FDA Expands Sunscreen Options for the First Time in 20 Years

The U.S. Food and Drug Administration (FDA) has added bemotrizinol to the list of approved active ingredients for over-the-counter (OTC) sunscreen products, marking the first update of this kind in more than two decades and a significant step forward for sunscreen innovation in the United States.

Bemotrizinol is the first new sunscreen active ingredient included in the OTC sunscreen monograph since the late 1990s.

“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.”

The FDA completed the review and final action within seven months of issuing the proposed order. Bemotrizinol has been widely used as a sunscreen ingredient in Europe and other international markets for years.

“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Mike Davis, M.D., Ph.D., Acting Director of the FDA Center for Drug Evaluation and Research (CDER). “The FDA is committed to ensuring that American consumers have access to safe and effective therapies, including over-the-counter products such as sunscreens.”

Bemotrizinol provides broad-spectrum protection against both UVA and UVB radiation and demonstrates low skin absorption. The FDA has determined it to be generally recognized as safe and effective (GRASE) for use in sunscreens for adults and children aged six months and older.

This marks the first new active ingredient added to an OTC monograph through the streamlined process established under the CARES Act. The decision also supports priorities outlined in the Make America Healthy Again (MAHA) Strategy Report, which calls for modernizing and accelerating sunscreen innovation in the United States.

“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” said Karen Murry, M.D., Director of the Office of Nonprescription Drugs in CDER. “With updated science and regulatory frameworks, we can now work with industry to bring innovative products to market more efficiently than ever before.”

OTC monograph drugs, including sunscreen products, can be marketed without an approved drug application if they comply with established monograph conditions such as permitted active ingredients, dosage, and intended use. The FDA may revise these monographs through administrative orders, and companies may initiate updates through OTC monograph order requests.

In this case, DSM Nutritional Products LLC submitted a request to include bemotrizinol at concentrations of up to 6% as an active sunscreen ingredient. Following FDA review, a proposed order was issued on December 12, 2025, and opened for public comment until January 26, 2026. After evaluating feedback, the FDA has now finalized the order.