Label: COPPERTONE PROTECT AND TAN SUNSCREEN SPF 45- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% 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 3%, Homosalate 15%, 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.

  • Other information

    ■ protect this product from excessive heat and direct sun

    ■ may stain or damage some fabrics or surfaces

  • Inactive ingredients

    water, butyloctyl salicylate, neopentyl glycol diheptanoate, butylene glycol, styrene/acrylates copolymer, arachidyl alcohol, behenyl alcohol, dihydroxyacetone, acrylates/C12-22 alkyl methacrylate copolymer, 1,2-hexanediol, sodium stearoyl glutamate, arachidyl glucoside, erythrulose, hydroxyacetophenone, tocopherol, fragrance, pentylene glycol, caramel

  • Questions?

    1-866-288-3330

  • PRINCIPAL DISPLAY PANEL

    Coppertone® Sunscreen + Self Tanner

    Glow

    Protect & Tan 45

    UVA/UVB Protection + Gradual Tanner

    Free of Oxybenzone, Octinoxate, Dyes & PABA

    Water Resistant (80 Minutes)

    Broad Spectrum SPF 45

    5 FL OZ (148 mL)

    Glow PandT SPF45

  • INGREDIENTS AND APPEARANCE
    COPPERTONE PROTECT AND TAN SUNSCREEN SPF 45 
    avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-0079
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    ALLYL METHACRYLATE (UNII: G2IG50653Z)  
    WATER (UNII: 059QF0KO0R)  
    L-ERYTHRULOSE (UNII: WKK1W5B83O)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    DIHYDROXYACETONE (UNII: O10DDW6JOO)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    Colorwhite (White to Off-White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-0079-1148 g in 1 TUBE; Type 0: Not a Combination Product11/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/03/2021
    Labeler - Beiersdort Inc (001177906)
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