Label: SPF 20 LOOSE MINERAL FOUNDATION- 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 November 5, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Titanium Dioxide 18.6% Sunscreen
    Zinc Oxide 5.9% Sunscreen
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  • 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.
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  • 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.

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  • Directions

    • Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
    • Reapply:
      • After 80 minutes of swimming or sweating.
      • Immediately after towel drying.
      • 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 value 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.
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  • Inactive ingredients

    Mica, Methicone, Calcium Silicate, Dimethicone, Triethoxycaprylylsilane, Sodium Sulfate, Bismuth Oxychloride (CI 77163), Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77491, CI 77492, CI 77499)

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  • Other information

    • Protect this product from excessive heat and direct sun.
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  • Questions or comments?

    Call toll free 866.426.5673

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  • SPL UNCLASSIFIED SECTION

    Manufactured by
    Colorescience®
    Carlsbad, CA 92011

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  • PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

    colorescience®

    LOOSE
    MINERAL
    FOUNDATION

    Breathable formula
    Self-dispensing brush
    Water resistant
    (80 minutes)

    20
    Broad Spectrum
    SPF 20
    Sunscreen

    Net Wt. 6 g / 0.21 oz.

    PRINCIPAL DISPLAY PANEL - 6 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    SPF 20 LOOSE MINERAL FOUNDATION 
    titanium dioxide and zinc oxide powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-000
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 186 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 59 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Mica (UNII: V8A1AW0880)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Methicone (20 CST) (UNII: 6777U11MKT)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Calcium Silicate (UNII: S4255P4G5M)  
    Chromic Oxide (UNII: X5Z09SU859)  
    Sodium Sulfate (UNII: 0YPR65R21J)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68078-000-01 1 in 1 CARTON 10/01/2015
    1 6 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 10/01/2015
    Labeler - Colorescience (128731929)
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