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Sunscreen drug products for over-the-counter human use; final monograph. Food and Drug Administration, HHS. Final rule.
Fed Regist. 1999 May 21; 64(98):27666-93.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and new data and information on sunscreen drug products that have come to the agency's attention. FDA is also issuing final rules regarding the labeling of certain cosmetic products to inform consumers that these products do not provide protection from the sun.

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MeSH

Consumer Product SafetyDrug LabelingErythemaHumansSpectrophotometrySunscreening AgentsUltraviolet RaysUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10558542

Citation

"Sunscreen Drug Products for Over-the-counter Human Use; Final Monograph. Food and Drug Administration, HHS. Final Rule." Federal Register, vol. 64, no. 98, 1999, pp. 27666-93.
Sunscreen drug products for over-the-counter human use; final monograph. Food and Drug Administration, HHS. Final rule. Fed Regist. 1999;64(98):27666-93.
(1999). Sunscreen drug products for over-the-counter human use; final monograph. Food and Drug Administration, HHS. Final rule. Federal Register, 64(98), 27666-93.
Sunscreen Drug Products for Over-the-counter Human Use; Final Monograph. Food and Drug Administration, HHS. Final Rule. Fed Regist. 1999 May 21;64(98):27666-93. PubMed PMID: 10558542.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sunscreen drug products for over-the-counter human use; final monograph. Food and Drug Administration, HHS. Final rule. PY - 1999/11/11/pubmed PY - 1999/11/11/medline PY - 1999/11/11/entrez SP - 27666 EP - 93 JF - Federal register JO - Fed Regist VL - 64 IS - 98 N2 - The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and new data and information on sunscreen drug products that have come to the agency's attention. FDA is also issuing final rules regarding the labeling of certain cosmetic products to inform consumers that these products do not provide protection from the sun. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/10558542/Sunscreen_drug_products_for_over_the_counter_human_use L2 - https://www.govinfo.gov/content/pkg/FR-1999-05-21/pdf/99-12853.pdf DB - PRIME DP - Unbound Medicine ER -