federal_register: 98-28274
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 98-28274 | Sunscreen Drug Products for Over-the-Counter Human Use; Amendment to the Tentative Final Monograph; Enforcement Policy | Proposed Rule | 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. | 1998-10-22 | 1998 | 10 | 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 | https://www.govinfo.gov/content/pkg/FR-1998-10-22/pdf/98-28274.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | 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... |