Label: COPPERTONE GLOW HYDRAGEL SPF 50- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • Drug Facts

    Drug Facts

  • Active Ingredients

    Active Ingredients

    Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

  • Purpose

    Purpose

    Sunscreen

  • Uses

    Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    Warnings

    • For external use only
    • Flammable. Keep away from fire or flame.
  • 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

    Directions

    ■ shake well before each use

    ■ apply liberally 15 minutes before sun exposure

    ■ reapply:

    ■ after 80 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

    Other information

    ■ protect this product from excessive heat and direct sun

    ■ may stain or damage some fabrics or surfaces

  • Inactive Ingredients

    Inactive ingredients SD alcohol 40-B (57.4% v/v), butyloctyl salicylate, dicaprylyl ether, ethylhexyl isononanoate, PVP, dimethicone/vinyl dimethicone crosspolymer, polyester-27, silica dimethicone silylate, acrylates/C12-22 alkyl methacrylate copolymer, calcium starch octenylsuccinate, fragrance, silica, synthetic fluorphlogopite, iron oxides

  • Questions

    Questions? 1-866-288-3330

  • Principal Display Panel

    Glow HydragelCoppertone Sunscreen Gel

    Glow Hydragel

    SPF 50

    Shimmery, Cool & Hydrating

    Broad Spectrum SPF 50

    Water Resistant (80 Minutes)

    Free of oxybenzone, octinoxate, PABA & parabens

    4.5 FL OZ (133 mL)

  • INGREDIENTS AND APPEARANCE
    COPPERTONE GLOW HYDRAGEL SPF 50 
    avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-4473
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALUMINUM MAGNESIUM HYDROXIDE CARBONATE (UNII: RFJ7QXF345)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    POLYESTER-7 (UNII: 0841698D2F)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALCOHOL (UNII: 3K9958V90M)  
    OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    Product Characteristics
    Colorwhite (white to clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-4473-4133 mL in 1 TUBE; Type 0: Not a Combination Product11/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/02/2020
    Labeler - Beiersdort Inc (001177906)
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