ALMOST POWDER MAKEUP SPF 15

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 13.0g in 100g, OCTINOXATE 2.0g in 100g
Labeler: CLINIQUE LABORATORIES INC
NDC Code: 49527-800

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 13.00% [] octinoxate 2.00%

inactive ingredients: talc [] dimethicone [] nylon-12 [] silica [] squalane [] boron nitride [] vinyl dimethicone/methicone silsesquioxane crosspolymer [] cetyl caprylate [] diisostearyl malate [] phytosteryl/isostearyl/cetyl/stearyl/behenyl  dimer dilinoleate [] methicone [] aluminum hydroxide [] glycerin [] sodium hyaluronate [] magnesium palmitoyl glutamate [] sodium palmitoyl sarcosinate [] palmitoyl proline [] alumina [] tocopherol [] palmitic acid [] 1,2-hexanediol [] ascorbyl tetraisopalmitate [] tin oxide [] sodium dehydroacetate []  [+/- iron oxides (ci 77499, ci 77492, ci 77491) [] mica [] titanium dioxide (ci 77891)]

warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children.

principal display panel:



CLINIQUE

ALMOST POWDER MAKEUP

SPF 15



NT WT. 0.35 OZ/ 10 g


clinique laboratories dist.
new york, ny 10022



ALMOST POWDER MAKEUP  SPF 15
titanium dioxide, octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-800
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE13.0 g  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC 
DIMETHICONE 
SILICON DIOXIDE 
SQUALANE 
BORON NITRIDE 
CETYL OCTANOATE 
ALUMINUM HYDROXIDE 
GLYCERIN 
HYALURONATE SODIUM 
SODIUM PALMITOYL GLUTAMATE 
ALUMINUM OXIDE 
TOCOPHEROL 
PALMITIC ACID 
HEXANEDIOL 
ASCORBYL PALMITATE 
TIN 
SODIUM DEHYDROACETATE 
FERRIC OXIDE RED 
MICA 
Packaging
#Item CodePackage Description
1NDC:49527-800-011 JAR (JAR) in 1 CELLO PACK
1NDC:49527-800-0210 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2007
Labeler - CLINIQUE LABORATORIES INC (173047747)
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
Establishment
NameAddressID/FEIOperations
ASANUMA CORP LTD700717762manufacture

Revised: 06/2011
 
CLINIQUE LABORATORIES 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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