CITY BASE COMPACT FOUNDATION SPF 15

Dosage form: paste
Ingredients: TITANIUM DIOXIDE 5.8g in 100g
Labeler: CLINIQUE LABORATORIES INC.
NDC Code: 49527-015

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.

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




CITY BASE COMPACT FOUNDATION  SPF 15
titanium dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE5.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE 
COCO-CAPRYLATE/CAPRATE 
DIMETHICONE 
HIGH DENSITY POLYETHYLENE 
CARNAUBA WAX 
CETYL RICINOLEATE 
BARIUM SULFATE 
HYDROGENATED COCO-GLYCERIDES 
TRIBEHENIN 
ALUMINUM STARCH OCTENYLSUCCINATE 
CANDELILLA WAX 
MAGNESIUM MYRISTATE 
BUTYLATED HYDROXYTOLUENE 
MICA 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
Packaging
#Item CodePackage Description
1NDC:49527-015-011 JAR (JAR) 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/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Keystone949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Bristol959338336manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone943871157manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Ltd.205952385manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.244669714manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Centre208579636repack, relabel
Establishment
NameAddressID/FEIOperations
ELGC K.K.712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center (PALC)078364654repack, relabel

Revised: 06/2012
 
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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