The U.S. Food and Drug Administration today added bemotrizinol to the list of permitted sunscreen active ingredients, marking the first new addition to the over-the-counter sunscreen monograph since the late 1990s.

Bemotrizinol provides protection against both ultraviolet A and B rays and demonstrates low levels of absorption through the skin into the body. The FDA considers the ingredient generally recognized as safe and effective (GRASE) for use by adults and children 6 months of age and older.

“As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” said HHS Secretary Robert F. Kennedy, Jr. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.”

Streamlined Approval Under the CARES Act

Bemotrizinol is the first new active ingredient added to an OTC monograph under the streamlined process established by the CARES Act. The FDA finalized this action within seven months of issuing the proposed order. The ingredient has been marketed as a sunscreen ingredient in Europe and many countries around the world for years.

Today’s action aligns with the Make America Healthy Again (MAHA) Strategy Report priority: “FDA will promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries.”

How the Approval Process Worked

DSM Nutritional Products LLC submitted an OTC monograph order request to add bemotrizinol, at concentrations up to 6 percent, as a new active ingredient in the OTC monograph for sunscreens. The FDA reviewed the request and issued a proposed order on December 12, 2025, with a public comment period running through January 26, 2026. After reviewing the comments, the agency is now issuing the final order.

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.

Source: FDA Press Release