in OTC sunscreen products at concentrations of up to 6%. The ingredient, which has been used in Europe and other countries for years, provides protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays.
“As promised in the Trump Administration’s MAHA Strategy Report, HHS (Department of Health and Human Services) is advancing innovation by bringing a new sunscreen ingredient to the US market for the first time in 20 years,” says HHS Secretary Robert F. Kennedy Jr in a release. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”
According to a press release from the FDA, bemotrizinol has low levels of absorption through the skin into the body and is considered generally recognized as safe and effective for use in sunscreens by adults and children 6 months of age and older.
FDA finalized the order within seven months of issuing a proposed rule in December 2025. The agency said the ingredient is the first new sunscreen active ingredient added under the streamlined OTC monograph process established by the CARES Act.
“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” says Mike Davis, MD, PhD, acting director of the FDA Center for Drug Evaluation and Research, in a release.
DSM Nutritional Products LLC submitted the request to add bemotrizinol to the OTC sunscreen monograph. After reviewing the submission and public comments received following the proposed order, FDA issued the final order adding the ingredient.
The agency noted that OTC sunscreen products can be marketed without an approved drug application if they meet the requirements outlined in the applicable monograph, including permitted active ingredients, uses, and dosage levels.
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