Label: COPPERTONE OIL FREE SPF 50 SUNSCREEN- avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotion
- NDC Code(s): 66800-4094-3
- 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
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- Official Label (Printer Friendly)
- 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, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-27, silica, phenoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate
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INGREDIENTS AND APPEARANCE
COPPERTONE OIL FREE SPF 50 SUNSCREEN
avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4094 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) POLYESTER-7 (UNII: 0841698D2F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DOCOSANOL (UNII: 9G1OE216XY) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISODODECANE (UNII: A8289P68Y2) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-4094-3 88 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2022 Labeler - Beiersdorf Inc (001177906)
