UV DEFENSE FLUID- titanium dioxide and zinc oxide cream

UV Defense Fluid by

Drug Labeling and Warnings

UV Defense Fluid by is a Otc medication manufactured, distributed, or labeled by H2O Plus. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient	Purpose
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

INGREDIENTS AND APPEARANCE

UV DEFENSE FLUID 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65903-171
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	11 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65903-171-01	30 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/01/2014

Labeler - H2O Plus (807722947)