Label: BAREMINERALS PREP STEP MINERAL SHIELD BROAD SPECTRUM SPF 50 DAILY PREP- zinc oxide and 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 March 4, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient(s)Purpose
    Zinc oxide 23.8%Sunscreen
    Titanium dioxide 4.1%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

    coconut alkanes, caprylyl caprylate/caprate, water, squalane, adipic acid/neopentyl glycol crosspolymer, polyglyceryl-2 diisostearate, silica, glycerin, propanediol, sorbitan sesquiisostearate, isostearic acid, coco-caprylate/caprate, triethoxycaprylylsilane, gentiana urnula flower extract, moringa oleifera seed extract, butylene glycol, magnesium hydroxide, sodium citrate, citric acid, polyester-1, silica dimethyl silylate, disodium phosphate, phenoxyethanol. may contain: mica, titanium dioxide, 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 - 40 mL Bottle Carton

    bareMinerals®
    PREP STEP™

    MINERAL SHIELD

    BROAD SPECTRUM
    SPF 50

    DAILY PREP LOTION

    Principal Display Panel - 40 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS PREP STEP MINERAL SHIELD BROAD SPECTRUM SPF 50 DAILY PREP 
    zinc oxide and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-761
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide238 mg  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide41 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    coconut alkanes (UNII: 1E5KJY107T)  
    caprylyl caprylate/caprate (UNII: 22MCG4RSMR)  
    water (UNII: 059QF0KO0R)  
    squalene (UNII: 7QWM220FJH)  
    polyglyceryl-2 diisostearate (UNII: DG195GP57P)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    glycerin (UNII: PDC6A3C0OX)  
    propanediol (UNII: 5965N8W85T)  
    isostearic acid (UNII: X33R8U0062)  
    coco-caprylate/caprate (UNII: 8D9H4QU99H)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    gentiana urnula flower (UNII: 2RIZ3HY23X)  
    moringa oleifera seed (UNII: TIX5482832)  
    butylene glycol (UNII: 3XUS85K0RA)  
    magnesium hydroxide (UNII: NBZ3QY004S)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    silica dimethyl silylate (UNII: EU2PSP0G0W)  
    sodium phosphate, dibasic, anhydrous (UNII: 22ADO53M6F)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    mica (UNII: V8A1AW0880)  
    ferric oxide red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-761-011 in 1 CARTON
    140 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/01/2015
    Labeler - Bare Escentuals Beauty, Inc. (087008363)
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