FDA Endorses Bemotrizinol Amid Push for Modernized OTC and Sunscreen Standards

Today (Dec. 11, 2025), the U.S. Food and Drug Administration (FDA) announced a proposal to add bemotrizinol as a permitted active ingredient in over-the-counter (OTC) sunscreen products. Bemotrizinol, a UV filter used widely internationally, provides broad-spectrum protection against both UVA and UVB rays. The FDA’s review found the ingredient has low absorption through the skin, minimal risk of irritation and meets safety and effectiveness standards. 

If finalized, this proposal would expand the range of active ingredients considered generally recognized as safe and effective (GRASE) for use in sunscreens by adults and children six months of age and older.

FDA Commissioner Marty Makary, Ph.D., emphasized the importance of this initiative, stating, “The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products.”

Legislative Reforms Pave the Way for Innovation

This announcement aligns with broader legislative reforms under H.R. 5371, passed by the Senate on Nov. 10, 2025, which modernizes the OTC drug monograph system. These changes aim to streamline the approval process for new sunscreen ingredients, reduce development timelines and align U.S. standards more closely with global practices.

Karen Murry, M.D., acting director of the Office of Nonprescription Drugs, noted that reforms under the Coronavirus Aid, Relief and Economic Security (CARES) Act have significantly improved the regulatory process for OTC drugs. “Bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers,” she said.

Advocacy Highlights the Need for Change

DSM-Firmenich, in collaboration with the Personal Care Products Council, has been a vocal advocate for these reforms. In recent congressional testimony, the company highlighted the urgent need to address the slow FDA approval process and limited access to advanced UV filters. 

The company's advocacy emphasized the importance of modernized standards to combat skin cancer, the fastest-growing cancer in the United States. The testimony also underscored the potential for innovative sunscreen formulations that are more inclusive and aesthetically appealing for all skin types.

Modifying the OTC Monograph

According to the FDA, 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 (proposed and final), and a drug company may start the process by submitting an OTC Monograph Order Request (OMOR).

Within this context, in October 2024, DSM Nutritional Products, LLC, had submitted a request that the FDA add bemotrizinol, at concentrations up to 6%, as a new active ingredient in the OTC monograph for sunscreens.

Next Steps and Comprehensive Protection

The FDA is now seeking public comments on the proposed order before issuing a final decision. For more information or to submit comments, visit the FDA’s OTC Monographs portal.

In addition, the FDA continues to emphasize the importance of sunscreen use as part of a comprehensive approach to sun protection, which includes wearing protective clothing and limiting sun exposure. Broad-spectrum sunscreens with SPF 15 or higher are recognized as effective in preventing sunburn, reducing the risk of skin cancer and slowing early skin aging caused by the sun.