Label: BABY SPF 60 SUNSCREEN- titanium dioxide - 6.00% zinc oxide - 4.70% stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 14, 2018

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  • Active ingredients                     Purpose

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

  • PURPOSE

  • 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

  • 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

  • Questions or comments?

    1-866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BABY SPF 60 SUNSCREEN 
    titanium dioxide - 6.00% zinc oxide - 4.70% stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3216
    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:0363-3216-0114.2 g in 1 BOTTLE; 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 - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-3216) , label(0363-3216)
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