Label: COPPERTONE SUNSCREEN SPF 50- avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotion
- NDC Code(s): 66800-4107-3, 66800-4107-7, 66800-4107-8, 66800-4107-9
- Packager: Beiersdorf Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 29, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Use
- Warnings
- DO NOT USE
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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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, fragrance, disodium EDTA, sodium ascorbyl phosphate
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INGREDIENTS AND APPEARANCE
COPPERTONE SUNSCREEN SPF 50
avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) PEG-20 STEARATE (UNII: NBX892EA57) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) GLYCERIN (UNII: PDC6A3C0OX) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) WATER (UNII: 059QF0KO0R) FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0) POLYESTER-7 (UNII: 0841698D2F) ISODODECANE (UNII: A8289P68Y2) 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:66800-4107-3 89 g in 1 TUBE; Type 0: Not a Combination Product 11/02/2020 2 NDC:66800-4107-7 207 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2020 3 NDC:66800-4107-8 259 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2020 4 NDC:66800-4107-9 269 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/02/2020 Labeler - Beiersdorf Inc (001177906)