Label: BAREMINERALS SPF 20 CORRECTING CONCEALER- titanium dioxide cream

  • 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 May 25, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Titanium dioxide 15%

  • 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

    • Skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early aging
    • This product has been shown only to help prevent sunburn, not skin cancer or early aging
    • For external use only

    • Do not use on damaged 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 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
    • 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 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
  • Inactive ingredients

    Alumina, Bismuth Oxychloride, Butylene/Ethylene/Styrene Copolymer, Calcium Aluminum Borosilicate, Cetyl Esters, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) Wax (Candelilla Cera / Cire de Candelilla), HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogen Dimethicone, Hydrogenated Polyisobutene, Iron Oxides, Isocetyl Alcohol, Isodecyl Isononanoate, Lactobacillus/Lemon Peel Ferment Extract, Lauryl PCA, Lecithin, Mica, Octadecenedioic Acid, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Polymethylsilsesquioxane, Saccharomyces/Copper Ferment, Silica, Titanium Dioxide, Tocopheryl Acetate, Trioctyldodecyl Citrate, VP/Hexadecene Copolymer.

  • Other information

    • Protect this product from excessive heat and direct sun
  • Questions or comments?

    Call toll free 1-888-795-4747

  • SPL UNCLASSIFIED SECTION

    Dist. by Bare Escentuals Beauty, Inc., SF, CA 94105 USA

  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - LIGHT 1

    bareMinerals®

    SPF 20 CORRECTING
    CONCEALER

    2 g / 0.07 Oz.

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - LIGHT 1
  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - LIGHT 2

    bareMinerals®

    SPF 20 CORRECTING
    CONCEALER

    2 g / 0.07 Oz.

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - LIGHT 2
  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - MEDIUM 1

    bareMinerals®

    SPF 20 CORRECTING
    CONCEALER

    2 g / 0.07 Oz.

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - MEDIUM 1
  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - MEDIUM 2

    bareMinerals®

    SPF 20 CORRECTING
    CONCEALER

    2 g / 0.07 Oz.

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - MEDIUM 2
  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - TAN 1

    bareMinerals®

    SPF 20 CORRECTING
    CONCEALER

    2 g / 0.07 Oz.

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - TAN 1
  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - TAN 2

    bareMinerals®

    SPF 20 CORRECTING
    CONCEALER

    2 g / 0.07 Oz.

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - TAN 2
  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - DARK 2

    bareMinerals®

    SPF 20 CORRECTING
    CONCEALER

    2 g / 0.07 Oz.

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - DARK 2
  • PRINCIPAL DISPLAY PANEL - 2 g Container Carton - DEEP 2

    bareMinerals®

    SPF 20 CORRECTING
    CONCEALER

    2 g / 0.07 Oz.

    PRINCIPAL DISPLAY PANEL - 2 g Container Carton - DEEP 2
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS   SPF 20 CORRECTING CONCEALER
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-664
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.3 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Isocetyl Alcohol (UNII: 1800H64066)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Octadecenedioic Acid (UNII: 565ZMT5QRG)  
    Candelilla Wax (UNII: WL0328HX19)  
    Lauryl PCA (UNII: 29C5O2BJYA)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Mica (UNII: V8A1AW0880)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    ColorBROWN (Light 1) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-664-011 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/26/2012
    BAREMINERALS   SPF 20 CORRECTING CONCEALER
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-665
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.3 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Isocetyl Alcohol (UNII: 1800H64066)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Octadecenedioic Acid (UNII: 565ZMT5QRG)  
    Candelilla Wax (UNII: WL0328HX19)  
    Lauryl PCA (UNII: 29C5O2BJYA)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Mica (UNII: V8A1AW0880)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    ColorBROWN (Light 2) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-665-011 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/26/2012
    BAREMINERALS   SPF 20 CORRECTING CONCEALER
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-666
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.3 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Isocetyl Alcohol (UNII: 1800H64066)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Octadecenedioic Acid (UNII: 565ZMT5QRG)  
    Candelilla Wax (UNII: WL0328HX19)  
    Lauryl PCA (UNII: 29C5O2BJYA)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Mica (UNII: V8A1AW0880)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    ColorBROWN (Medium 1) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-666-011 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/26/2012
    BAREMINERALS   SPF 20 CORRECTING CONCEALER
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-667
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.3 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Isocetyl Alcohol (UNII: 1800H64066)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Octadecenedioic Acid (UNII: 565ZMT5QRG)  
    Candelilla Wax (UNII: WL0328HX19)  
    Lauryl PCA (UNII: 29C5O2BJYA)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Mica (UNII: V8A1AW0880)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    ColorBROWN (Medium 2) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-667-011 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/26/2012
    BAREMINERALS   SPF 20 CORRECTING CONCEALER
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-668
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.3 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Isocetyl Alcohol (UNII: 1800H64066)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Octadecenedioic Acid (UNII: 565ZMT5QRG)  
    Candelilla Wax (UNII: WL0328HX19)  
    Lauryl PCA (UNII: 29C5O2BJYA)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Mica (UNII: V8A1AW0880)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    ColorBROWN (Tan 1) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-668-011 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/26/2012
    BAREMINERALS   SPF 20 CORRECTING CONCEALER
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-669
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.3 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Isocetyl Alcohol (UNII: 1800H64066)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Octadecenedioic Acid (UNII: 565ZMT5QRG)  
    Candelilla Wax (UNII: WL0328HX19)  
    Lauryl PCA (UNII: 29C5O2BJYA)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Mica (UNII: V8A1AW0880)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    ColorBROWN (Tan 2) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-669-011 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/26/2012
    BAREMINERALS   SPF 20 CORRECTING CONCEALER
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-670
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.3 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Isocetyl Alcohol (UNII: 1800H64066)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Octadecenedioic Acid (UNII: 565ZMT5QRG)  
    Candelilla Wax (UNII: WL0328HX19)  
    Lauryl PCA (UNII: 29C5O2BJYA)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Mica (UNII: V8A1AW0880)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    ColorBROWN (Dark 2) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-670-011 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/26/2012
    BAREMINERALS   SPF 20 CORRECTING CONCEALER
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-671
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.3 g  in 2 g
    Inactive Ingredients
    Ingredient NameStrength
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Isocetyl Alcohol (UNII: 1800H64066)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Octadecenedioic Acid (UNII: 565ZMT5QRG)  
    Candelilla Wax (UNII: WL0328HX19)  
    Lauryl PCA (UNII: 29C5O2BJYA)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Mica (UNII: V8A1AW0880)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    ColorBROWN (Deep 2) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-671-011 in 1 CARTON
    12 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/26/2012
    Labeler - Bare Escentuals Beauty Inc. (087008363)