The Regulatory Modernization Behind America’s Newest Sunscreen Ingredient

For more than two decades, no new active ingredient had been added to sunscreen formulations in the U.S. market. That changed in 2026 with the addition of bemotrizinol (Tinosorb S), one of the most effective broad-spectrum UV filters available worldwide.

In the United States, sunscreen has lagged behind Europe and other countries because the FDA regulates sunscreen as an over-the-counter (OTC) drug. Active sunscreen ingredients must be included in the FDA's OTC sunscreen monograph, the published standard that defines which ingredients are considered safe and effective for use in nonprescription sunscreens.

On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic 41 Security Act (CARES Act). The CARES Act modernized the over-the-counter (OTC) drug review process which means that manufacturers can submit an Over-the-Counter Monograph Order Request (OMOR) to add or modify ingredients in the published standard.

In June 2026, bemotrizinol became the first new active sunscreen ingredient added to the OTC sunscreen monograph, a considerable milestone in sunscreen innovation as a result of regulatory modernization.

Bemotrizinol matters because it provides broad-spectrum protection against UVA and UVB radiation. UVA rays contribute to skin aging and pigmentation and UVB rays cause sunburn and are a risk factor for skin cancer. Bemotrizinol is a standout ingredient because it is highly photostable, meaning it remains effective after prolonged sun exposure, it can stabilize other UV filters and it improves the overall performance of sunscreen formulas.

U.S. consumers won't see bemotrizinol immediately. Manufacturers will need to reformulate products and generate the required safety and effectiveness data to support bringing these new sunscreen formulations to market.

For those of us who follow both science and regulation, bemotrizinol is more than a new sunscreen ingredient. It demonstrates how regulatory modernization can foster innovation while maintaining standards for safety and effectiveness.