DERMAQUEST TM SKIN THERAPY, BREATHABLE COVERAGE TM MINERAL FOUNDATION SPF-30, DERMAMINERALS TM  - titanium dioxide and zinc oxide cream 
Allure Cosmetic, Inc.

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Drug Facts

ACTIVE INGREDIENTS: Titanium Dioxide 4.8%, Zinc Oxide 5.8%

INACTIVE INGREDIENTS: Cyclopentasiloxane , Dimethicone, Dimethicone PEG-10/15 Crosspolymer, Water(Aqua), Vinyl Dimethicone Crosspolymer, Cyclomethicone, PEG/PPG-18/18 Dimethicone, Perfluorodecalin, Hydrolyzed Ceratonai Siliqua Seed Extract, Phopspholipids, Saccgaromyces Lysate Extract, Sodium PCA, PPG-12/SMDI Copolymer, Magnesium Silicate, Nylon-12, Tocopheryl Acetate, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Hordeum Distichon (Barley ) Extract, Sodium Hyaluronate, Saccaromyces, Xylinium Black Tea Ferment, Glycerin, Hydroxyethylcellulose, Algae Extract, Artemesia Vulgaris Extract, Centella Asiatica Extract, Cetearyl Olivate, Sorbitan Olivate, Tetrahxyldecyl Ascorbate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Hexyl Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Stearic Acid, Aluminum Hydroxide, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl laurate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Aloe Barbedensis Leaf Juice Powder.

[+/- (May Contain) Iron Oxides (Cl77499, Cl 77491, Cl77492), Titanium Dioxide (Cl 77891)]

Labeling Information on the Carton

1. Principal Display Panel: Principal Display Panel  is shown in the image below.
   
2. Back Panel: Active Ingredients (Titanium Dioxide 4.8%, Zinc Oxide 5.8%), Inactive Ingredients (as listed above) are listed on the white back panel of the carton. Directions: Apply with a foundation brush for flawless coverage. Discontinue usage if irritation develops.
   
3. Side Panel A: "DermaMinerals TM " is printed in white on purplish background on one of the side panels.
4. Side Panel B: The other side panel has the use information : Protect from harmful UVA and UVB rays while creating the perfect canvas with our mineral-based SPF 30 liquid foundation. Other label claims:
   
   Paraben-Free
   
   Talc-Free
   
   Synthetic
   Dye-Free
   
   Bismuth Oxychloride-Free
   
   Oil-Free
   
   Very Water
   Resistant            
   
   
   Manufactured for
   DermaQuest TM, Inc.
   
   Hayward
   CA, 94544
   dermaquestinc.com
   
   Made in USA
   
5. Top lid of the carton is blank.
6. Bottom of the carton Lot#, Exp Date, and UPC
   

  

DERMAQUEST TM SKIN THERAPY, BREATHABLE COVERAGE TM MINERAL FOUNDATION SPF-30, DERMAMINERALS TM  zinc oxide and titanium dioxide   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 62742-4030 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (Titanium) TITANIUM DIOXIDE 48 mg  in 1 mL ZINC OXIDE (ZINC CATION) ZINC OXIDE 58 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Dimethicone   Water   Cyclomethicone   HYALURONATE SODIUM   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   Stearic Acid   Aluminum Hydroxide   Hexyl Laurate   Phenoxyethanol   Hexylene Glycol   GLYCERIN   CYCLOMETHICONE 5   SODIUM PYRROLIDONE CARBOXYLATE   CYCLOMETHICONE 5   SODIUM PYRROLIDONE CARBOXYLATE   MAGNESIUM TRISILICATE   .ALPHA.-TOCOPHEROL ACETATE, D-

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 62742-4030-2 1 TUBE In 1 CARTON contains a TUBE (62742-4030-1) 1 62742-4030-1 30 mL In 1 TUBE This package is contained within the CARTON (62742-4030-2)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2009

Labeler - Allure Cosmetic, Inc. (926831603)

Registrant - Allure Cosmetic, Inc. (926831603)

Establishment
Name	Address	ID/FEI	Operations
Allure Cosmetic, Inc.		926831603	manufacture

Revised: 01/2010Allure Cosmetic, Inc.