Label: BRUSH ON BLOCK MINERAL POWDER SUNSCREEN TRANSLUCENT- 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 January 20, 2023

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  • Active Ingredients

    Titanium Dioxide 6%

    Zinc Oxide 21%

  • Purpose

    Sunscreen

  • Uses

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

    For external use only.

    Do not use

    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

    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

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply: • after 80 minutes of swimming or sweating • Immediately after towel drying • 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10am - 2pm • Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor
  • Inactive Ingredients

    Bisabolol, Boron Nitride, Chamomile Flower Extract, Ethyl Ferulate, Hydroxyacetophenone, Iron Oxides, Lauroyl Lysine, Mica, Phenyl Trimethicone, Rice Bran Extract, Safflower Seed Oil, Silica, Sodium Dehydroacetate, Triethoxycaprylylsilane.

  • Other Information

    Protect the product in this container from excessive heat and direct sun.

  • Questions or Comments?

    Contact our specialists at (800) 916-7690

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BRUSH ON BLOCK MINERAL POWDER SUNSCREEN TRANSLUCENT 
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58274-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.21 g  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.06 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    MICA (UNII: V8A1AW0880)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58274-011-013.4 g in 1 TUBE; Type 0: Not a Combination Product01/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/20/2023
    Labeler - SPF Ventures, LLC (055483891)
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