Label: COPPERTONE WATERBABIES PURE AND SIMPLE SUNSCREEN SPF 50- zinc oxide 24.08% spray

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

Drug Label Information

Updated October 18, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Zinc Oxide 24.08%

  • Purpose

    Sunscreen

  • 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

    For external use only
    Flammable: Do not use near heat, flame, or while smoking

  • WHEN USING

    When using this product
    ■ keep away from face to avoid breathing it

    ■ keep out of eyes. Rinse with water to remove.

    ■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    ■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.

  • 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

    ■ shake well before each use

    ■ spray liberally and spread evenly by hand 15 minutes before sun exposure

    ■ hold container 4 to 6 inches from the skin to apply

    ■ do not spray directly into face. Spray on hands then apply to face.

    ■ do not apply in windy conditions

    ■ use in a well-ventilated area

    ■ 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

    ■ store between 20˚ to 25˚C (68˚ to 77˚F)

    ■ may stain or damage some fabrics or surfaces

  • Inactive ingredients

    isobutane, water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl pelargonate, ethylhexyl methoxycrylene, polyester-27, cetyl dimethicone, triethoxycaprylylsilane, beeswax, tocopherol (vitamin E), hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, 1,2-hexanediol, caprylyl glycol, caprylyl methicone

  • Questions?

    1-866-288-3330

  • PRINCIPAL DISPLAY PANEL

    Coppertone

    Zinc Oxide Snscreen Spray

    Pure&Simple

    50

    100% Mineral Sun Protection

    Hypoallergenic

    Suitable for Sensitive Skin

    Free of Oxybenzone, Octinoxate, PABA, Parabens, Dyes, Fragrance

    Water Resistant (80 Minutes)

    Broad Spectrum SPF 50

    PS Spray

  • INGREDIENTS AND APPEARANCE
    COPPERTONE WATERBABIES PURE AND SIMPLE SUNSCREEN SPF 50 
    zinc oxide 24.08% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-2880
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.08 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRIMETHICONE (UNII: H6HK6E4EB1)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOBUTANE (UNII: BXR49TP611)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
    POLYESTER-7 (UNII: 0841698D2F)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYL PELARGONATE (UNII: 3YU1SQ04DV)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    Colorwhite (White to Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-2880-5142 g in 1 CAN; Type 0: Not a Combination Product11/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/03/2023
    Labeler - Beiersdorf Inc (001177906)