FDA Accepts Addition of Bemotrizinol as First New Sunscreen Ingredient in 20 Years

The FDA has approved bemotrizinol as a permitted active ingredient in over-the-counter (OTC) sunscreen products, according to a June 9, 2026, agency announcement.¹ The action marks the first addition to the OTC sunscreen monograph since the late 1990s and makes bemotrizinol the first new sunscreen active ingredient added through the streamlined administrative order process established by the CARES Act. The ingredient is approved for use in adults and children 6 months of age and older.¹

The FDA issued a proposed order on December 11, 2025, with a public comment period closing January 26, 2026.^1,2 DSM Nutritional Products LLC submitted the OTC Monograph Order Request to add bemotrizinol at concentrations up to 6% as a new active ingredient, and the FDA finalized the action within 7 months of issuing the proposed order.¹

"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, MD, PhD, acting director of the FDA Center for Drug Evaluation and Research, in the news release. “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”¹

Bemotrizinol: UV Spectrum Coverage, Absorption Profile, and GRASE Determination

Bemotrizinol provides broad-spectrum protection against both ultraviolet A and ultraviolet B rays.¹ The ingredient has low levels of absorption through the skin into the body and rarely causes skin irritation, according to the FDA's review of available data.^1,2 Based on this review, the FDA considers bemotrizinol generally recognized as safe and effective (GRASE) for OTC sunscreen use.¹

The proposed order issued in December 2025 described bemotrizinol as an ingredient marketed in sunscreen products across Europe and numerous other countries for years prior to US regulatory action.² The FDA had not previously approved a drug application or added the ingredient to the sunscreen monograph before this action.² Concentrations up to 6% are permitted under the final order.¹

Regulatory Pathway and OTC Monograph Process

Under the OTC monograph framework, a sunscreen product can enter the US market without an approved new drug application if it meets conditions set in the monograph, including permitted active ingredients, uses, and doses. The FDA can modify a monograph through an administrative order process, which a manufacturer initiates by submitting an OTC Monograph Order Request. The CARES Act streamlined this process, enabling faster review cycles than prior regulatory pathways allowed.^1,2

“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” said Karen Murry, MD, Director of the Office of Nonprescription Drugs in CDER, in the news release. “Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before.”¹

In the December 2025 proposed order announcement, Murry described bemotrizinol as "a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers."²

Dermatology clinicians may encounter patients and industry inquiries related to new sunscreen formulations containing bemotrizinol as manufacturers begin incorporating the ingredient. The ingredient's broad-spectrum coverage profile and low skin absorption may be relevant for patient counseling on sunscreen selection, particularly in populations where tolerability and efficacy across UV wavelengths are priorities.

“Advances around sunscreen and skin cancer prevention are always welcome. Such progress helps our patients by expanding the options from which they can choose; that, by default, will increase compliance and use," Mona Gohara, MD, board-certified dermatologist and associate clinical professor of dermatology at the Yale School of Medicine, told Dermatology Times.

References

1. FDA expands sunscreen options for the first time in 20 years. News release. US Food and Drug Administration. June 9, 2026. Accessed June 9, 2026. https://www.fda.gov/news-events/press-announcements/fda-expands-sunscreen-options-first-time-20-years
2. FDA proposes expanding sunscreen active ingredient list. News release. US Food and Drug Administration. December 11, 2025. Accessed June 9, 2026. https://www.fda.gov/news-events/press-announcements/fda-proposes-expanding-sunscreen-active-ingredient-list

Frequently Asked Questions

What is bemotrizinol and how does it work in sunscreens?

Bemotrizinol is a broad-spectrum UV filter providing protection against both ultraviolet A and B rays. The FDA approved its addition to the OTC sunscreen monograph at concentrations up to 6% following a review showing low skin absorption and a low rate of skin irritation.

Is bemotrizinol safe for pediatric patients?

The FDA determined bemotrizinol to be GRASE for use in adults and children 6 months of age and older, consistent with labeling standards for other approved OTC sunscreen active ingredients.

How is bemotrizinol added to the OTC monograph different from a standard drug approval?

OTC monograph products do not require an approved new drug application. Instead, manufacturers submit an OTC Monograph Order Request and the FDA reviews it through the administrative order process established under the CARES Act. The final order amending the sunscreen monograph is what enables commercial marketing.