Label: COPPERTONE PROTECT AND TAN SPF 30- avobenzone 3%, homosalate 14%, octisalate 4.5%, octocrylene 9% lotion
- NDC Code(s): 66800-0082-1
- Packager: Beiersdorf Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Use
- Warnings
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Directions
■ shake well before use
■ apply liberally 15 minutes before sun exposure
■ reapply:
■ after 80 minutes of swimming or sweating
■ immediately after towel drying
■ at least every 2 hours
■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
■ limit time in the sun, especially from 10 a.m. – 2 p.m.
■ wear long-sleeve shirts, pants, hats, and sunglasses
■ children under 6 months: Ask a doctor
- Other information
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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, pentylene glycol, tocopherol, fragrance, caramel
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INGREDIENTS AND APPEARANCE
COPPERTONE PROTECT AND TAN SPF 30
avobenzone 3%, homosalate 14%, octisalate 4.5%, octocrylene 9% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-0082 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 14 g in 100 g Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) CARAMEL (UNII: T9D99G2B1R) L-ERYTHRULOSE (UNII: WKK1W5B83O) ALLYL METHACRYLATE (UNII: G2IG50653Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) PENTYLENE GLYCOL (UNII: 50C1307PZG) DOCOSANOL (UNII: 9G1OE216XY) DIHYDROXYACETONE (UNII: O10DDW6JOO) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) 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:66800-0082-1 148 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2021 Labeler - Beiersdorf Inc (001177906)