Label: COPPERTONE SPORT SUNSCREEN SPF 70- avobenzone 3%, homosalate 13%, octisalate 5%, octocrylene 10%, oxybenzone 6% lotion
- NDC Code(s): 66800-2461-7
- 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 February 15, 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, butyloctyl salicylate, butylene glycol, styrene/acrylates copolymer, bis-stearyl ethylenediamine/neopentyl glycol/stearyl hydrogenated dimer dilinoleate copolymer, benzyl alcohol, tocopherol (vitamin E), diethylhexyl syringylidenemalonate, retinyl palmitate (vitamin A palmitate), sodium ascorbyl phosphate, triethanolamine, chlorphenesin, acrylates/C10-30 alkyl acrylate crosspolymer, oleth-3, fragrance, disodium EDTA
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INGREDIENTS AND APPEARANCE
COPPERTONE SPORT SUNSCREEN SPF 70
avobenzone 3%, homosalate 13%, octisalate 5%, octocrylene 10%, oxybenzone 6% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-2461 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 13 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) TOCOPHEROL (UNII: R0ZB2556P8) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) WATER (UNII: 059QF0KO0R) OLETH-3 (UNII: BQZ26235UC) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) BENZYL ALCOHOL (UNII: LKG8494WBH) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) CHLORPHENESIN (UNII: I670DAL4SZ) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) TROLAMINE (UNII: 9O3K93S3TK) FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 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:66800-2461-7 207 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2000 Labeler - Beiersdorf Inc (001177906)
