Label: MINERAL SPF 30 BRUSH-ON SUN DEFENSE- titanium dioxide and zinc oxide powder

  • 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 December 31, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Titanium Dioxide 17.3%Sunscreen
    Zinc Oxide 20.0%Sunscreen
  • Uses

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
  • Warnings

    • When using this product keep out of eyes.
    • Rinse with water to remove.
    • Stop use and ask doctor if rash or irritation develops and lasts.

    • Keep out of reach of children.
  • Directions

    • Apply liberally 15 minutes before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
  • Inactive Ingredients

    Mica, Silica, Nylon-12, Caprylic/Capric Triglyceride, Tocopherol, Capryloyl Glycine, Undecylenoyl Glycine, Alaria Esculenta (Sea Kelp) Extract, Retinyl Palmitate, Iron Oxides.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    Call toll free 1-800-428-1668 Mon-Fri 8 AM-5 PM PST

  • SPL UNCLASSIFIED SECTION

    Dist. by Mineral Fusion
    Petaluma, CA 94954 USA

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

    Mineral SPF 30
    Brush-On Sun Defense

    Translucent Matte Finish
    For All Skin Tones
    Broad Spectrum Protection

    MINERAL
    FUSION®

    BRUSH-ON
    SPF 30
    PROTECTION

    Making Beauty Healthy®

    Net Wt 0.14 oz e 4.0 g

    Principal Display Panel - 4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MINERAL SPF 30 BRUSH-ON SUN DEFENSE 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-1221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE173 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NYLON-12 (UNII: 446U8J075B)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)  
    ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55789-1221-11 in 1 CARTON12/31/2019
    14 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/31/2019
    Labeler - Mineral Fusion brands (831770032)
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