Site Editor
Soo Park, MD
Soo Park, MD
Posted: Tuesday, June 9, 2026
On June 9, the U.S. Food and Drug Administration (FDA) added bemotrizinol to the list of permitted sunscreen active ingredients. Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.
The FDA finalized this action within 7 months of issuing the proposed order. The new ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years.
Bemotrizinol provides protection against both ultraviolet A and B rays and has low levels of absorption through the skin into the body. The FDA considers bemotrizinol to be generally recognized as safe and effective for use in sunscreens by adults and children 6 months of age and older.
Bemotrizinol is the first new active ingredient added to an OTC monograph under the streamlined process established by the CARES Act. An OTC monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements, including conditions established in its monograph such as permitted active ingredients, uses, and doses. The FDA can modify an OTC monograph through an administrative order, and a drug company may start the process by submitting an OTC monograph order request. DSM Nutritional Products LLC submitted an OTC monograph order request to add bemotrizinol, at concentrations up to 6%, as a new active ingredient in the OTC monograph for sunscreens. The FDA reviewed the request and proposed to amend the OTC monograph to add bemotrizinol as a sunscreen active ingredient. The agency issued a proposed order on December 12, 2025, to this effect, and the public could submit comments from December 12, 2025, through January 26, 2026. The agency reviewed public comments on the proposed order and is now issuing the final order.
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