BABY PURE AND GENTLE SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [CVS]

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BABY PURE AND GENTLE SPF 60 SUNSCREEN (TITANIUM DIOXIDE - 6.00% ZINC OXIDE - 4.70%) STICK [CVS]
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NDC 69842-333-01
Set ID 372ae3fb-fec0-4c7b-853b-12835c830311
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients                     Purpose

    Titanium Dioxide - 6.00%          Sunscreen 
    Zinc Oxide - 4.70%                    Sunscreen

  • PURPOSE

  • Uses

     helps prevent sunburn

  • WarningsFor external use only

    Do not use on damage 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 the children. If 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 SPF 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 month: Ask a doctor

  • Inactive ingredients

    Aluminum Hydroxide, Beeswax, BHT, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetyl Alcohol, Dimethicone, Euphorbia Cerifera (Candelilla) Wax, Isostearic Acid, Neopentyl Glycol Diethylhexanoate, Ozokerite, Paraffin, Polyethylene, Stearic Acid, Triethoxycaprylylsilane

  • Other Information

    • protect this product from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    BABY PURE AND GENTLE SPF 60 SUNSCREEN 
    titanium dioxide - 6.00% zinc oxide - 4.70% stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide6 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    Isostearic Acid (UNII: X33R8U0062)  
    Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)  
    CERESIN (UNII: Q1LS2UJO3A)  
    Paraffin (UNII: I9O0E3H2ZE)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-333-010.47 g in 1 TUBE; Type 0: Not a Combination Product02/13/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/13/2013
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-333) , label(69842-333)
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