Label: COPPERTONE COMPLETE SUNSCREEN SPF 50- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion
- NDC Code(s): 66800-0030-7
- Packager: Beiersdorf 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 March 5, 2023
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- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
■ 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, SD alcohol 40-B, butyloctyl salicylate, diethylhexyl carbonate, glycereth-26, styrene/acrylates copolymer, butylene glycol, diisopropyl adipate, dimethicone, polyamide-8, isododecane, 1,2-hexanediol, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer, glycerin, hydroxyacetophenone, tocopherol, ethylhexyl methoxycrylene, arachidyl alcohol, fragrance, xanthan gum, behenyl alcohol, arachidyl glucoside, disodium EDTA, sodium ascorbyl phosphate
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INGREDIENTS AND APPEARANCE
COPPERTONE COMPLETE SUNSCREEN SPF 50
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-0030 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DOCOSANOL (UNII: 9G1OE216XY) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERETH-26 (UNII: NNE56F2N14) ALCOHOL (UNII: 3K9958V90M) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB) WATER (UNII: 059QF0KO0R) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) XANTHAN GUM (UNII: TTV12P4NEE) DIMETHICONE (UNII: 92RU3N3Y1O) 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:66800-0030-7 207 g in 1 TUBE; 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)