CITY BASE COMPACT FOUNDATION SPF 15- titanium dioxide paste

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS:

TITANIUM DIOXIDE 5.8%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

CITY BASE COMPACT FOUNDATION  SPF 15
titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-015-01	1 in 1 CARTON
1	NDC: 49527-015-02	14 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/1998

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
Len-Ron Manufacturing Division of Aramis Inc.		809771152	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc		042918826	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		949264774	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Bristol		959338336	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		943871157	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2		828534516	manufacture, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		205952385	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		244669714	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics, Ltd.		253616536	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Distribution Centre		208579636	repack, relabel

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder N.V.		370151326	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Whitman Laboratories Ltd.		216866277	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center (PALC)		078364654	repack, relabel