Label: COPPERTONE OIL FREE AND SHINE CONTROL FACE SUNSCREEN SPF 45- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion
- NDC Code(s): 66800-8164-2
- 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 3, 2023
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- Drug Facts
- Active ingredients
- Purpose
- Use
- Warnings
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Directions
■ apply liberally 15 minutes before sun exposure
■ reapply:
■ after 40 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, alcohol denat., butyloctyl salicylate, silica,bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, tapioca starch, behenyl alcohol, butylene glycol dicaprylate/dicaprate, C12-15 alkyl benzoate, cetearyl alcohol, copernicia cerifera (carnauba) wax, dibutyl adipate, tocopherol (Vitamin E), silica dimethyl silylate, sodium stearoyl glutamate, glyceryl behenate, polyglyceryl-6 octastearate, diethylhexyl syringylidenemalonate, phenoxyethanol, xanthan gum, ethylhexylglycerin, hydroxyacetophenone, disodium EDTA, glycerin, cetyl alcohol, sodium ascorbyl phosphate
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INGREDIENTS AND APPEARANCE
COPPERTONE OIL FREE AND SHINE CONTROL FACE SUNSCREEN SPF 45
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-8164 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 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 CARNAUBA WAX (UNII: R12CBM0EIZ) DIBUTYL ADIPATE (UNII: F4K100DXP3) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) POLYGLYCERYL-6 ISOSTEARATE (UNII: 5VKGO1O03G) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) ALCOHOL (UNII: 3K9958V90M) ETHYLHEXYLGLYCERYL BEHENATE (UNII: JRY34LRD7B) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) STARCH, TAPIOCA (UNII: 24SC3U704I) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TOCOPHEROL (UNII: R0ZB2556P8) DOCOSANOL (UNII: 9G1OE216XY) 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:66800-8164-2 74 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2023 Labeler - Beiersdorf Inc (001177906)