Label: COPPERTONE SPORT SUNSCREEN SPL 15- avobenzone 2%, homosalate 5%, octisalate 4.5%, octocrylene 3% lotion
- NDC Code(s): 66800-3091-7
- 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 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Use
- 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, aluminum starch octenylsuccinate, glycerin, silica, phenoxyethanol, isododecane, ethylhexylglycerin, polyester-27, styrene/acrylates copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl alcohol, neopentyl glycol diheptanoate, tocopherol (vitamin E), glyceryl stearate, PEG-100 stearate, beeswax, behenyl alcohol, arachidyl glucoside, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance
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INGREDIENTS AND APPEARANCE
COPPERTONE SPORT SUNSCREEN SPL 15
avobenzone 2%, homosalate 5%, octisalate 4.5%, octocrylene 3% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-3091 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) TOCOPHEROL (UNII: R0ZB2556P8) BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) OLETH-3 (UNII: BQZ26235UC) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) TROLAMINE (UNII: 9O3K93S3TK) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) CHLORPHENESIN (UNII: I670DAL4SZ) 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:66800-3091-7 207 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2021 Labeler - Beiersdorf Inc (001177906)
