Label: BAREMINERALS DAILY DEFENSE BROAD SPECTRUM SPF 30- 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 12, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient(s)Purpose
    Titanium dioxide 3%Sunscreen
    Zinc oxide 15.3%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 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

    For sunscreen use:

    • 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 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
  • Inactive ingredients

    water/aqua, caprylic/capric triglyceride, squalane, butylene glycol, isopropyl myristate, SD alcohol 40-B (alcohol denat.), dimethicone, glycerin, PPG-3 dipivalate, PEG-100 hydrogenated castor oil, silica, isostearic acid, triethoxycaprylylsilane, hydrated silica, phenoxyethanol, sorbitan sesquiisostearate, dimethylacrylamide/sodium acryloyldimethyltaurate crosspolymer, cellulose gum, succinoglycan, sodium metaphosphate, PEG/PPG-14/7 dimethyl ether, citric acid, disodium EDTA, alcohol, distearyldimonium chloride, soil minerals, sodium citrate, rosmarinus officinalis (rosemary) leaf oil, thymus serpillum extract, citrus aurantium dulcis (orange) oil, tocopherol, sodium acetylated hyaluronate, rosa canina fruit extract, betula platyphylla japonica bark extract, sophora angustifolia root extract, iron oxides.

  • 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 - 25 mL Tube Carton

    bareMinerals

    DAILY DEFENSE
    BROAD SPECTRUM
    SPF 30

    25 ml / 0.84 fl. oz.

    Principal Display Panel - 25 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS DAILY DEFENSE BROAD SPECTRUM SPF 30 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-724
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide1530 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SQUALANE (UNII: GW89575KF9)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    THYMUS SERPYLLUM (UNII: 86H4S6K51N)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    BETULA PLATYPHYLLA BARK (UNII: ZF70YKN0YO)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-724-011 in 1 CARTON
    125 mL in 1 TUBE
    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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