SUPERBALANCED MAKEUP SPF 15 MINERAL RICH FORMULA- titanium dioxide powder 
CLINIQUE LABORATORIES 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 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

folding carton

SUPERBALANCED  MAKEUP SPF 15 MINERAL RICH FORMULA
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-746
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
MICA (UNII: V8A1AW0880)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
ZINC STEARATE (UNII: H92E6QA4FV)  
ZINC LAURATE (UNII: 4YOP58Y695)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BENTONITE (UNII: A3N5ZCN45C)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAUROYL LYSINE (UNII: 113171Q70B)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
SQUALANE (UNII: GW89575KF9)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
COCONUT ACID (UNII: 40U37V505D)  
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-746-011 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/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
Aveda Corporation071352058manufacture

Revised: 9/2011
Document Id: 2d8f51b5-b51b-47f3-b07d-de1345ea4990
Set id: b5ef5f9d-ef4f-4406-8f6e-b10e14ab6499
Version: 1
Effective Time: 20110913
 
CLINIQUE LABORATORIES INC.