{"abstract":"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.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/06/10/2026-11578.html","cfr_references":[],"citation":"91 FR 35220","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the availability on FDA's website of the final order is published in the Federal Register on June 10, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-6494"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-06-10","updated_at":"2026-06-10T10:57:55.772-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-6494-0050","allow_late_comments":false,"id":"FDA-2025-N-6494-0050","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-6494","title":"Amending Over-the-Counter Monograph M020:  Sunscreen Drug Products for Over-the-Counter Human Use"}],"document_number":"2026-11578","effective_on":null,"end_page":35221,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/10/2026-11578.xml","html_url":"https://www.federalregister.gov/documents/2026/06/10/2026-11578/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-11578?publication_date=2026-06-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-10/2026-11578/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1325,"last_updated":"2026-07-26 04:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-10/pdf/2026-11578.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11578.pdf?1781009109","publication_date":"2026-06-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/10/2026-11578.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-N-6494","supporting_documents_count":0,"docket_id":"FDA-2025-N-6494","document_id":"FDA-2025-N-6494-0050","regulation_id_number":null,"title":"Amending Over-the-Counter Monograph M020:  Sunscreen Drug Products for Over-the-Counter Human Use","checked_regulationsdotgov_at":"2026-06-11T20:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35220,"subtype":null,"title":"Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information","toc_doc":"Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information","toc_subject":"Amending Over-the-Counter Monograph M020","topics":[],"type":"Notice","volume":91}