Label: BAREMINERALS ADVANCED PROTECTION SPF 20 MOISTURIZER COMBINATION SKIN- titanium dioxide and zinc oxide 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 February 10, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium dioxide 5%Sunscreen
    Zinc oxide 3%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

    Acacia Dealbata Flower/Stem Extract, Alumina, Aluminum Stearate, Aspalathus Linearis Extract, Aspalathus Linearis Leaf Extract, Bambusa Arundinacea Stem Powder, Camellia Oleifera Leaf Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Methicone, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Ethylhexanoate, Chamomilla Recutita (Matracaria) Flower Extract, Chondrus Crispus (Carrageenan) Extract, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Coco-Caprylate/Caprate, Coffea Arabica (Coffee) Seed Extract, Cymbopogon Martini Oil, Dicaprylyl Ether, Ectoin, Ethylhexylglycerin, Geraniol, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glycine Soja (Soybean) Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Jojoba Esters, Laminaria Ochroleuca Extract, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Limonene, Linalool, Methylisothiazolinone, Phenoxyethanol, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Propanediol, Prunus Armeniaca (Apricot) Kernel Oil, Pyrus Malus (Apple) Fruit Extract, Silica, Sodium Benzoate, Sodium Citrate, Sodium Stearoyl Glutamate, Soil Minerals, Spiraea Ulmaria Extract, Tocopherol, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Water, Xanthan Gum.

  • 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 Carton

    bareMinerals

    ADVANCED
    PROTECTION
    SPF 20
    MOISTURIZER

    COMBINATION
    SKIN

    50 mL / 1.7 Fl. Oz.

    Principal Display Panel - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS ADVANCED PROTECTION SPF 20 MOISTURIZER   COMBINATION SKIN
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide50 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA DEALBATA FLOWER (UNII: 4025U039M3)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    ECTOINE (UNII: 7GXZ3858RY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GERANIOL (UNII: L837108USY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    APPLE (UNII: B423VGH5S9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-720-011 in 1 CARTON
    150 mL in 1 BOTTLE
    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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