UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]

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  • UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]

UV DEFENSE FLUID (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [H2O PLUS]
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NDC 65903-171-01
Set ID 7062d96c-3b39-4d21-a2ae-7a8d9df3c96a
Category HUMAN OTC DRUG LABEL
Packager H2O Plus
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Zinc Oxide 14%Sunscreen
    Titanium Dioxide 11%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

    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if skin rash occurs

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • apply generously and evenly 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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, Aqua/Water/Eau, Dimethicone, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Dipropylene Glycol, Isodecyl Isononanoate, Alumina, Stearic Acid, C12-15 Alkyl Benzoate, Sodium Chloride, Aspalathus Linearis Extract, Camellia Sinensis Leaf Extract, Phyllanthus Emblica Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Undaria Pinnatifida Extract, Tocopherol, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Ferulic Acid, Glycerin, Glyceryl Polyacrylate, Hydrogen Dimethicone, Hydrolyzed Pearl, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Maltodextrin, PEG/PPG18/18 Dimethicone, Propylene Glycol, Sodium Citrate, Sodium Hyaluronate, Tetrahydrodiferuloylmethane, Phenoxyethanol, Potassium Sorbate, Sorbic Acid, Parfum/ Fragrance, Benzyl Salicylate, Hexyl Cinnamal, Limonene, Linalool, CI 77491/ Iron Oxides, CI 77492/Iron Oxides (090-20171-000)

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Questions or comments?

    1-800-242-2284

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    H2O Plus, L.L.C.
    Chicago, IL 60607

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    h2o+™

    total SOURCE™

    Advanced age repair

    UV DEFENSE FLUID
    SPF 50 PA+++

    30 mL / 1 U.S. Fl oz e

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    UV DEFENSE FLUID 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-171
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide11 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide14 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Oxide (UNII: LMI26O6933)  
    Water (UNII: 059QF0KO0R)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Hard Particle) (UNII: H895X08VNQ)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Dipropylene Glycol (UNII: E107L85C40)  
    Ferulic Acid (UNII: AVM951ZWST)  
    Glycerin (UNII: PDC6A3C0OX)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Isodecyl Isononanoate (UNII: 4X46Q4U00Z)  
    Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Phyllanthus Emblica Fruit (UNII: YLX4CW2576)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Rosemary (UNII: IJ67X351P9)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sorbic Acid (UNII: X045WJ989B)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Tetrahydrodiferuloylmethane (UNII: 00U0645U03)  
    Tocopherol (UNII: R0ZB2556P8)  
    Undaria Pinnatifida (UNII: ICV1OK7M1S)  
    Benzyl Benzoate (UNII: N863NB338G)  
    .Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)  
    Limonene, (-)- (UNII: 47MAJ1Y2NE)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65903-171-0130 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/01/2014
    Labeler - H2O Plus (807722947)
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