{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Over-the- Counter Sunscreens: Safety and Effectiveness Data.\" This draft guidance addresses FDA's current thinking about the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future.","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/2015/11/23/2015-29636.html","cfr_references":[],"citation":"80 FR 72975","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 22, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-4021"],"dockets":[],"document_number":"2015-29636","effective_on":null,"end_page":72976,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/11/23/2015-29636.xml","html_url":"https://www.federalregister.gov/documents/2015/11/23/2015-29636/over-the-counter-sunscreens-safety-and-effectiveness-data-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-29636?publication_date=2015-11-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-11-23/2015-29636/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1855,"last_updated":"2026-10-25 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-11-23/pdf/2015-29636.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-29636.pdf?1448027120","publication_date":"2015-11-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/11/23/2015-29636.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-4021","supporting_documents_count":0,"docket_id":"FDA-2015-D-4021","regulation_id_number":null,"title":"Over-the-Counter Sunscreens:  Safety and Effectiveness Data","checked_regulationsdotgov_at":"2016-01-23T05:01:28Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":72975,"subtype":null,"title":"Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability","toc_doc":"Over-the-Counter SunscreensSafety and Effectiveness Data","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}