[North America] FDA Adds Bemotrizinol to Permitted Sunscreen Active Ingredients in the US

On 10 June 2026, the US Food and Drug Administration (FDA) issued a final order to amend the requirements for sunscreen drug products under the Over-The-Counter (OTC) Sunscreen Monograph.  This final order amends OTC Monograph M020 to add bemotrizinol as a sunscreen active ingredient and takes effect on 9 August 2026.

The FDA considers bemotrizinol to be Generally Recognised as Safe and Effective (GRASE) for use in sunscreens by adults and children aged six months and older, at concentrations up to 6%.

Need help navigating these changes?

Reach out to our regulatory experts for tailored guidance and support in adapting to the new requirements.

Subscribe to our newsletter to stay informed on future amendments and industry insights.

Share This Story, Choose Your Platform!

Related Posts

    • Meet Melbec: Georgina

      Published On: July 15, 2026

      Georgina is one of our fantastic Client Support Coordinators! She looks after our new customers, ensuring their onboarding experience is smooth and seamless, and that they always have a friendly point of contact whenever they [...]

    • Plastic Free July: How Microbiology and Melbec Are Helping Shape a More Sustainable Future

      Published On: July 15, 2026

      Every year, Plastic Free July invites individuals and businesses to rethink their relationship with single‑use plastics. It’s a global movement that empowers millions to reduce plastic pollution and adopt more sustainable habits. But in the [...]

    • [Canada] Amendments to Hot List

      Published On: July 14, 2026

      The following amendments have been made to Canada’s Hot List. Substance Restriction/proposition PHMB ( Polyaminopropyl Biguanide)    Restriction: (Polyhexamethylenebiguanide; Poly(hexamethylenebiguanide) hydrochloride; PHMB; Polihexanid)   Not permitted for use in spray or aerosol formulations. Max concentration for [...]