federal_register: 2011-14769
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-14769 | Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use | Proposed Rule | The Food and Drug Administration (FDA) is proposing to limit the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug products to "50+." We are issuing this proposed rule after reviewing data and information we received on the safety and effectiveness of OTC sunscreen drug products after publication of our 2007 proposed rule. The record does not currently contain sufficient data to indicate that there is additional clinical benefit above SPF 50. This proposal is part of FDA's ongoing review of these products to ensure their safety and effectiveness. | 2011-06-17 | 2011 | 6 | https://www.federalregister.gov/documents/2011/06/17/2011-14769/revised-effectiveness-determination-sunscreen-drug-products-for-over-the-counter-human-use | https://www.govinfo.gov/content/pkg/FR-2011-06-17/pdf/2011-14769.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to limit the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug products to "50+." We are issuing this proposed rule after reviewing data and information we received on the safety and... |