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Name:Nutritiousvita Mineral Loose Powder Makeup Spf 15
Manufacturer:Estee Lauder Inc
Category:Over-the-counter (OTC) Marketed Drugs


NUTRITIOUS VITA MINERAL LOOSE POWDER MAKEUP SPF 15 - titanium dioxide powder 
ESTEE LAUDER INC

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.

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ACTIVE INGREDIENT: TITANIUM DIOXIDE 2.10%

INACTIVE INGREDIENTS: TALC [] POLYMETHYLSILSESQUIOXANE [] HYDROGENATED POLYDECENE [] BORON NITRIDE [] CALCIUM ALUMINUM BOROSILICATE [] METHICONE [] TRIETHOXYCAPRYLYLSILANE [] MAGNESIUM MYRISTATE [] PHYTOSTEROLS [] TETRAHEXYLDECYL ASCORBATE [] ZEOLITE [] CAPRYLYL GLYCOL [] CALCIUM SILICATE [] HYDROGENATED STYRENE/ ISOPRENE COPOLYMER [] SODIUM CHLORIDE [] TOCOPHERYL ACETATE [] LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER [] HEXYLENE GLYCOL [] ZINC STEARATE [] SILICA [] POTASSIUM SORBATE [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] BISMUTH OXYCHLORIDE (CI 77163) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA [] YELLOW 5 LAKE (CI 19140) [] FERRIC FERROCYANIDE (CI 77510) [] BLUE 1 LAKE (CI 42090) [] CHROMIUM OXIDE GREENS (CI 77288) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] CARMINE (CI 75470)]

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

ESTEE LAUDER

NUTRITIOUS

VITA-MINERAL LOOSE POWDER

MAKEUP

SPF 15



NT WT 0.52 OZ/15 g



DISTR ESTEE LAUDER INC

NEW YORK, NY 10022

FOLDING CARTON


NUTRITIOUS  VITA MINERAL LOOSE POWDER MAKEUP SPF 15
titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-727
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED POLYDECENE (550 MW)  
TALC  
POLYMETHYLSILSESQUIOXANE (11 MICRONS)  
BORON NITRIDE  
DIMETHICONE  
TRIETHOXYCAPRYLYLSILANE  
MAGNESIUM MYRISTATE  
TETRAHEXYLDECYL ASCORBATE  
CAPRYLYL GLYCOL  
CALCIUM SILICATE  
SODIUM CHLORIDE  
ALPHA-TOCOPHEROL ACETATE  
HEXYLENE GLYCOL  
ZINC STEARATE  
SILICON DIOXIDE  
POTASSIUM SORBATE  
PHENOXYETHANOL  
FERRIC OXIDE RED  
BISMUTH OXYCHLORIDE  
MICA  
FD&C YELLOW NO. 5  
FERRIC FERROCYANIDE  
FD&C BLUE NO. 1  
CHROMIC OXIDE  
COCHINEAL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11559-727-01 1 JAR ( JAR) in 1 CARTON contains a JAR (11559-727-02)
1 NDC:11559-727-02 15 g in 1 JAR This package is contained within the CARTON (11559-727-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/01/2010

Labeler - ESTEE LAUDER INC (005914387)
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER COSMETICS, LTD 205952385 manufacture
Establishment
Name Address ID/FEI Operations
ESTEE LAUDER N.V. 370151326 manufacture
Establishment
Name Address ID/FEI Operations
Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture
Establishment
Name Address ID/FEI Operations
Aramis Inc. 042918826 manufacture
Establishment
Name Address ID/FEI Operations
Northtec Bristol 949264774 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Northtec Keystone 618107429 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd. 255175580 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics, Ltd 253616536 manufacture
Establishment
Name Address ID/FEI Operations
Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel
Establishment
Name Address ID/FEI Operations
Estee Lauder Kabushiki Kaisha 712808195 relabel, repack
Establishment
Name Address ID/FEI Operations
Whitman Laboratories Ltd. 216866277 manufacture
Establishment
Name Address ID/FEI Operations
Aveda Corporation 071352058 manufacture

Revised: 06/2011 ESTEE LAUDER INC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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