Bemotrizinol Sunscreen: What Order OTC000039 Permits

Bemotrizinol sunscreen, under the US order that permits the ingredient, is a finished product containing it at up to and including 6 percent. The FDA calls that product generally recognized as safe and effective only when it meets the amended sunscreen monograph. Broad spectrum, SPF, and water-resistance minutes are a separate reading of the bottle, already set out in physical vs chemical sunscreen.

What did FDA order OTC000039 change about bemotrizinol sunscreen?

Final order OTC000039 was issued on June 10, 2026, and corrected on August 10, 2026. The Federal Register notice of the order says a product with this ingredient is GRASE on one condition: A sunscreen drug product containing bemotrizinol is generally recognized as safe and effective (GRASE) if it meets the conditions described in OTC Monograph M020 as amended by this final order.

The bemotrizinol 6 percent line means a concentration up to 6 percent, and the order's footnote reads that phrase as up to and including 6 percent. The dosage forms in the same determination are oil, lotion, cream, gel, butter, paste, ointment, stick, or spray. A spray counts only when it is made with no propellant, or when any propellant stays isolated inside the package so it never touches the formula. The order calls these conditions necessary for the GRASE finding, and it also says they are not sufficient on their own. Other sourced ceilings on this site are collected in skincare numbers.

A combination is where the permission narrows. The order finds that a drug product is not GRASE if it includes bemotrizinol together with PABA, trolamine salicylate, or both. A finished product that uses the ingredient also has to provide a minimum SPF of not less than 2 on the monograph's test. That figure is a floor written into the order. The way to read an SPF number on a bottle is the account on the sunscreen page above.

When does the order take effect, and who may sell a bemotrizinol sunscreen?

Section VI of the corrected order states that it shall take effect (a) August 9, 2026; or (b) if the final order is disputed under section 505G(b) of the FD&C Act, in accordance with section 505G(b)(2)(A)(iv)(I) of such Act.

Bemotrizinol sunscreen brands, in this order, are a company name. Section V says the order authorizes solely DSM Nutritional Products LLC, or the licensees, assignees, or successors in interest of DSM with respect to this order, to market the change. The exclusivity lasts 18 months following the effective date, and it begins on the date DSM may lawfully market drugs under the order.

Is bemotrizinol safe for children?

The order's finding covers adults and children 6 months of age and older. In the same response the FDA says the pediatric data for bemotrizinol are limited, and that it does not treat that limit as a safety gap. The clinical pharmacology data submitted with the request showed that bemotrizinol is not readily absorbed through human skin, even with repeat application.

For children under 6 months of age, the monograph's labeling line is to ask a doctor.

The conditions, in one place

FAQ

What is bemotrizinol? A sunscreen active ingredient that final order OTC000039 permits in a US over-the-counter sunscreen at up to and including 6 percent, when the finished product meets the amended monograph.

Is bemotrizinol FDA approved? OTC000039 amends the sunscreen monograph, and it is the route for marketing a product without an approved application under section 505 of the Food, Drug, and Cosmetic Act. A sunscreen that contains bemotrizinol is GRASE if it meets OTC Monograph M020 as amended by that order. The order describes the conditions it lists as necessary, and not sufficient on their own. For 18 months it authorizes DSM Nutritional Products LLC, or that company's licensees, assignees, or successors, to market the change.

What percentage of bemotrizinol is allowed? Up to and including 6 percent in the drug product. The footnote is what closes the phrase "up to," and the percentage sits with the other conditions in the table, not as a number by itself.

Can I use bemotrizinol sunscreen on a baby? The order's population is adults and children 6 months of age and older. For a child under 6 months of age, the labeling line in the monograph is to ask a doctor.

A bemotrizinol sunscreen bottle is still read the way any sunscreen bottle is read: broad spectrum, the SPF number, and the water-resistance minutes, on the page linked above. The percentage on that bottle is read against the 6 percent ceiling, and against the rest of order OTC000039.