CITY BASE COMPACT FOUNDATION SPF 15- titanium dioxide paste 
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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DRUG FACTS

ACTIVE INGREDIENTS:

TITANIUM DIOXIDE 5.8%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

WARNINGS

FOR EXTERNAL USE ONLY

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

For sunscreen use:

    * apply liberally 15 minutes before sun exposure
    * reapply at least every two hours
    * use a water resistant sunscreen if swimming or sweating
    * Sun Protection Measures.
      Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
          o limit time in the sun, especially from 10 a.m.–2 p.m.
          o wear long-sleeved shirts, pants, hats and sunglasses
    * children under 6 months of age: ask a doctor

INACTIVE INGREDIENTS

ingredients: propylene glycol dicaprylate/dicaprate [] nylon-12 [] coco-caprylate/caprate [] dimethicone [] polyethylene [] copernicia cerifera (carnauba) wax\cera carnauba\cire de carnauba [] cetyl ricinoleate [] polysilicone-11 [] barium sulfate [] hydrogenated coco-glycerides [] tribehenin [] aluminum starch octenylsuccinate [] euphorbia cerifera (candelilla) wax\candelilla cera\cire de candelilla [] magnesium myristate [] bht []  [+/- mica [] iron oxides (ci 77491, ci 77492, ci 77499) [] titanium dioxide (ci 77891)]

OTHER INFORMATION

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL:


CLINIQUE

CITY BASE

COMPACT FOUNDATION

BROAD SPECTRUM

SPF 15



POIDS NT. WT.0.5 OZ/ 14 g



CLINIQUE LABORATORIES INC DIST
NY NY 10022

folding carton



CITY BASE COMPACT FOUNDATION  SPF 15
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CETYL RICINOLEATE (UNII: 1P677500YD)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
CANDELILLA WAX (UNII: WL0328HX19)  
MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49527-015-011 in 1 CARTON
1NDC:49527-015-0214 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/1998
Labeler - CLINIQUE LABORATORIES INC. (173047747)
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Bristol959338336manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone943871157manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.244669714manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Centre208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center (PALC)078364654repack, relabel

Revised: 6/2012
Document Id: b0611de3-4a29-4f8c-ae39-d9a383bb15df
Set id: 7f1515dd-56c6-4d8b-bc28-dc65ff90e98f
Version: 1
Effective Time: 20120619
 
CLINIQUE LABORATORIES INC.