Label: BRUSH ON BLOCK MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide 15%, zinc oxide 12% cream

  • 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 October 15, 2015

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  • Drug Facts

    Active Ingredients

    Titanium Dioxide 15%

    Zinc Oxide 12%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun
  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before sun exposure
    • reapply: after 80 minutes of swimming or sweating, immediately after towel drying, and 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 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. and wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

  • 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

  • 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

  • QUESTIONS

    Questions or Comments?

    Call toll free 1-800-916-7690

  • OTHER SAFETY INFORMATION

    Other Information

    • protect this product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL

    Brush on Block

    Mineral Sunscreen

    Broad Spectrum SPF 30

    UVA/UVB Protection

    Water Resistant (80 MIN)

    NET WT 3.4 G/.12 OZ

    BRUSHONBLOCK.COM

    carton

  • INGREDIENTS AND APPEARANCE
    BRUSH ON BLOCK MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide 15%, zinc oxide 12% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58274-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE15 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    RICE BRAN (UNII: R60QEP13IC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58274-006-013.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/19/2013
    Labeler - SPF Ventures, LLC (055483891)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics001321058manufacture(58274-006)
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