Label: UV DEFENSE FLUID- titanium dioxide and zinc oxide cream

  • 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 April 14, 2014

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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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