USA: Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information
Updated on : 14-06-2026
| In response to an over-the-counter (OTC) monograph order request (OMOR), the Food and Drug Administration (FDA) is announcing the availability on its website of the final administrative order (final order) (OTC000039) titled ''Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information.'' This final order amends ''Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use'' (OTC Monograph M020) to add bemotrizinol at concentrations up to 6 percent as a sunscreen active ingredient. A sunscreen drug product containing bemotrizinol is generally recognized as safe and effective (GRASE) if it meets the conditions described in OTC Monograph M020 as amended by this final order.The announcement of the availability on FDA's website of the final order is published in the Federal Register on 10 June 2026.91 Federal Register (FR) 35220, 10 June 2026: https://www.govinfo.gov/content/pkg/FR-2026-06-10/html/2026-11578.htm https://www.govinfo.gov/content/pkg/FR-2026-06-10/pdf/2026-11578.pdfhttps://www.accessdata.fda.gov/drugsatfda_docs/omuf/order/supportDoc/OTC000039/Final_Administrative_Order.pdfThis notice of availability is identified by Docket Number FDA-2025-N-6494. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2025-N-6494/document and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. Previous actions notified under the symbol G/TBT/N/USA/1443 are identified by Docket Numbers FDA-1978-N-0018 and FDA-2025-N-6494 |
Most Recent Announcements
Search All Announcements
National Enquiry Point for Trade
Click here to submit queryWomen Entrepreneurs Networking Platform
Click here to visit WENPMember Area
Search this Site
Contents
Download Trade Portal Apps
Search Trade Information
Import Resources
Feature Information for Entrepreneur
Follow Us
Upcoming Events