Label: COPPERTONE TANNING SUNSCREEN SPF 15- avobenzone 2%, homosalate 5%, octisalate 4.5%, octocrylene 3% lotion

  • 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 17, 2023

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  • Drug Facts

  • Active ingredients

    Avobenzone 2%, Homosalate 5%, Octisalate 4.5%, Octocrylene 3%

  • 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 80 minutes of swimming or sweating

    ■ immediately after towel drying

    ■ at least every 2 hours

    ■ 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

  • Inactive ingredients

    water, aluminum starch octenylsuccinate, glycerin, silica, phenoxyethanol, isododecane, ethylhexylglycerin, polyester-27, styrene/acrylates copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl alcohol, neopentyl glycol diheptanoate, glyceryl stearate, PEG-100 stearate, tocopherol, beeswax, fragrance, behenyl alcohol, arachidyl glucoside, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

  • Questions?

    1-866-288-3330

  • PRINCIPAL DISPLAY PANEL

    Coppertone ® Sunscreen Lotion

    Tanning

    Lightweight & Moisturizing 15

    No Dyes, PABA, Oxybenzone

    Water Resistant (80 Minutes)

    8 FL OZ (237 mL)

    Tanning Spray SPF 15

  • INGREDIENTS AND APPEARANCE
    COPPERTONE TANNING SUNSCREEN SPF 15 
    avobenzone 2%, homosalate 5%, octisalate 4.5%, octocrylene 3% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-4087
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISODODECANE (UNII: A8289P68Y2)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POLYESTER-7 (UNII: 0841698D2F)  
    Product Characteristics
    Colorwhite (White to Off-White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-4087-1237 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/20/2021
    Labeler - Beiersdorf Inc (001177906)
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