Bemotrizinol Enters the U.S. Sunscreen Monograph. Products Still Need Testing.
FDA added bemotrizinol to the U.S. OTC sunscreen monograph. Its permitted use sets conditions for product development; it does not establish the SPF of a finished formula.
A new option for U.S. sunscreen formulas
In June 2026, the U.S. FDA added bemotrizinol (BEMT) to its over-the-counter sunscreen monograph. It was the first new sunscreen active ingredient added to that monograph since the late 1990s. The order took effect on August 9, subject to the statutory dispute provision. BEMT had already been used in sunscreens in Europe and other markets, but U.S. use required its own regulatory review. [1, 2]
FDA evaluated two independent human efficacy studies alongside nonclinical, clinical pharmacology and safety evidence. Under the order’s conditions, BEMT may be used at concentrations up to 6% in sunscreen products intended for adults and children aged six months or older. Six percent is a ceiling, not a target for every formula. [1]
An ingredient decision is not a product result
The order specifies permitted concentrations, combinations and dosage forms. It does not approve a particular finished sunscreen. A product marketed under the monograph must meet its applicable conditions, including finished-product SPF testing. Broad-spectrum and water-resistance claims have their own test and labeling requirements. [1]
That distinction matters when a team moves from active selection to a usable formula. BEMT can add a new option to the ingredient set; the protection stated on a label comes from testing the actual product. FDA also notes that manufacturers determine when products containing the ingredient reach retail shelves. [3]
The development question moves to the formula
For a development team, the next questions concern the intended format, permitted ingredient combinations, stability, application and final testing. None can be answered by the ingredient’s inclusion in the monograph alone. The regulatory change opens a route for eligible products; each finished formula must still demonstrate the performance it claims under the applicable U.S. rules.
Sources
- U.S. Food and Drug Administration. Final Administrative Order OTC000039: Amending Over-the-Counter Monograph M020. June 2026.
- U.S. Food and Drug Administration. FDA Expands Sunscreen Options for the First Time in 20 Years. June 9, 2026.
- U.S. Food and Drug Administration. Sunscreen: How to Help Protect Your Skin from the Sun.