DOUBLE WEAR MINERAL RICH LOOSE POWDER MAKEUP SPF 12- 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 2.2%

INACTIVE INGREDIENTS: TALC [] ZINC STEARATE [] CAPRYLYL METHICONE [] OCTYLDODECYL STEAROYL STEARATE [] BIS-HYDROXYETHOXYPROPYL DIMETHICONE/IPDI COPOLYMER ETHYLCARBAMTE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] DEHYDROACETIC ACID []  [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] ZINC OXIDE (CI 77947) [] TITANIUM DIOXIDE (CI 77891) [] YELLOW 5 LAKE (CI 19140) [] CHROMIUM OXIDE GREENS (CI 77288) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] FERRIC FERROCYANIDE (CI 77510) [] CARMINE (CI 75470) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090)]

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

PRINCIPAL DISPLAY PANEL:



ESTEE LAUDER

DOUBLE WEAR

MINERAL RICH LOOSE POWDER MAKEUP

SPF 12



NT WT 0.39 OZ/ 11 g



ESTEE LAUDER DIST

NEW YORK, NY 10022

FOLDING CARTON



DOUBLE WEAR  MINERAL RICH LOOSE POWDER MAKEUP SPF 12
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
MICA (UNII: V8A1AW0880)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
COCHINEAL (UNII: TZ8Z31B35M)  
FERRIC FERROCYANIDE (UNII: TLE294X33A)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-014-011 in 1 CARTON
1NDC:11559-014-0211 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2010
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
INTERCOS071352058manufacture

Revised: 11/2011
Document Id: b1fe154e-ce61-4912-a867-3cb86894ff4e
Set id: dbc5bf8f-711d-4455-be2e-65ca63720e75
Version: 1
Effective Time: 20111111
 
ESTEE LAUDER INC