Label: MINERAL WEAR- titanium dioxide, zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL

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 9, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients                                                         Purpose

    Titanium Dioxide 6.0%, Zinc Oxide 4.2% ....................... Sunscreen

  • PURPOSE

    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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Physicians Formula

    Mineral Wear

    Talc-Free Mineral Face Powder

    SPF 16 Broad Spectrum Sunscreen

    Minimalist formula helps reduce irritation & breakout.

    Net Wt. 0.3 oz / 9g

    For extra sensitive or breakout-prone skin!

    Recommended as an effective broad spectrum sunscreen

    HYPOALLERGENIC

    FRAGRANCE FREE

    GLUTEN FREE

    NON-COMEDOGENIC

    DERMATOLOGIST APPROVED

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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

    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 am - 2pm
    • wear long-sleeve pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    mica, squalane, silica, lauroyl lysine, boron nitride, kaolin, retinyl palmitate, tocopheryl acetate, dehydroacetic acid. may contain: titanium dioxide, iron oxides, chromium hydroxide green.

  • OTHER SAFETY INFORMATION

    Other Information: protect this product from excessive heat and direct sun

    Questions or comments?  Call toll-free 1-800-227-0333

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    MINERAL WEAR 
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69184-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    SQUALANE (UNII: GW89575KF9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    KAOLIN (UNII: 24H4NWX5CO)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69184-002-019 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/08/2014
    Labeler - Mei Shual Cosmetics Co., Ltd. (656375912)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mei Shual Cosmetics Co., Ltd.656375912manufacture(69184-002)