Federal Register #OTC000039

FDA Amends OTC Monograph to Add Bemotrizinol as Sunscreen Ingredient

This notice announces a regulatory update from the Food and Drug Administration (FDA) regarding sunscreen ingredients. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - DSM Nutritional Products LLC (noted as the OMOR submitter) - Products/Services Requested: - No procurement of products or services is requested - Amendment to OTC Monograph M020 to add bemotrizinol as a sunscreen active ingredient (up to 6%) - Permitted dosage forms: oil, lotion, cream, gel, butter, paste, ointment, stick, spray (with packaging requirements for sprays) - Unique or Notable Requirements: - Bemotrizinol-containing sunscreens must meet all conditions specified in the amended monograph to be considered GRASE (Generally Recognized as Safe and Effective) - Minor stylistic and formatting changes to the monograph for clarity - No contract, purchase, or solicitation for goods or services is included in this notice

Description

The Food and Drug Administration (FDA) announces the availability of the final administrative order OTC000039 which amends Over-the-Counter Monograph M020 to add bemotrizinol at concentrations up to 6% as a sunscreen active ingredient. This amendment recognizes sunscreen drug products containing bemotrizinol as generally recognized as safe and effective (GRASE) if they meet specified conditions. The final order also specifies permitted dosage forms and conditions for marketing such products without an approved application. Minor stylistic and formatting changes were also made to improve clarity and presentation of the monograph.

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