The US Food and Drug Administration (FDA) has approved bemotrizinol as a new active ingredient for over-the-counter (OTC) sunscreens, marking the first addition to the agency’s sunscreen monograph in more than 20 years.
Widely used in Europe and several other countries, bemotrizinol offers protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays. The FDA said the ingredient has low absorption through the skin and has been determined to be generally recognized as safe and effective (GRASE) for adults and children aged six months and older.
Bemotrizinol is the first new active ingredient added to the OTC sunscreen monograph since the late 1990s, a move the FDA described as a significant step forward in advancing sunscreen innovation.
“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, Acting Director of the FDA Center for Drug Evaluation and Research (CDER).
He added that the agency is committed to ensuring American consumers have access to safe and effective therapies, including over-the-counter products such as sunscreens.
Bemotrizinol becomes the first new active ingredient added to an OTC monograph under the streamlined process established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The approval also aligns with priorities outlined in the Trump administration’s Make America Healthy Again (MAHA) Strategy Report, which calls for greater innovation and more efficient regulation in the sunscreen market.
“FDA will promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries,” the MAHA Strategy Report stated.
US Health and Human Services Secretary Robert F. Kennedy Jr. said the FDA’s action will increase competition in sunscreen products.
“As promised in the Trump Administration’s MAHA Strategy Report, HHS is advancing innovation by bringing a new sunscreen ingredient to the US market for the first time in 20 years. Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products,” he said.
The FDA completed its review within seven months of issuing a proposed order in December 2025.
DSM Nutritional Products LLC submitted a request to add bemotrizinol, at concentrations up to 6 per cent, as a new active ingredient in the OTC sunscreen monograph. The FDA reviewed the request and proposed amending the OTC monograph to include bemotrizinol as a sunscreen active ingredient.
The agency issued a proposed order on December 12, 2025, and invited public comments until January 26, 2026. After reviewing the feedback received, the FDA issued the final order.
Karen Murry, Director of the Office of Nonprescription Drugs within CDER, said the FDA’s rigorous standards ensure consumers can be confident in the safety and effectiveness of sunscreens and other nonprescription medicines.
She added that the updated regulatory framework allows the agency to work more efficiently with companies to bring innovative products to market.
An OTC monograph drug, such as a sunscreen product, can be marketed without an approved drug application if it meets specific requirements, including conditions related to permitted active ingredients, uses and dosages established in its monograph. The FDA can modify an OTC monograph through an administrative order, and companies can initiate the process by submitting an OTC monograph order request.
