Bemotrizinol Becomes a Formulator Reality: The First New U.S. Sunscreen Active in 26 Years Is at the Final-Order Stage

On December 12, 2025, the FDA published a proposed administrative order (OTC000039) to add bemotrizinol to the U.S. sunscreen monograph (M020) at concentrations up to 6%, declaring it GRASE for adults and children six months and older. The public comment period closed January 26, 2026. As of mid-May 2026 no final order has been issued; the FDA initially flagged a March 2026 decision window but the rule remains in the final-order phase. Flag this as Building, not Strong, until finalization.

Bemotrizinol is not new science. It has been used in European, Australian, and Asian sunscreens for decades — a broad-spectrum filter with superior UVA/UVB photostability that does not degrade on sun exposure, unlike many chemical filters currently approved in the U.S. FDA Commissioner Marty Makary publicly criticized the U.S. as "too sluggish" in approving sunscreen technologies relative to peer markets. The DSM-Firmenich submission (PARSOL Shield) is what triggered the review.

For clean-positioned SPF brands — Supergoop, Vacation, Ciele, Unsun — bemotrizinol's approval would unlock a high-performance, photostable broad-spectrum filter that can replace or reduce combinations of current filters carrying systemic-absorption concerns (the FDA's 2019 Proposed Rule required additional safety data on several of them, and the EU SCCS continues to flag octinoxate, homosalate, and octocrylene for endocrine-disruption review). This is the first genuinely new chemical filter the U.S. clean-SPF category can formulate around in a generation.

Supergoop's new CEO Melis del Rey (ex-Amazon Beauty GM, appointed December 2025) arrives at the moment the U.S. SPF category is about to expand technically for the first time in decades. The watch item is sequencing: which brand ships the first U.S.-formulated bemotrizinol SKU after finalization, and whether Supergoop uses the launch to reset its formulation narrative against the K-beauty SPF brands (Beauty of Joseon, SKIN1004, COSRX) that currently dominate the photostability conversation in the U.S. clean-SPF tier.