Label: BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 FAIRLY MEDIUM 05- titanium dioxide and zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient(s)Purpose
    Titanium dioxide 25%Sunscreen
    Zinc oxide 9.3%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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • children under 6 months: ask a doctor
    • 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-sleeved shirts, pants, hats, and sunglasses.
  • Other information

    Protect this product from excessive heat and direct sun

  • Inactive ingredients

    bismuth oxychloride, titanium dioxide, mica, iron oxides.

  • Questions or comments?

    Call toll free 1-888-795-4747

  • PRINCIPAL DISPLAY PANEL - 8 g Jar Label

    bareMinerals ®

    ORIGINAL FOUNDATION
    Broad Spectrum SPF 15

    FAIRLY MEDIUM 05

    net wt. 8 g / 0.28 oz.

    61270

    PRINCIPAL DISPLAY PANEL - 8 g Jar Label
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15  FAIRLY MEDIUM 05
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2000 mg  in 8 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE744 mg  in 8 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-018-088 g in 1 JAR; Type 0: Not a Combination Product08/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/01/2021
    Labeler - Orveon Global US LLC (118344494)
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