{"abstract":"The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).","action":"Final rule.","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/2011/06/17/2011-14766.html","cfr_references":[{"chapter":null,"citation_url":null,"part":201,"title":21},{"chapter":null,"citation_url":null,"part":310,"title":21}],"citation":"76 FR 35620","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":["https://www.federalregister.gov/api/v1/documents/C1-2011-14766"],"dates":"Effective Date: This final rule is effective June 18, 2012. For additional information concerning this effective date, see section X in the preamble of this document. The incorporation by reference of a certain publication listed in this rule is approved by the Director of the Federal Register as of June 18, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-1978-N-0018"],"dockets":[],"document_number":"2011-14766","effective_on":"2012-06-18","end_page":35665,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/06/17/2011-14766.xml","html_url":"https://www.federalregister.gov/documents/2011/06/17/2011-14766/labeling-and-effectiveness-testing-sunscreen-drug-products-for-over-the-counter-human-use","images":{"ER17JN11.009":{"large":"https://img.federalregister.gov/ER17JN11.009/ER17JN11.009_large.png","medium":"https://img.federalregister.gov/ER17JN11.009/ER17JN11.009_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.009/ER17JN11.009_original_size.png"},"ER17JN11.008":{"large":"https://img.federalregister.gov/ER17JN11.008/ER17JN11.008_large.png","medium":"https://img.federalregister.gov/ER17JN11.008/ER17JN11.008_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.008/ER17JN11.008_original_size.png"},"ER17JN11.007":{"large":"https://img.federalregister.gov/ER17JN11.007/ER17JN11.007_large.png","medium":"https://img.federalregister.gov/ER17JN11.007/ER17JN11.007_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.007/ER17JN11.007_original_size.png"},"ER17JN11.006":{"large":"https://img.federalregister.gov/ER17JN11.006/ER17JN11.006_large.png","medium":"https://img.federalregister.gov/ER17JN11.006/ER17JN11.006_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.006/ER17JN11.006_original_size.png"},"ER17JN11.005":{"large":"https://img.federalregister.gov/ER17JN11.005/ER17JN11.005_large.png","medium":"https://img.federalregister.gov/ER17JN11.005/ER17JN11.005_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.005/ER17JN11.005_original_size.png"},"ER17JN11.004":{"large":"https://img.federalregister.gov/ER17JN11.004/ER17JN11.004_large.png","medium":"https://img.federalregister.gov/ER17JN11.004/ER17JN11.004_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.004/ER17JN11.004_original_size.png"},"ER17JN11.003":{"large":"https://img.federalregister.gov/ER17JN11.003/ER17JN11.003_large.png","medium":"https://img.federalregister.gov/ER17JN11.003/ER17JN11.003_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.003/ER17JN11.003_original_size.png"},"ER17JN11.002":{"large":"https://img.federalregister.gov/ER17JN11.002/ER17JN11.002_large.png","medium":"https://img.federalregister.gov/ER17JN11.002/ER17JN11.002_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.002/ER17JN11.002_original_size.png"},"ER17JN11.001":{"large":"https://img.federalregister.gov/ER17JN11.001/ER17JN11.001_large.png","medium":"https://img.federalregister.gov/ER17JN11.001/ER17JN11.001_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.001/ER17JN11.001_original_size.png"},"ER17JN11.012":{"large":"https://img.federalregister.gov/ER17JN11.012/ER17JN11.012_large.png","medium":"https://img.federalregister.gov/ER17JN11.012/ER17JN11.012_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.012/ER17JN11.012_original_size.png"},"ER17JN11.011":{"large":"https://img.federalregister.gov/ER17JN11.011/ER17JN11.011_large.png","medium":"https://img.federalregister.gov/ER17JN11.011/ER17JN11.011_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.011/ER17JN11.011_original_size.png"},"ER17JN11.010":{"large":"https://img.federalregister.gov/ER17JN11.010/ER17JN11.010_large.png","medium":"https://img.federalregister.gov/ER17JN11.010/ER17JN11.010_medium.png","original_size":"https://img.federalregister.gov/ER17JN11.010/ER17JN11.010_original_size.png"}},"images_metadata":{"ER17JN11.009":{"large":{"identifier":"ER17JN11.009","content_type":"image/png","size":910,"width":124,"sha":"f5b118521346e74314bdeabafb71cf64","url":"https://img.federalregister.gov/ER17JN11.009/ER17JN11.009_large.png","height":33},"medium":{"identifier":"ER17JN11.009","content_type":"image/png