Label: SUNFORGETTABLE TOTAL PROTECTION BRUSH-ON SHIELD SPF 50- titanium dioxide and zinc oxide powder

  • NDC Code(s): 68078-027-01, 68078-027-02, 68078-027-03
  • Packager: Colorescience
  • 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 19, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose   
    Titanium Dioxide 22.5%Sunscreen
    Zinc Oxide 22.5%Sunscreen
  • 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.
  • 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.

  • 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 of age:
      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.
  • Inactive ingredients

    Mica, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol/Propylsilsequioxane/Silicate Crosspolymer, Lycopodium Clavatum Extract, Sodium Hyaluronate, Imperata Cyclindrica Root Extract, Glycerin, Water, Caesalpinia Spinosa Fruit Pod Extract, Vitis Vinifera (Grape) Seed Extract, Camellia Sinensis Leaf Extract, Quercus Robur (Oak) Wood Extract, Helianthus Annuus (Sunflower) Sprout Extract, Maltodextrin, Methicone, Triethoxycaprylylsilane, Laureth-4, Sodium Benzoate, Potassium Sorbate, Chromium Oxide Greens (CI 77288), Iron Oxides (CI77491, CI 77492, CI 77499)

  • Other information

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

    Call toll free 866.426.5673

  • SPL UNCLASSIFIED SECTION

    Distributed in USA by
    colorescience®
    Carlsbad, CA 92011

  • PRINCIPAL DISPLAY PANEL - 4.3 g Tube Carton

    colorescience®

    SUNFORGETTABLE®
    TOTAL PROTECTION®

    BRUSH-ON SHIELD BRONZE

    +
    Protects from: UVA/UVB,
    pollution, blue light, IR
    +
    Natural-looking bronze tint
    +
    Hydrating, antioxidant-rich

    50
    Broad Spectrum
    SPF 50 Sunscreen
    PA++++

    ALL-MINERAL ACTIVES
    WATER/SWEAT RESISTANT (80 MINUTES)

    Net Wt. 4.3 g / 0.15 oz.

    Principal Display Panel - 4.3 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNFORGETTABLE TOTAL PROTECTION BRUSH-ON SHIELD SPF 50 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide225 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide225 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Mica (UNII: V8A1AW0880)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Hard Particle) (UNII: H895X08VNQ)  
    Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer (450000000 MW) (UNII: 9KB5R958PB)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Methicone (20 CST) (UNII: 6777U11MKT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Laureth-4 (UNII: 6HQ855798J)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Imperata Cylindrica Root (UNII: VYT2JA85NH)  
    Water (UNII: 059QF0KO0R)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Vitis Vinifera Seed (UNII: C34U15ICXA)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Quercus Robur Twig Bark (UNII: 2JFK226947)  
    Caesalpinia Spinosa Resin (UNII: WL3883U2PO)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Chromic Oxide (UNII: X5Z09SU859)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68078-027-011 in 1 CARTON04/01/2018
    16 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:68078-027-022 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product04/01/2018
    3NDC:68078-027-031 in 1 CARTON04/01/2022
    34.3 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 FINALpart35201/31/2018
    Labeler - Colorescience (128731929)
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