Label: COPPERTONE PURE AND SIMPLE BABY SUNSCREEN SPF 50- zinc oxide 24.08% lotion

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

Drug Label Information

Updated November 2, 2023

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  • 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

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

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

  • 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

    ■ 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, 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, tocopherol, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, 1,2-hexanediol, caprylyl glycol

  • Questions?

    1-866-288-3330

  • PRINCIPAL DISPLAY PANEL

    Coppertone

    Zinc Oxide Sunscreen

    Pure&Simple

    #1 Pediatrician Recommended Sunscreen Brand

    Baby

    50

    100% Mineral Sun Protection

    Hypoallergenic & Tear Free Suitable for Sensitive Skin

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

    Water Resistant (80 Minutes)

    Broad Spectrum SPF 50

    PS Baby Lotion1

  • INGREDIENTS AND APPEARANCE
    COPPERTONE PURE AND SIMPLE BABY SUNSCREEN SPF 50 
    zinc oxide 24.08% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-2871
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL PELARGONATE (UNII: 3YU1SQ04DV)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    POLYESTER-7 (UNII: 0841698D2F)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
    Product Characteristics
    Colorwhite (White to Off-White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66800-2871-7177 g in 1 TUBE; Type 0: Not a Combination Product12/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/06/2023
    Labeler - Beiersdorf Inc (001177906)
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