Label: COPPERTONE WATERBABIES PURE AND SIMPLE SUNSCREEN SPF 50- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 24, 2023

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  • Drug Facts

  • Active ingredients

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

  • 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, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol, VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, aloe barbadensis leaf juice,

    tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide,

    disodium EDTA, sodium ascorbyl phosphate

  • Questions?

    1-866-288-3330

  • PRINCIPAL DISPLAY PANEL

    NEW

    #1 Pediatrician Recommended Sunscreen Brand
    Coppertone® Sunscreen Lotion

    water babies Pure&Simple Light Lotion

    SPF50 PA++++

    Formulated with Vitamin C + E

    No Added Fragrance, Parabens, Oxybenzone, Octinoxate & PABA

    Water Resistant (80 Minutes)

    Broad Spectrum SPF 50

    6 FL OZ (177 mL)

    WB Light Lotion Export

  • INGREDIENTS AND APPEARANCE
    COPPERTONE WATERBABIES PURE AND SIMPLE SUNSCREEN SPF 50 
    avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-4840
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Colorwhite (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-4840-7177 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/29/2021
    Labeler - Beiersdorf Inc (001177906)
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