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THE TREATMENT POWDER FOUNDATION SPF 15

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 4.9g in 100g, OCTINOXATE 4.5g in 100g
Labeler: MAX HUBER RESEARCH LAB INC
NDC Code: 65966-111

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 INGREDIENTS: TITANIUM DIOXIDE, 4.9% [] OCTINOXATE 4.5%

INACTIVE INGREDIENTS: TALC [] DIMETHICONE [] SILICA [] BORON NITRIDE [] OCTYLDODECYL STEAROYL STEARATE [] NYLON-12 [] POLYMETHYL METHACRYLATE [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] POLYGLYCERYL-3 DIISOSTEARATE [] POLYPERFLUOROMETHYLISOPROPYL ETHER [] METHICONE [] MALACHITE [] TOURMALINE [] ZEOLITE [] CAPRYLYL GLYCOL [] ORYZANOL [] TOCOPHERYL ACETATE [] CALCIUM CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] HEXYLENE GLYCOL [] PHENOXYETHANOL [] SORBIC ACID []  [+/- MICA [] BISMUTH OXYCHLORIDE (CI 77163) [] TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)]

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

PRINCIPAL DISPLAY PANEL:


skin color de la mer

LA MER

the treatment powder foundation

spf 15



nt wt. 0.35 oz./10 g


MAX HUBER RESEARCH LABS INC DISTR.

NEW YORK, NY 10022


THE TREATMENT POWDER FOUNDATION  SPF 15
titanium dioxide, octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65966-111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE4.9 g  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE4.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC 
DIMETHICONE 
SILICON DIOXIDE 
BORON NITRIDE 
OCTYLDODECYL STEAROYL STEARATE 
YEAST 
CUPRIC CARBONATE 
CAPRYLYL GLYCOL 
GAMMA ORYZANOL 
ALPHA-TOCOPHEROL ACETATE 
CALCIUM CARBONATE 
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 
HEXYLENE GLYCOL 
PHENOXYETHANOL 
SORBIC ACID 
BISMUTH OXYCHLORIDE 
ZINC OXIDE 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
Packaging
#Item CodePackage Description
1NDC:65966-111-011 JAR (JAR) in 1 CARTON
1NDC:65966-111-0210 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2008
Labeler - MAX HUBER RESEARCH LAB INC (926708694)
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: 07/2011
 
MAX HUBER RESEARCH LAB 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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