Label: COPPERTONE COMPLETE SUNSCREEN SPF 45- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion

  • NDC Code(s): 66800-8159-1, 66800-8159-2, 66800-8159-5
  • Packager: Beiersdorf Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 15, 2024

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  • Drug Facts

  • Active ingredients

    Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

  • Purpose

    Sunscreen

  • Use

    ■ helps prevent sunburn

  • Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    ■ protect this product from excessive heat and direct sun

    ■ may stain or damage some fabrics or surfaces

  • Questions?

    1-866-288-3330

  • 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), sodium ascorbyl phosphate, silica dimethyl silylate, sodium stearoyl glutamate, glyceryl behenate, polyglyceryl-6 octastearate, diethylhexyl syringylidenemalonate, phenoxyethanol, xanthan gum, ethylhexylglycerin, hydroxyacetophenone, disodium EDTA, glycerin, sodium hyaluronate, cetyl alcohol

  • PRINCIPAL DISPLAY PANEL

    Coppertone® Sunscreen Lotion

    Complete Face 45

    Proven UVA/UVB Protection

    +Hydrates

    +Weightless & Oil Free

    Free of Oxybenzone, Octinoxate, Dyes & PABA

    Water Resistant (40 Minutes)

    Broad Spectrum SPF 45

    Complete Face 45

  • INGREDIENTS AND APPEARANCE
    COPPERTONE COMPLETE SUNSCREEN SPF 45 
    avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 10% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-8159
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DIBUTYL ADIPATE (UNII: F4K100DXP3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ETHYLHEXYLGLYCERYL BEHENATE (UNII: JRY34LRD7B)  
    Product Characteristics
    Colorwhite ((white to off-white)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-8159-274 g in 1 TUBE; Type 0: Not a Combination Product01/01/2023
    2NDC:66800-8159-514 g in 1 POUCH; Type 0: Not a Combination Product02/10/2023
    3NDC:66800-8159-144 g in 1 TUBE; Type 0: Not a Combination Product01/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2023
    Labeler - Beiersdorf Inc (001177906)
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