Dps-admin.fda.gov

U.S. FOOD AND DRUG ADMINISTRATION PROPOSED ORDER …

WEB2 The 2019 Proposed Rule proposed to amend the sunscreen monograph regulation then codified in 21 CFR part 352 (which was issued in 1999 but stayed indefinitely prior to …

Actived: 1 days ago

URL: https://dps-admin.fda.gov/omuf/omuf/sites/omuf/files/primary-documents/2022-09/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf

U.S. Food and Drug Administration Sunscreen Drug Products …

WEB(2) For sunscreen products that are broad spectrum with SPF values of at least 2 but less than 15 according to the SPF test in §M020.80 or that do not pass the broad spectrum test

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U.S. Food and Drug Administration Final Administrative Order …

WEBAn over-the-counter (OTC) first aid antiseptic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it …

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U.S. Food and Drug Administration Antacid Products for Over …

WEB(b) Indications. The labeling of the product states, under the heading “Uses,” any of the phrases listed in § M001.30(b), as appropriate. Other truthful and nonmisleading …

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U.S. Food and Drug Administration Counter Human Use …

WEBAn over-the-counter (OTC) cold, cough, allergy, bronchodilator, or antiasthmatic drug product in a form suitable for oral, inhalant, or topical administration is generally …

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U.S. Food and Drug Administration Sunscreen Drug Products …

WEBFinal Administrative Order OTC000006 Page 3 . dosage forms that cannot currently be legally marketed without an approved application (or a final order issued under 505G) …

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dps-admin.fda.gov

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