Label: BAREMINERALS NATURAL SUNSCREEN MEDIUM- titanium dioxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 6, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Uses

    Helps prevent sunburn. Higher SPF gives more sunburn protection.

  • Active Ingredients

    Titanium Dioxide 12%

  • Purpose

    Sunscreen

  • Warnings

    For external use only

    When using this product

    Keep out of Eyes ; Rinse with water to remove

    Stop use and ask a doctor if

    Rash or irritation develops or lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply evenly before sun exposure as needed.

  • STORAGE AND HANDLING

    Other information: Store at room temperature (59° to 86° F)

  • Inactive Ingredients

    ASCORBY PALMITATE, TOCOPHERYL ACETATE, RETINYL PALMITATE, ALOE BARBADENIS LEAF EXTRACT, LYCIUM CHINESIS (LYCII BERRY) EXTRACT, RANUNCULLUS FICARIA ROOT EXTRACT, SILICA, (+/-) Mica, IRON OXIDES (CI77491, CI 77499), ULTRAMARINES (CI77007), TITANIUM DIOXIDE (CI 77891), BISMUTH OXYCLORIDE (CI 77163)

  • SPL UNCLASSIFIED SECTION

    Distr. By Bare Escentuals Beauty Inc., San Francisco CA 94104 USA

  • PRINCIPAL DISPLAY PANEL - 4 g Jar Carton

    bareMinerals

    spf30
    NATURAL
    SUNSCREEN

    UVA/UVB
    PROTECTION

    FOR MEDIUM
    SKIN TONES

    Face/Body
    4 g/0.14 Oz

    Principal Display Panel - 4 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS   NATURAL SUNSCREEN MEDIUM
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Tocopherol (UNII: R0ZB2556P8)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Aloe (UNII: V5VD430YW9)  
    Lycium Chinense Root Bark (UNII: 2Q9D9P290N)  
    Ranunculus Ficaria (UNII: YO2M043F0W)  
    Mica (UNII: V8A1AW0880)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-123-044 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/31/2009
    Labeler - Bare Escentuals Beauty Inc. (087008363)
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