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

  • NDC Code(s): 66800-4109-0, 66800-4109-1, 66800-4109-2, 66800-4109-3, view more
    66800-4109-6, 66800-4109-8, 66800-4109-9
  • Packager: Beiersdorf Inc
  • Category: HUMAN OTC DRUG LABEL

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 10, 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, aloe barbadensis leaf juice, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, styrene/acrylates copolymer, butylene glycol,

    VP/Eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, fragrance, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

  • Questions?

    1-866-288-3330

  • PRINCIPAL DISPLAY PANEL

    #1 Pediatrician Recommended Brand

    Coppertone Sunscreen Lotion

    waterbabies

    Fragrance Free

    Hypoallergenic

    Enriched with Vitamin E

    50

    Free Of oxybenzone, octinoxate, dyes & PABA

    Water Resistant (80 Minutes)

    Broad Spectrum SPF 50

    WB Lotion

  • INGREDIENTS AND APPEARANCE
    COPPERTONE WATERBABIES SUNSCREEN SPF 50 
    avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-4109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    Product Characteristics
    Colorwhite (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-4109-130 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
    2NDC:66800-4109-259 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
    3NDC:66800-4109-388 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
    4NDC:66800-4109-6177 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
    5NDC:66800-4109-8237 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
    6NDC:66800-4109-0296 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/02/2020
    7NDC:66800-4109-9315 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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