DOUBLE WEAR STAY IN PLACE SPF 10 MAKEUP

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 4.0g in 100g
Labeler: ESTEE LAUDER INC
NDC Code: 11559-729

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 4.4%

INACTIVE INGREDIENTS: TALC [] ISOSTEARYL PALMITATE [] SILICA [] CALCIUM SILICATE [] BORON NITRIDE [] METHICONE [] TRIMETHYLSILOXYSILICATE [] PHENYL TRIMETHICONE [] POLYMETHYLSILSESQUIOXANE [] METHYL METHACRYLATE CROSSPOLYMER [] CAPRYLYL GLYCOL [] ADIPIC ACID/NEOPENTYL GLYCOL CROSSPOLYMER [] POLYPROPYLENE [] HEXYLENE GLYCOL [] PHENOXYETHANOL []  [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA [] CHROMIUM OXIDE GREENS (CI 77288) [] CHROMIUM HYDROXIDE GREEN (CI 77289) [] CARMINE (CI 75470) [] BISMUTH OXYCHLORIDE (CI 77163) [] TITANIUM DIOXIDE (CI 77891)]

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

ESTEE LAUDER


DOUBLE WEAR

STAY-IN-PLACE POWDER MAKEUP

SPF 10





NET WT. 0.42 OZ/ 12 g



Estee Lauder Dist.
New York, NY 10022






DOUBLE WEAR  STAY IN PLACE SPF 10 MAKEUP
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-729
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE4.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC 
SILICON DIOXIDE 
CALCIUM SILICATE 
BORON NITRIDE 
PHENYL TRIMETHICONE 
POLYMETHYLSILSESQUIOXANE (11 MICRONS) 
CAPRYLYL GLYCOL 
ALUMINUM HYDROXIDE 
HEXYLENE GLYCOL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
MICA 
CHROMIC OXIDE 
COCHINEAL 
BISMUTH OXYCHLORIDE 
Packaging
#Item CodePackage Description
1NDC:11559-729-011 JAR (JAR) in 1 CARTON
1NDC:11559-729-0212 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2007
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 10/2011
 
ESTEE LAUDER INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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