Label: COPPERTONE OIL FREE SUNSCREEN SPF 30- avobenzone 3%, homosalate 8%, octisalate 4.5%, octocrylene 6% lotion
- NDC Code(s): 66800-3900-3
- 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 7, 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
- 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, glycerin, polyester-27, silica, styrene/acrylates copolymer, phenoxyethanol, isododecane, arachidyl alcohol, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate
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INGREDIENTS AND APPEARANCE
COPPERTONE OIL FREE SUNSCREEN SPF 30
avobenzone 3%, homosalate 8%, octisalate 4.5%, octocrylene 6% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-3900 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DOCOSANOL (UNII: 9G1OE216XY) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) PHENOXYETHANOL (UNII: HIE492ZZ3T) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) POLYESTER-7 (UNII: 0841698D2F) 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:66800-3900-3 88 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2022 Labeler - Beiersdorf Inc (001177906)
