FDA adds a new sunscreen ingredient

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.