Label: COPPERTONE SUNSCREEN SPF 50- avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotion

  • NDC Code(s): 66800-4107-3, 66800-4107-7, 66800-4107-8, 66800-4107-9
  • Packager: Beiersdorf Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 29, 2024

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  • Drug Facts

  • Active ingredients

    Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 8%

  • Purpose

    Sunscreen

  • Use

    ■ helps prevent sunburn

  • Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • WHEN USING

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

  • 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 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

    ■ protect this product from excessive heat and direct sun

    ■ may stain or damage some fabrics or surfaces

  • Inactive ingredients

    water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-27, silica, phenoxyethanol,

    isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, neopentyl glycol

    diheptanoate, behenyl alcohol, tocopherol, acrylates/C10-30 alkyl acrylate

    crosspolymer, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium

    hydroxide, fragrance, disodium EDTA, sodium ascorbyl phosphate

  • Questions?

    1-866-288-3330

  • PRINCIPAL DISPLAY PANEL

    Coppertone ® Suncreen Lotion

    Sport 50

    4-IN-1 Performance

    Stops up to 98% UV Rays

    +Resists

    Sweat+Heat+Water

    Free of Oxybenzone, Octinoxate, PABA, Phthalates & Dyes

    Water Resistant (80 Minutes)

    Broad Spectrum SPF 50

    Sport FrontSport back

  • INGREDIENTS AND APPEARANCE
    COPPERTONE SUNSCREEN SPF 50 
    avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-4107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    PEG-20 STEARATE (UNII: NBX892EA57)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    POLYESTER-7 (UNII: 0841698D2F)  
    ISODODECANE (UNII: A8289P68Y2)  
    Product Characteristics
    Colorwhite (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-4107-389 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
    2NDC:66800-4107-7207 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
    3NDC:66800-4107-8259 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
    4NDC:66800-4107-9269 g in 1 BOTTLE, PLASTIC; 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 - Beiersdorf Inc (001177906)
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