FD&C Act in response to DSM’s submission of an OMOR. In the proposed order, FDA proposed to amend OTC Monograph M020 to add bemotrizinol as a sunscreen active ingredient. FDA...
OTC MONOGRAPHS @ FDA | FDA
This final order amends OTC Monograph M020 to add bemotrizinol as a sunscreen active ingredient.
FDA Clears the Way for Bemotrizinol: First New OTC Sunscreen Active ...
Jun 16, 2026 · The proposed order deferred this question; the final order grants DSM 18 months of exclusivity from August 9, 2026 FDA received approximately 50 public comments during the …
Bemotrizinol FDA Approval - Jane Yoo MD
Jun 18, 2026 · The FDA published a proposed order in late 2025, accepted public comment, and finalized the approval on June 9, 2026. The final order allows bemotrizinol to be used in OTC …
US gets a new sunscreen molecule, bemotrizinol
On June 9, the US Food and Drug Administration issued a final order that adds bemotrizinol (BEMT) to its list of approved sunscreen ingredients and declares it to be generally recognized as safe and …
FDA Approves Bemotrizinol, First New U.S. Sunscreen Filter
Jun 10, 2026 · FDA adds bemotrizinol to OTC sunscreen monograph (up to 6%), grants DSM 18‑month exclusivity; ingredient cleared for ages 6 months and up.
FDA Sunscreen Approval - Bemotrizinol Added To OTC Monograph
Jun 16, 2026 · The FDA recently finalized an administrative order adding bemotrizinol to the OTC sunscreen monograph, making it the first new active sunscreen ingredient added to the monograph …
The Bemotrizinol Approval: What the Patent Record Tells U.S.
FDA approval adds Bemotrizinol to the US sunscreen monograph after 20 years. Learn what the patent record reveals about formulation, stabilization, and solubility for US R&D teams.
Amending Over-the-Counter Monograph M020: Sunscreen Drug …
Dec 12, 2025 · On September 23, 2024, DSM Nutritional Products LLC submitted a Tier 1 OMOR requesting FDA issue an administrative order finding that a sunscreen drug product containing …
FDA approves bemotrizinol as new sunscreen ingredient
Jun 9, 2026 · DSM will exclusively sell bemotrizinol, under the brand name Parsol Shield, in the U.S. for 18 months from when the order goes into effect on Aug. 9. After that period ends, other...