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

  • NDC Code(s): 66800-8159-2, 66800-8159-5
  • 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 April 17, 2023

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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 on damaged or broken skin
    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2023
    Labeler - Beiersdorf Inc (001177906)
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