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.

----------

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-727
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
TALC (UNII: 7SEV7J4R1U)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ZINC STEARATE (UNII: H92E6QA4FV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
MICA (UNII: V8A1AW0880)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FERRIC FERROCYANIDE (UNII: TLE294X33A)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
COCHINEAL (UNII: TZ8Z31B35M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-727-011 in 1 CARTON
1NDC:11559-727-0215 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2010
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture

Revised: 6/2011
Document Id: 03f45157-ff4a-41c9-9e29-c932aaeac539
Set id: bd1b687b-6062-4a0d-9d3c-dc7ea63f3a42
Version: 1
Effective Time: 20110627
 
ESTEE LAUDER INC