Label: BAREMINERALS ADVANCED PROTECTION SPF 20 MOISTURIZER NORMAL TO DRY SKIN- titanium dioxide lotion

  • 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 December 18, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Titanium dioxide 6%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • 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
    • Children under 6 months: ask a doctor
  • Inactive ingredients

    Aluminum Hydroxide, Anthemis Nobilis Flower Oil, Ascorbic Acid, Benzyl Benzoate, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl Hydroxyethylcellulose, Cetyl PEG/PPG-10/1 Dimethicone, Citronellol, Coumarin, Dicaprylyl Carbonate, Disteardimonium Hectorite, Epilobium Angustifolium Flower/Leaf/Stem Extract, Ethylhexylglycerin, Eugenol, Geraniol, Glycerin, Glycine Soja (Soybean) Oil, Isostearic Acid, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Lecithin, Limonene, Linalool, Phenoxyethanol, Phytoecdysteroids, Polyglyceryl-2 Diisostearate, Polymethyl Methacrylate, Polymethylsilsesquioxane, Potassium Sorbate, Propanediol, Retinyl Palmitate, Sinorhizobium Meliloti Ferment Filtrate, Sodium Benzoate, Sodium Metabisulfite, Soil Minerals, Stearic Acid, Tocopherol, Tocopheryl Acetate, Triethylhexanoin, Trisodium EDTA, Water, Zizyphus Jujuba Seed Extract.

  • 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 - 50 mL Bottle Box

    bareMinerals

    ADVANCED
    PROTECTION
    SPF 20
    MOISTURIZER

    NORMAL TO DRY
    SKIN

    50 mL / 1.7 Fl. Oz.

    Principal Display Panel - 50 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS ADVANCED PROTECTION SPF 20 MOISTURIZER  NORMAL TO DRY SKIN
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-722
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    COUMARIN (UNII: A4VZ22K1WT)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EUGENOL (UNII: 3T8H1794QW)  
    GERANIOL (UNII: L837108USY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    WATER (UNII: 059QF0KO0R)  
    JUJUBE SEED (UNII: I51YGQ1Q2L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-722-011 in 1 BOX12/31/2013
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/31/2013
    Labeler - Bare Escentuals Beauty, Inc. (087008363)
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