{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Nonprescription Sunscreen Drug Products--Safety and Effectiveness Data.\" This guidance addresses FDA's current thinking on 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 the Agency 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/2016/11/23/2016-28124.html","cfr_references":[],"citation":"81 FR 84594","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-4021"],"dockets":[],"document_number":"2016-28124","effective_on":null,"end_page":84595,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/11/23/2016-28124.xml","html_url":"https://www.federalregister.gov/documents/2016/11/23/2016-28124/nonprescription-sunscreen-drug-products-safety-and-effectiveness-data-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-28124?publication_date=2016-11-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-11-23/2016-28124/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":366,"last_updated":"2026-09-20 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-11-23/pdf/2016-28124.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-28124.pdf?1479822334","publication_date":"2016-11-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/11/23/2016-28124.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":"2016-12-13T06:00:24Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":84594,"subtype":null,"title":"Nonprescription Sunscreen Drug Products-Safety and Effectiveness Data; Guidance for Industry; Availability","toc_doc":"Nonprescription Sunscreen Drug ProductsSafety and Effectiveness Data","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}