{"abstract":"The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that amends the tentative final monograph (proposed rule) for over-the-counter (OTC) sunscreen drug products. This amendment would establish conditions under which products containing zinc oxide as a sunscreen active ingredient are generally recognized as safe and effective and not misbranded at concentrations of up to 25 percent alone and 2 to 25 percent in combination with any proposed Category I sunscreen active ingredient except avobenzone. OTC marketing of such drug products is being permitted pending establishment under the OTC drug review of a final monograph covering sunscreen drug products. This proposal is part of the ongoing review of OTC drug products conducted by FDA.","action":"Notice of proposed rulemaking.","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/1998/10/22/98-28274.html","cfr_references":[{"chapter":null,"citation_url":null,"part":352,"title":21}],"citation":"63 FR 56584","comment_url":null,"comments_close_on":"1999-01-20","correction_of":null,"corrections":[],"dates":"Submit written comments by January 20, 1999; written comments on the agency's economic impact determination by January 20, 1999. FDA is proposing that any final rule based on this proposal become effective 12 months after its date of publication in the Federal Register.","disposition_notes":null,"docket_ids":["Docket No. 78N-0038"],"dockets":[],"document_number":"98-28274","effective_on":null,"end_page":56589,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1998/10/22/98-28274/sunscreen-drug-products-for-over-the-counter-human-use-amendment-to-the-tentative-final-monograph","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/98-28274?publication_date=1998-10-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1998-10-22/98-28274/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":116,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1998-10-22/pdf/98-28274.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1998-10-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1998/10/22/98-28274.txt","regulation_id_number_info":{"0910-AA01":{"issue":"200310","html_url":"https://www.federalregister.gov/regulations/0910-AA01/over-the-counter-otc-drug-review","title":"Over-the-Counter (OTC) Drug Review","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200310&RIN=0910-AA01&operation=OPERATION_EXPORT_XML","priority_category":"Routine and Frequent"}},"regulation_id_numbers":["0910-AA01"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 210 - Yiin_2015_Assessment of Dermal Absorption of DEET-Containing Insect Repellent and Oxybenzone-Containing Sunscreen","document_id":"FDA-1978-N-0018-1051"},{"title":"Reference 190 - EPA_Using Insect Repellents Safely and Effectively","document_id":"FDA-1978-N-0018-1031"},{"title":"Reference 185 - Kong_2015_Assessment of Consumer Knowledge of New Sunscreen Labels","document_id":"FDA-1978-N-0018-1026"},{"title":"Reference 180 - TGA_2016_Australian regulatory guidelines for sunscreens","document_id":"FDA-1978-N-0018-1021"},{"title":"Reference 179 - Fourtanier_2008_Sunscreens containing the BS UVA absorber prevent cutaneous detrimental effects of UV exposure","document_id":"FDA-1978-N-0018-1020"},{"title":"Reference 169 - Damian_2011_An action spectrum for UV radiation-induced immunosuppression in humans","document_id":"FDA-1978-N-0018-1010"},{"title":"Reference 154 - Liu_2018_Particle Size Distribution Analysis of OTC Aerosol or Powder Drug Products with Potential for Inhalation Exposure","document_id":"FDA-1978-N-0018-1004"},{"title":"Reference 153 - Liu_2017_Particle Size Distribution Analysis of OTC Drug Products with Unintended Inhalation Exposure to Consumers","document_id":"FDA-1978-N-0018-0994"},{"title":"Reference 152 - Brown_2013_Thoracic and Respirable Particle Definitions for Human Health Risk Assessment","document_id":"FDA-1978-N-0018-0993"},{"title":"Reference 148 - Stuart_1984_Deposition and Clearance of Inhaled Particles","document_id":"FDA-1978-N-0018-0989"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AF43/sunscreen-drug-products-for-over-the-counter-human-use-final-monograph-","title":"Sunscreen Drug Products For Over-The-Counter-Human Use; Final Monograph\n"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1978-N-0018","supporting_documents_count":325,"docket_id":"FDA-1978-N-0018","regulation_id_number":"0910-AF43","title":"Sunscreen Drug Products -OPEN","checked_regulationsdotgov_at":"2019-07-26T03:30:07Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":56584,"subtype":null,"title":"Sunscreen Drug Products for Over-the-Counter Human Use; Amendment to the Tentative Final Monograph; Enforcement Policy","toc_doc":null,"toc_subject":null,"topics":[],"type":"Proposed Rule","volume":63}