Medication Guide App

SUPERBALANCED MAKEUP SPF 15 MINERAL RICH FORMULA

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 6.3g in 100g
Labeler: CLINIQUE LABORATORIES INC.
NDC Code: 49527-746

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 6.30%

inactive ingredients: talc [] mica [] octyldodecyl stearoyl stearate [] zinc stearate [] zinc laurate [] dimethicone [] bentonite [] hdi/trimethylol hexyllactone crosspolymer [] silica [] hydrolyzed soy protein [] glycerin [] lauroyl lysine [] astrocaryum murumuru seed butter [] squalane [] cetearyl dimethicone crosspolymer [] lecithin [] triethoxycaprylylsilane [] tocopheryl acetate [] tetrahexyldecyl ascorbate [] magnesium myristate [] coconut acid [] water\aqua\eau [] tetrasodium edta [] chlorphenesin [] potassium sorbate []  [+/- titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499) [] bismuth oxychloride (ci 77163)

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

clinique

superbalanced powder makeup
spf 15

mineral-rich formula




net wt. 0.63 oz/ 18g


clinique laboratories distr.
new york, ny 10022

SUPERBALANCED  MAKEUP SPF 15 MINERAL RICH FORMULA
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-746
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE6.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
OCTYLDODECYL STEAROYL STEARATE 
ZINC STEARATE 
ZINC LAURATE 
DIMETHICONE 
BENTONITE 
SILICON DIOXIDE 
GLYCERIN 
LAUROYL LYSINE 
ASTROCARYUM MURUMURU SEED BUTTER 
SQUALANE 
LECITHIN, SOYBEAN 
TRIETHOXYCAPRYLYLSILANE 
ALPHA-TOCOPHEROL ACETATE 
TETRAHEXYLDECYL ASCORBATE 
MAGNESIUM MYRISTATE 
COCONUT ACID 
WATER 
EDETATE SODIUM 
CHLORPHENESIN 
POTASSIUM SORBATE 
FERRIC OXIDE RED 
BISMUTH OXYCHLORIDE 
Packaging
#Item CodePackage Description
1NDC:49527-746-011 JAR (JAR) in 1 CARTON
1NDC:49527-746-0218 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2010
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

Revised: 09/2011
 
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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