Label: SUNFORGETTABLE TOTAL PROTECTION SHEET MATTE SUNSCREEN SPF 30- 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 July 31, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Zinc Oxide 22.5%

  • 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 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.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • 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, Methicone, Maltodextrin, Silica, Glycerin, Club Moss (Lycopodium Clavatum) Extract, Sodium Hyaluronate, Grape (Vitis Vinifera) Seed Extract, Green Tea (Camellia Sinensis) Leaf Extract, Oak (Quercus Robur) Wood Extract, Cogon Grass (Imperata Cylindrica) Root Extract, Water, Tara (Caesalpinia Spinosa) Fruit Pod Extract, Sunflower (Helianthus Annuus) Sprout Extract, Isoceteth-10, Triethoxycaprylylsilane, Sodium Benzoate, Potassium Sorbate, 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™

    SHEER MATTE SUNSCREEN

    +
    Protects from UVA/UVB,
    pollution, blue light, IR
    +
    Absorbs excess oil, mattifies
    +
    Mess-free application

    30 Broad Spectrum
    SPF 30 Sunscreen
    PA+++

    CHEMICAL-FREE ACTIVES | 100% MINERAL

    Net Wt. 4.3 g / 0.15 oz.

    Principal Display Panel - 4.3 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNFORGETTABLE TOTAL PROTECTION SHEET MATTE SUNSCREEN SPF 30 
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isoceteth-10 (UNII: 1K92T9919H)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    QUERCUS ROBUR TWIG BARK (UNII: 2JFK226947)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    Water (UNII: 059QF0KO0R)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68078-036-011 in 1 CARTON07/20/2020
    14.3 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 FINALpart35207/20/2020
    Labeler - Colorescience (128731929)
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