{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of letters containing FDA's initial determinations and feedback on safety and effectiveness data submitted to demonstrate that certain active ingredients are generally recognized as safe and effective (GRASE) and not misbranded for use in over-the-counter (OTC) sunscreen drug products (sunscreen feedback letters). We are taking this action under the Sunscreen Innovation Act (SIA).","action":"Notice; request for comments.","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/2015/01/07/2015-00002.html","cfr_references":[],"citation":"80 FR 892","comment_url":null,"comments_close_on":"2015-02-23","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by February 23, 2015. Sponsors may submit written requests for a meeting with FDA to discuss these proposed sunscreen orders by February 6, 2015.","disposition_notes":null,"docket_ids":["Docket Nos. FDA-2005-N-0453, FDA-2003-N-0196, and FDA-2006-O-0314"],"dockets":[{"supporting_documents":[{"title":"Reference 30 - International Conference on Harmonization (ICH) Toxicokinetics:  The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0090"},{"title":"Reference 29 - International Conference on Harmonization (ICH)  Harmonized Tripartite Guideline for Industry, Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2), 2005 re Over-the-Counter Sunscreen Drug Product","document_id":"FDA-2003-N-0196-0089"},{"title":"Reference 28 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals SIC(R2) (Revision 1), September 2008 re Over-the-Counter Sunscreen Drug Products—Regulatory Status","document_id":"FDA-2003-N-0196-0088"},{"title":"Reference 27 - Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0087"},{"title":"Reference 26 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0086"},{"title":"Reference 25 - Schlumpf et al, Endocrine Activity and Developmental Toxicity of Cosmetic UV Filters-An Update re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0085"},{"title":"Reference 24 - Schlumpf et al, Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0084"},{"title":"Reference 23 - Schlumpf et al, In Vitro and In Vivo Estrogenicity of UV Screens re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0083"},{"title":"Reference 22 - Maerkel et al, Sex- and Region-Specific Alterations of Progesterone Receptor mRNA Levels and Estrogen Sensitivity in Rat Brain Following Developmental Exposure to the Estrogenic UV Filter 4-Methylbenzylidene Camphor re Over-the-Counter Suns","document_id":"FDA-2003-N-0196-0082"},{"title":"Reference 21 - Maerkel et al, Sexually Dimorphic Gene Regulation in Brain as a Target for Endocrine Disrupters:  Developmental Exposure of Rats to 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0081"}],"agency_name":null,"documents":[{"comment_count":5,"comment_start_date":"2015-01-07","updated_at":"2023-02-28T17:10:48.645-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2003-N-0196-0057","allow_late_comments":null,"id":"FDA-2003-N-0196-0057","comment_end_date":"2015-02-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":62,"id":"FDA-2003-N-0196","title":"Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients"},{"supporting_documents":[{"title":"Bemotrizinol Dermal Carcinogenicity Summary re Supplement from Ciba Specialty Chemicals","document_id":"FDA-2005-N-0453-0033"},{"title":"Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 12 of 12 re Supplement from Ciba Specialty Chemicals Corporation","document_id":"FDA-2005-N-0453-0032"},{"title":"Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 11 of 12 re Supplement from Ciba Specialty Chemicals Corporation","document_id":"FDA-2005-N-0453-0031"},{"title":"Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 10 of 12 re Supplement from Ciba Specialty Chemicals Corporation","document_id":"FDA-2005-N-0453-0030"},{"title":"Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 9 of 12 re Supplement from Ciba Specialty Chemicals Corporation","document_id":"FDA-2005-N-0453-0029"},{"title":"Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 8 of 12 re Supplement from Ciba Specialty Chemicals Corporation","document_id":"FDA-2005-N-0453-0028"},{"title":"Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 7 of 12 re Supplement from Ciba Specialty Chemicals Corporation","document_id":"FDA-2005-N-0453-0027"},{"title":"Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 6 of 12 re Supplement from Ciba Specialty Chemicals Corporation","document_id":"FDA-2005-N-0453-0026"},{"title":"Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 5 of 12 re Supplement from Ciba Specialty Chemicals Corporation","document_id":"FDA-2005-N-0453-0025"},{"title":"Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 4 of 12 re Supplement from Ciba Specialty Chemicals Corporation","document_id":"FDA-2005-N-0453-0024"}],"agency_name":null,"documents":[{"comment_count":4,"comment_start_date":"2015-01-07","updated_at":"2023-02-28T17:10:49.044-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2005-N-0453-0036","allow_late_comments":null,"id":"FDA-2005-N-0453-0036","comment_end_date":"2015-02-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":25,"id":"FDA-2005-N-0453","title":"Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients"},{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2015-01-07","updated_at":"2023-02-28T17:10:49.490-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2006-O-0314-0005","allow_late_comments":null,"id":"FDA-2006-O-0314-0005","comment_end_date":"2015-02-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2006-O-0314","title":"Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredient"}],"document_number":"2015-00002","effective_on":null,"end_page":893,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/01/07/2015-00002.xml","html_url":"https://www.federalregister.gov/documents/2015/01/07/2015-00002/sunscreen-feedback-letters-notice-of-availability-under-the-sunscreen-innovation-act","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-00002?publication_date=2015-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-01-07/2015-00002/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2542,"last_updated":"2026-08-25 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-01-07/pdf/2015-00002.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-00002.pdf?1420552093","publication_date":"2015-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/01/07/2015-00002.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 30 - International Conference on Harmonization (ICH) Toxicokinetics:  The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0090"},{"title":"Reference 29 - International Conference on Harmonization (ICH)  Harmonized Tripartite Guideline for Industry, Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2), 2005 re Over-the-Counter Sunscreen Drug Product","document_id":"FDA-2003-N-0196-0089"},{"title":"Reference 28 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals SIC(R2) (Revision 1), September 2008 re Over-the-Counter Sunscreen Drug Products—Regulatory Status","document_id":"FDA-2003-N-0196-0088"},{"title":"Reference 27 - Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0087"},{"title":"Reference 26 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996 re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0086"},{"title":"Reference 25 - Schlumpf et al, Endocrine Activity and Developmental Toxicity of Cosmetic UV Filters-An Update re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0085"},{"title":"Reference 24 - Schlumpf et al, Estrogenic Activity and Estrogen Receptor Beta Binding of the UV Filter 3-Benzylidene Camphor. Comparison With 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0084"},{"title":"Reference 23 - Schlumpf et al, In Vitro and In Vivo Estrogenicity of UV Screens re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0083"},{"title":"Reference 22 - Maerkel et al, Sex- and Region-Specific Alterations of Progesterone Receptor mRNA Levels and Estrogen Sensitivity in Rat Brain Following Developmental Exposure to the Estrogenic UV Filter 4-Methylbenzylidene Camphor re Over-the-Counter Suns","document_id":"FDA-2003-N-0196-0082"},{"title":"Reference 21 - Maerkel et al, Sexually Dimorphic Gene Regulation in Brain as a Target for Endocrine Disrupters:  Developmental Exposure of Rats to 4-Methylbenzylidene Camphor re Over-the-Counter Sunscreen Drug Products—Regulatory Status of Enzacamene","document_id":"FDA-2003-N-0196-0081"}],"comments_count":5,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2003-N-0196","supporting_documents_count":62,"docket_id":"FDA-2003-N-0196","document_id":"FDA-2003-N-0196-0057","regulation_id_number":null,"title":"Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients","checked_regulationsdotgov_at":"2023-02-28T22:10:47Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":892,"subtype":null,"title":"Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen Innovation Act","toc_doc":"Sunscreen Feedback Letters","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}