WASHINGTON, D.C. — The U.S. Food and Drug Administration has authorized bemotrizinol for use in over-the-counter sunscreens, clearing the first new sunscreen active ingredient for the U.S. market in more than two decades and potentially expanding options available to manufacturers and consumers.
The action marks the first addition to the OTC sunscreen monograph since the late 1990s and represents the first new sunscreen ingredient approved through the administrative review framework established under the CARES Act.
Federal health officials framed the decision as part of a broader effort to modernize regulation of nonprescription products and bring ingredients already used internationally into the U.S. market.
Bemotrizinol provides protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays and has been used in Europe and other international markets for years. The FDA determined the ingredient is generally recognized as safe and effective for use in sunscreens by adults and children six months of age and older.
HHS Secretary Robert F. Kennedy Jr. characterized the move as an effort to expand competition within the sunscreen market, noting that bemotrizinol has a long history of use outside the United States.
The FDA completed its review less than seven months after issuing a proposed order in December 2025. Public comments were accepted through January 26, 2026, before the agency issued its final determination.
Mike Davis, acting director of the FDA’s Center for Drug Evaluation and Research, called the decision an example of how regulatory modernization can accelerate consumer access to new products while maintaining scientific review standards.
According to the FDA, bemotrizinol demonstrates low levels of absorption through the skin into the body and can be used at concentrations of up to 6% in sunscreen formulations.
The review originated from a monograph order request submitted by DSM Nutritional Products LLC seeking to add bemotrizinol to the federal sunscreen monograph. After evaluating the scientific data and public comments, the agency finalized the amendment.
The decision aligns with federal efforts to update the over-the-counter sunscreen framework, an area that industry groups and consumer advocates have long argued has lagged behind regulatory systems in Europe and other international markets.
Karen Murry, director of the FDA’s Office of Nonprescription Drugs, noted that the updated regulatory framework allows the agency to evaluate and authorize new nonprescription products more efficiently while maintaining existing safety standards.
Under federal law, products covered by an OTC monograph may be marketed without a separate drug approval application if they comply with the conditions established within the monograph, including approved active ingredients, uses and dosage requirements.
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