Label: FAIRLY MEDIUM FOUNDATION SPF 15- titanium dioxide, zinc oxide powder

  • 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 4, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • Active Ingredients

    Zinc Oxide 9.3%
    Titanium Dioxide 25%

  • Purpose

    Sunscreen
    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 on damage or broken skin
    • When using this product keep out of eyes. Rinse with water to remove
    • Stop use and ask 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
    • Use a water-resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: ask a doctor
    • Sun protection measures. Spending time in the sun increases your risk of skin cancer or early skin aging. To decrease this risk, regularly use a a sunscreen with a broad spectrum 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
  • Inactive Ingredients

    Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide

  • Questions or Comments?

    Call toll free 1-888-795-4747
  • PRINCIPAL DISPLAY PANEL

    LabelLabelLabel

  • INGREDIENTS AND APPEARANCE
    FAIRLY MEDIUM FOUNDATION SPF 15 
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-924
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide9.3 g  in 100 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-924-0872 in 1 CASE
    18 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/12/2012
    Labeler - Bare Escentuals Beauty Inc. (087008363)
    Registrant - Ei Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei Inc.105803274manufacture(98132-924) , label(98132-924)
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