FDA adds
FDA adds a new sunscreen ingredient
The final order lets sunscreen makers use bemotrizinol at up to 6% under OTC Monograph M020. Companies can use it in several dosage forms, including lotions, sticks and sprays with the propellant kept separate from the drug formula.
FDA has amended OTC Monograph M020 to add bemotrizinol as a permitted sunscreen active ingredient at concentrations up to 6%. Products still have to meet the monograph’s conditions to be considered generally recognized as safe and effective, or GRASE.
- Bemotrizinol is now allowed in U.S. OTC sunscreens at up to 6%
- Products still have to meet OTC Monograph M020 conditions to be GRASE
- The change may expand sunscreen formulas, but not overnight
- FDA announced final order OTC000039 on June 10, 2026
- The Food and Drug Administration has added bemotrizinol to its federal sunscreen rulebook, giving U.S
The Food and Drug Administration has added bemotrizinol to its federal sunscreen rulebook, giving U.S. formulators another active ingredient they can use in over-the-counter products. FDA said its final administrative order OTC000039 is now available on its website, and the change amends OTC Monograph M020 for sunscreen drug products for over-the-counter human use.
In plain terms, bemotrizinol is now a permitted sunscreen active ingredient at concentrations up to 6%. A product containing it still has to meet the monograph’s conditions to be generally recognized as safe and effective, or GRASE.
A wider ingredient kit for formulators
OTC Monograph M020 is the federal standard that governs over-the-counter sunscreen drug products for human use. The amendment gives manufacturers more room to build formulas around different textures and product types, including oil, lotion, cream, gel, butter, paste, ointment, stick and spray.
For sprays, the propellant has to remain separated from the drug formula inside the package. That kind of detail matters to the companies that design, test and package sunscreen, because a new permitted ultraviolet filter can change how a formula behaves on the shelf and on skin.
What shoppers may notice later
For consumers, the effect is likely to be gradual. The order gives sunscreen makers another legal ingredient to work with, but it does not force them to reformulate immediately or guarantee a visible change in store brands right away.
The practical result is more flexibility for future products, not a sudden overhaul of the sunscreen aisle. If companies use the new ingredient, shoppers may eventually see more choices in texture, feel and formulation.