FDA Adds Bemotrizinol as First New Sunscreen Ingredient in Decades

The US Food and Drug Administration (FDA) has finalized an order including bemotrizinol as a permitted active ingredient in its list of over-the-counter (OTC) sunscreen products approved for skin cancer protection, marking the first addition of a new active ingredient to the OTC sunscreen monograph since the late 1990s.^1,2

Released on June 9, the announcement by FDA officials highlights bemotrizinol’s newfound inclusion in the list of sunscreen products marketed in the US under the OTC monograph framework, with related products being required still to meet established conditions and formulation rules. Bemotrizinol, implemented previously in Europe and other international markets, is designed to provide broad-spectrum protection against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation.²

“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,” US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said in a statement.¹

According to the agency, the ingredient has demonstrated low levels of systemic absorption through users’ skin and is considered generally recognized to be both safe and effective (GRASE) for implementation in sunscreen products in adults and children aged 6 months and older. The FDA's final order allows bemotrizinol at concentrations of up to 6%.

The decision by FDA officials represents a notable regulatory milestone, as it is the first new sunscreen active ingredient included in an OTC monograph under the streamlined review process established via the Coronavirus Aid, Relief, and Economic Security (CARES) Act.¹ The legislation allowed for a new administrative framework for updating OTC drug monographs, replacing the prior rulemaking process.

Federal officials highlighted the move by the FDA as an example of efforts to accelerate innovation while maintaining regulatory standards for products’ safety and effectiveness. Mike Davis, MD, PhD, who serves as acting director for the FDA’s Center for Drug Evaluation and Research (CDER), similarly pointed the agency’s commitment to modernizing regulatory pathways while ensuring access to safe and effective products.

Under the OTC monograph system, products shown to comply with monograph conditions, including approved levels of dosage, active ingredients, labeling requirements, and indications, may be marketed without the submission and approval of a new drug application.

This new decision to add bemotrizinol comes amid broader discussions related to sunscreen innovation within the US, where a variety of ultraviolet filters accessible internationally have not been permitted for consumers. By including bemotrizinol in the OTC sunscreen monograph, FDA officials sought to step toward expanding available sunscreen technologies while signaling a willingness to utilize the CARES Act framework.¹

“The FDA’s rigorous standards ensure consumers can be confident in the sunscreens and other nonprescription drugs they use,” Karen Murry, MD, director of the Office of Nonprescription Drugs in CDER, said in a statement.¹ “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.”

References

1. FDA expands sunscreen options for the first time in 20 years. News release. US Food and Drug Administration. 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.