In June 2026, the U.S. Food and Drug Administration (FDA) updated the list of active ingredients – UV filters – permitted in sunscreen products for the first time in over 20 years.
The Agency added bemotrizinol, with a maximum permitted concentration of 6%. This marks the first new active ingredient included in the OTC sunscreen monograph since the late 1990s.
Bemotrizinol is already permitted in the European Union under Annex VI, entry 25 of the EU Cosmetics Regulation, where it may be used at concentrations of up to 10%.
This update is a part of the FDA’s broader efforts to support innovation and expand the range of available sunscreen options for consumers.
Sunscreen regulatory classification in the US
Unlike the EU, which classifies sunscreens as cosmetics, the United States regulates them as over-the-counter (OTC) drugs. In this context, the sunscreen monograph constitutes one of the two pathways for demonstrating compliance.
What are OTC monographs?
OTC monographs are regulatory instruments specific to certain categories of non-prescription drugs. They define the conditions under which a drug is considered Generally Recognized as Safe and Effective (GRASE) for its intended use. These conditions include elements such as active ingredients, indications, dosage forms, routes of administration, labelling, and testing standards for a given therapeutic category (e.g. sunscreens, acne products).
Monographs serve as one of the two primary regulatory pathways for placing a non-prescription drug on the US market. The alternative pathway is the New Drug Application (NDA) process, which is significantly more stringent and typically requires extensive supporting data, including clinical studies.
Under Section 505G of the Federal Food, Drug, and Cosmetic (FD&C) Act, OTC monograph drugs may be marketed without an approved application, provided they comply with all applicable monograph conditions and requirements.
Regulatory Updates to OTC monographs
Pursuant to Section 505G(b) of the FD&C Act, the FDA may update OTC monographs through an administrative order process. This process enables the Agency to add, remove, or modify GRASE conditions.
Administrative orders may be initiated either by the FDA itself or by an external requestor, providing a structured and flexible mechanism to keep OTC monographs aligned with scientific and regulatory developments.
Do you have questions on compliance of cosmetics and market access? Contact us here or at coslaw@obelis.net!
References
FDA (2026). FDA Expands Sunscreen Options for the First Time in 20 Years. Retrieved on 09 June 2026.
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