","size":395,"width":59,"sha":"18ff99cebaf3b326b087204d7b1d55ff","url":"https://img.federalregister.gov/ER17JN11.009/ER17JN11.009_medium.png","height":16},"original_size":{"identifier":"ER17JN11.009","content_type":"image/png","size":1534,"width":443,"sha":"86340cf137a574a739b3170b9ec2935f","url":"https://img.federalregister.gov/ER17JN11.009/ER17JN11.009_original_size.png","height":118}},"ER17JN11.008":{"large":{"identifier":"ER17JN11.008","content_type":"image/png","size":1311,"width":195,"sha":"e172a6ae37d5346bf1855e6a521e9fff","url":"https://img.federalregister.gov/ER17JN11.008/ER17JN11.008_large.png","height":32},"medium":{"identifier":"ER17JN11.008","content_type":"image/png","size":502,"width":92,"sha":"cee62c4e90bed8b27d26445f81b3eb0e","url":"https://img.federalregister.gov/ER17JN11.008/ER17JN11.008_medium.png","height":15},"original_size":{"identifier":"ER17JN11.008","content_type":"image/png","size":2052,"width":691,"sha":"5012eaf9083735383a8d59cad0b49130","url":"https://img.federalregister.gov/ER17JN11.008/ER17JN11.008_original_size.png","height":115}},"ER17JN11.007":{"large":{"identifier":"ER17JN11.007","content_type":"image/png","size":3286,"width":305,"sha":"693bf164a1d3861e49138c05e70e28c2","url":"https://img.federalregister.gov/ER17JN11.007/ER17JN11.007_large.png","height":98},"medium":{"identifier":"ER17JN11.007","content_type":"image/png","size":1151,"width":143,"sha":"1f7a99d8faa0ddfef1ac4946838bce7d","url":"https://img.federalregister.gov/ER17JN11.007/ER17JN11.007_medium.png","height":46},"original_size":{"identifier":"ER17JN11.007","content_type":"image/png","size":5038,"width":1090,"sha":"e381f17e399eef7604f5384b054d22ca","url":"https://img.federalregister.gov/ER17JN11.007/ER17JN11.007_original_size.png","height":350}},"ER17JN11.006":{"large":{"identifier":"ER17JN11.006","content_type":"image/png","size":2608,"width":216,"sha":"f07d8afb0568045db84b851892e7914b","url":"https://img.federalregister.gov/ER17JN11.006/ER17JN11.006_large.png","height":89},"medium":{"identifier":"ER17JN11.006","content_type":"image/png","size":1117,"width":102,"sha":"2ad2b9986d516e4fe2a2a531825959cc","url":"https://img.federalregister.gov/ER17JN11.006/ER17JN11.006_medium.png","height":42},"original_size":{"identifier":"ER17JN11.006","content_type":"image/png","size":4247,"width":763,"sha":"b7f930919aa1fdff9399bc661cf20c0f","url":"https://img.federalregister.gov/ER17JN11.006/ER17JN11.006_original_size.png","height":313}},"ER17JN11.005":{"large":{"identifier":"ER17JN11.005","content_type":"image/png","size":1626,"width":158,"sha":"eacdecaf8e2ac6cddeab4a8b438fd4c9","url":"https://img.federalregister.gov/ER17JN11.005/ER17JN11.005_large.png","height":58},"medium":{"identifier":"ER17JN11.005","content_type":"image/png","size":597,"width":75,"sha":"1cb3529329201a6b22d1b6fb37d29787","url":"https://img.federalregister.gov/ER17JN11.005/ER17JN11.005_medium.png","height":28},"original_size":{"identifier":"ER17JN11.005","content_type":"image/png","size":2533,"width":564,"sha":"d4a24e266355315f32f60ee0c95ec702","url":"https://img.federalregister.gov/ER17JN11.005/ER17JN11.005_original_size.png","height":207}},"ER17JN11.004":{"large":{"identifier":"ER17JN11.004","content_type":"image/png","size":15724,"width":823,"sha":"2cb014a68b92fc9f90693a74aae979d8","url":"https://img.federalregister.gov/ER17JN11.004/ER17JN11.004_large.png","height":157},"medium":{"identifier":"ER17JN11.004","content_type":"image/png","size":5843,"width":432,"sha":"4eeff1d05345f96ca55ddd6b9059533f","url":"https://img.federalregister.gov/ER17JN11.004/ER17JN11.004_medium.png","height":82},"original_size":{"identifier":"ER17JN11.004","content_type":"image/png","size":28581,"width":3261,"sha":"59d07e958ec9b3abd0e1359ef18bc6e3","url":"https://img.federalregister.gov/ER17JN11.004/ER17JN11.004_original_size.png","height":622}},"ER17JN11.003":{"large":{"identifier":"ER17JN11.003","content_type":"image/png","size":1709,"width":171,"sha":"8ee7929528b6e603585655282ad93519","url":"https://img.federalregister.gov/ER17JN11.003/ER17JN11.003_large.png","height":70},"medium":{"identifier":"ER17JN11.003","content_type":"image/png","size":733,"width":81,"sha":"360e3b835b18313ded096b2deb2ecea1","url":"https://img.federalregister.gov/ER17JN11.003/ER17JN11.003_medium.png","height":33},"original_size":{"identifier":"ER17JN11.003","content_type":"image/png","size":2883,"width":610,"sha":"f314195496b98a8ffe530f5efef7ead4","url":"https://img.federalregister.gov/ER17JN11.003/ER17JN11.003_original_size.png","height":249}},"ER17JN11.002":{"large":{