Label: COPPERTONE PROTECT AND TAN SUNSCREEN SPF 45- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion
- NDC Code(s): 66800-0079-1
- Packager: Beiersdort Inc
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 17, 2023
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Inactive ingredients
water, butyloctyl salicylate, neopentyl glycol diheptanoate, butylene glycol, styrene/acrylates copolymer, arachidyl alcohol, behenyl alcohol, dihydroxyacetone, acrylates/C12-22 alkyl methacrylate copolymer, 1,2-hexanediol, sodium stearoyl glutamate, arachidyl glucoside, erythrulose, hydroxyacetophenone, tocopherol, fragrance, pentylene glycol, caramel
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INGREDIENTS AND APPEARANCE
COPPERTONE PROTECT AND TAN SUNSCREEN SPF 45
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-0079 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) ALLYL METHACRYLATE (UNII: G2IG50653Z) WATER (UNII: 059QF0KO0R) L-ERYTHRULOSE (UNII: WKK1W5B83O) DOCOSANOL (UNII: 9G1OE216XY) DIHYDROXYACETONE (UNII: O10DDW6JOO) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) PENTYLENE GLYCOL (UNII: 50C1307PZG) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color white (White to Off-White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-0079-1 148 g in 1 TUBE; Type 0: Not a Combination Product 11/03/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/03/2021 Labeler - Beiersdort Inc (001177906)