Label: COPPERTONE SPORT SUNSCREEN SPF 100- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10%, oxybenzone 6% lotion
- NDC Code(s): 66800-2465-3
- 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 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Use
- Warnings
-
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
-
Inactive ingredients
water, butyloctyl salicylate, styrene/acrylates copolymer, butylene glycol, benzyl alcohol, bis-stearyl ethylenediamine/neopentyl glycol/stearyl hydrogenated dimer dilinoleate copolymer, 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
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COPPERTONE SPORT SUNSCREEN SPF 100
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10%, oxybenzone 6% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-2465 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) TROLAMINE (UNII: 9O3K93S3TK) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BENZYL ALCOHOL (UNII: LKG8494WBH) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) OLETH-3 (UNII: BQZ26235UC) FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) WATER (UNII: 059QF0KO0R) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) 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:66800-2465-3 88 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)