"identifier":"ER17JN11.002","content_type":"image/png","size":1846,"width":263,"sha":"a2850119d827a2c1f9ae432b223703fb","url":"https://img.federalregister.gov/ER17JN11.002/ER17JN11.002_large.png","height":41},"medium":{"identifier":"ER17JN11.002","content_type":"image/png","size":779,"width":124,"sha":"c93ea756a2f918a838c8ada281461c59","url":"https://img.federalregister.gov/ER17JN11.002/ER17JN11.002_medium.png","height":20},"original_size":{"identifier":"ER17JN11.002","content_type":"image/png","size":15512,"width":934,"sha":"1f014ba56fd0251561f0c36fc8c80b12","url":"https://img.federalregister.gov/ER17JN11.002/ER17JN11.002_original_size.png","height":147}},"ER17JN11.001":{"large":{"identifier":"ER17JN11.001","content_type":"image/png","size":3755,"width":380,"sha":"7b6580f28d2497cdef392800931bde71","url":"https://img.federalregister.gov/ER17JN11.001/ER17JN11.001_large.png","height":98},"medium":{"identifier":"ER17JN11.001","content_type":"image/png","size":1546,"width":178,"sha":"b1dd8aa82c8ecc12d8105acc9ff2d3a8","url":"https://img.federalregister.gov/ER17JN11.001/ER17JN11.001_medium.png","height":46},"original_size":{"identifier":"ER17JN11.001","content_type":"image/png","size":6342,"width":1361,"sha":"2896f769489d4a0f15e47629369f751e","url":"https://img.federalregister.gov/ER17JN11.001/ER17JN11.001_original_size.png","height":351}},"ER17JN11.012":{"large":{"identifier":"ER17JN11.012","content_type":"image/png","size":1147,"width":170,"sha":"ce81c85f2b948adc9afb5af67113c72c","url":"https://img.federalregister.gov/ER17JN11.012/ER17JN11.012_large.png","height":33},"medium":{"identifier":"ER17JN11.012","content_type":"image/png","size":485,"width":81,"sha":"44c86097097859bb01cb5ef998150805","url":"https://img.federalregister.gov/ER17JN11.012/ER17JN11.012_medium.png","height":16},"original_size":{"identifier":"ER17JN11.012","content_type":"image/png","size":1783,"width":609,"sha":"e51eea2ceae83ccccdec5b3132e1e8b2","url":"https://img.federalregister.gov/ER17JN11.012/ER17JN11.012_original_size.png","height":118}},"ER17JN11.011":{"large":{"identifier":"ER17JN11.011","content_type":"image/png","size":617,"width":66,"sha":"cb7e5ae9d6254a1e93264f27cf2a4bee","url":"https://img.federalregister.gov/ER17JN11.011/ER17JN11.011_large.png","height":32},"medium":{"identifier":"ER17JN11.011","content_type":"image/png","size":251,"width":31,"sha":"de8637bc44b815e6a559500da39ab22d","url":"https://img.federalregister.gov/ER17JN11.011/ER17JN11.011_medium.png","height":15},"original_size":{"identifier":"ER17JN11.011","content_type":"image/png","size":866,"width":235,"sha":"1cd258099d24ba7a87fe983ffb5116b4","url":"https://img.federalregister.gov/ER17JN11.011/ER17JN11.011_original_size.png","height":115}},"ER17JN11.010":{"large":{"identifier":"ER17JN11.010","content_type":"image/png","size":522,"width":63,"sha":"d8751bfe3d4f792960eb2a8daa77f95f","url":"https://img.federalregister.gov/ER17JN11.010/ER17JN11.010_large.png","height":32},"medium":{"identifier":"ER17JN11.010","content_type":"image/png","size":247,"width":30,"sha":"4219129b9459e55771e394e862a8aef1","url":"https://img.federalregister.gov/ER17JN11.010/ER17JN11.010_medium.png","height":15},"original_size":{"identifier":"ER17JN11.010","content_type":"image/png","size":771,"width":225,"sha":"f3b9935510bc47ce794593e04a842f31","url":"https://img.federalregister.gov/ER17JN11.010/ER17JN11.010_original_size.png","height":115}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-14766?publication_date=2011-06-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-06-17/2011-14766/mods.xml","not_received_for_publication":null,"page_length":46,"page_views":{"count":10860,"last_updated":"2026-04-23 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/2011-14766.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/2011/06/17/2011-14766.txt","regulation_id_number_info":{"0910-AF43":{"issue":"201910","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","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=0910-AF43&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AF43"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-07-07T08:07:55Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":35620,"subtype":null,"title":"Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use","toc_doc":"Sunscreen Drug Products for Over-the-;Counter Human Use","toc_subject":"Labeling and Effectiveness Testing:","topics":["Administrative practice and procedure","Drugs","Incorporation by reference","Labeling","Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":76}