The FDA just approved a sunscreen ingredient other countries have used for years

The FDA published a final order on June 10 adding bemotrizinol to the list of active ingredients legally permitted in over-the-counter sunscreens sold in the United States — a UV filter that has been available in sunscreens elsewhere in the world for years [s1].

What the order does

Final order OTC000039 amends OTC Monograph M020, the FDA's governing rulebook for what counts as a "generally recognized as safe and effective" over-the-counter sunscreen, to add bemotrizinol as a permitted active ingredient at concentrations up to 6 percent [s1]. The order specifies which product forms bemotrizinol-containing sunscreens can take — oil, lotion, cream, gel, butter, paste, ointment, stick, and spray — with a specific safety condition on spray products: they must either contain no propellant or be packaged so that any propellant is fully isolated from the sunscreen formulation, with no contact between the two inside the container [s1].

How long this took

The regulatory path here stretches back further than the formal request that triggered this specific order. FDA records show bemotrizinol was already the subject of agency feedback under the Sunscreen Innovation Act as far back as November 13, 2014, when the agency issued an initial determination letter on safety and effectiveness data for the ingredient [s2]. The request that led directly to this year's approval came later: DSM Nutritional Products LLC submitted a formal Tier 1 monograph order request on September 23, 2024, asking the FDA to find that a sunscreen product containing bemotrizinol met the safe-and-effective standard [s1]. FDA published a proposed order in December 2025, took public comment, made no changes in response to those comments, and finalized the order this month [s1].

Why this matters for sunscreen shoppers

Bemotrizinol is a broad-spectrum UV filter, meaning it's designed to absorb both UVA and UVB radiation, and formulations containing it have been sold in European and other international markets for years under different regulatory regimes. Its addition to the US list matters because American sunscreen formulations have operated for years under a comparatively narrow set of FDA-approved active ingredients relative to what's available in some other markets — a gap that has been a recurring point of criticism from dermatologists and sunscreen chemists. This order doesn't retroactively change any product currently on shelves; it establishes the regulatory pathway that would let a manufacturer bring a bemotrizinol-containing sunscreen to the US market going forward, since a product still needs to actually be formulated, manufactured, and brought to market under the new conditions before it reaches shoppers.

What the order does not establish

The FDA's order is a regulatory determination that bemotrizinol, used within the specified concentration and formulation conditions, is generally recognized as safe and effective as a sunscreen active ingredient [s1] — it is not, on its own, a guarantee about how quickly bemotrizinol-containing products will actually appear on US shelves, nor does the order itself detail the specific safety and efficacy data DSM Nutritional Products submitted in support of the request. The full supporting record is housed on FDA's OTC Monographs portal rather than in the Federal Register notice itself [s1].