EVEN UP SUNSCREEN SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]

EVEN UP SUNSCREEN SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LIQUID [COLORESCIENCE]
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NDC 68078-003-02, 68078-003-04
Set ID f9d375af-3c8b-4462-b729-fdd4be929284
Category HUMAN OTC DRUG LABEL
Packager Colorescience
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 11.6%Sunscreen
    Zinc Oxide 8.6%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 40 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.
  • Inactive ingredients

    Cyclopentasiloxane, Isocetyl Stearoyl Stearate, Dimethicone Crosspolymer, Thermus Thermophillus Ferment, Water/Aqua/Eau, Hydrated Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium Lauriminodipropionate Tocopheryl Phosphates, Panthenyl Triacetate, Acetyl Rheum Rhaponticum Root Extract, Bidens Pilosa Extract, Elaeis Guineensis (Palm) Oil, Gossypium Herbaceum (Cotton) Seed Oil, Linum Usitatissimum (Linseed) Seed Oil, Tocopherol, Dimethiconol, Citrus Paradisi (Grapefruit) Seed Extract, Glycerin, Dimethicone, Fusanus Spicatus Wood Oil, Vanilla Planifolia Fruit Extract, Ascorbic Acid, Caprylic/Capric Triglyceride, Pentylene Glycol, Triethoxycaprylylsilane, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Potassium Sorbate, Farnesol, Iron Oxides (CI 77491, 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

    Dist. in USA by
    colorescience®
    Carlsbad, CA 92011

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    colorescience®

    EVEN UP®

    CLINICAL PIGMENT
    PERFECTOR®

    Brightens with Lumira®
    ingredient complex

    Improves look of discoloration

    50
    Broad Spectrum
    SPF 50
    Sunscreen

    CHEMICAL-FREE ACTIVES | 100% MINERAL
    WATER AND SWEAT RESISTANT, 40 MIN

    1 fl. oz. / 30 mL

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    EVEN UP SUNSCREEN SPF 50 
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide116 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide86 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Isocetyl Stearoyl Stearate (UNII: IJV4LS383R)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Thermus Thermophilus Lysate (UNII: 775R692494)  
    Water (UNII: 059QF0KO0R)  
    Panthenol Triacetate, (+)- (UNII: 1206E8961B)  
    Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Palm Oil (UNII: 5QUO05548Z)  
    Cottonseed Oil (UNII: H3E878020N)  
    Citrus Paradisi Seed (UNII: 12F08874Y7)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Linseed Oil (UNII: 84XB4DV00W)  
    Santalum Spicatum Oil (UNII: H9LVS6REV4)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    VANILLA BEAN (UNII: Q74T35078H)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Dehydroacetic Acid (UNII: 2KAG279R6R)  
    Tocopherol (UNII: R0ZB2556P8)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68078-003-041 in 1 CARTON10/05/2015
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68078-003-021 mL in 1 PACKET; Type 0: Not a Combination Product10/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35210/05/2015
    Labeler - Colorescience (128731929)

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