UV DEFENSE FLUID- titanium dioxide and zinc oxide cream 
H2O Plus

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.

----------

UV Defense Fluid

Drug Facts

Active ingredientPurpose
Zinc Oxide 14%Sunscreen
Titanium Dioxide 11%Sunscreen

Uses

Warnings

  • 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

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

Questions or comments?

1-800-242-2284

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
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)

Revised: 4/2014
Document Id: 8b291140-d4a3-4952-a404-1c0b008e3b2b
Set id: 7062d96c-3b39-4d21-a2ae-7a8d9df3c96a
Version: 1
Effective Time: 20140414
 
H2O Plus