Label: COPPERTONE COMPLETE SUNSCREEN SPF 30- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 8% lotion
- NDC Code(s): 66800-0026-7
- 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 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, diethylhexyl carbonate, butyloctyl salicylate, diisopropyl adipate, glycereth-26, butylene glycol, dimethicone, polyamide-8, isododecane, styrene/acrylates copolymer, 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 30
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 8% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-0026 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 8 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) GLYCERETH-26 (UNII: NNE56F2N14) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) ISODODECANE (UNII: A8289P68Y2) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) TOCOPHEROL (UNII: R0ZB2556P8) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB) XANTHAN GUM (UNII: TTV12P4NEE) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIMETHICONE (UNII: 92RU3N3Y1O) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) 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:66800-0026-7 207 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)