Label: COPPERTONE SPORT SUNSCREEN SPF 30- avobenzone 3%, homosalate 8%, octisalate 4.5%, octocrylene 6% lotion

  • NDC Code(s): 66800-2669-3, 66800-2669-7, 66800-2669-8, 66800-2669-9
  • 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 March 5, 2023

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  • Drug Facts

  • Active ingredients

    Avobenzone 3%, Homosalate 8%, Octisalate 4.5%, Octocrylene 6%

  • 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

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

  • Questions?

    1-866-288-3330

  • PRINCIPAL DISPLAY PANEL

    Coppertone ® Sunscreen Lotion

    Sport 30

    4-IN-1 Performance

    Stops up to 97% UV Rays

    +Resists

    Sweat+Heat+Water

    Free of Oxybenzone, Octinoxate, PABA, Phthalates & Dyes

    Water Resistant (80 Minutes)

    Broad Spectrum SPF 30

    Sport 30 frontSport 30 rear

  • INGREDIENTS AND APPEARANCE
    COPPERTONE SPORT SUNSCREEN SPF 30 
    avobenzone 3%, homosalate 8%, octisalate 4.5%, octocrylene 6% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-2669
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISODODECANE (UNII: A8289P68Y2)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    PEG-20 STEARATE (UNII: NBX892EA57)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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:66800-2669-388 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
    2NDC:66800-2669-7207 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
    3NDC:66800-2669-8259 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
    4NDC:66800-2669-9269 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 not finalpart35211/02/2020
    Labeler - Beiersdorf Inc (001177906)
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