{"abstract":"We (Food and Drug Administration or FDA) are asking sunscreen manufacturers and other interested parties to submit data on over-the- counter (OTC) sunscreen drug products marketed without approved applications that are formulated in certain dosage forms. These data are necessary to address questions about these dosage forms. For spray dosage forms, we are requesting data to resolve specific questions about both effectiveness and safety. We are also inviting comment on possible labeling and testing requirements for spray dosage forms. This information will be used in establishing monograph conditions, including dosage forms, for sunscreens that are generally recognized as safe and effective (GRASE) and not misbranded.","action":"Advance notice of proposed rulemaking; request for data and information.","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/2011/06/17/2011-14768.html","cfr_references":[{"chapter":null,"citation_url":null,"part":352,"title":21}],"citation":"76 FR 35669","comment_url":null,"comments_close_on":"2011-09-15","correction_of":null,"corrections":[],"dates":"Submit data and information either electronically or in writing by September 15, 2011.","disposition_notes":null,"docket_ids":["Docket No. FDA-1978-N-0018","formerly Docket No. 1978N-0038"],"dockets":[],"document_number":"2011-14768","effective_on":null,"end_page":35672,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/06/17/2011-14768.xml","html_url":"https://www.federalregister.gov/documents/2011/06/17/2011-14768/sunscreen-drug-products-for-over-the-counter-human-use-request-for-data-and-information-regarding","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-14768?publication_date=2011-06-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-06-17/2011-14768/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1232,"last_updated":"2026-08-25 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/2011-14768.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-06-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/06/17/2011-14768.txt","regulation_id_number_info":{"0910-ZA40":null},"regulation_id_numbers":["0910-ZA40"],"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":"2011-07-07T08:07:56Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35669,"subtype":null,"title":"Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms","toc_doc":"Sunscreen Drug Products for Over-the-Counter Human Use; Dosage Forms","toc_subject":null,"topics":[],"type":"Proposed Rule","volume":76}