NDC Code(s) : 37000-080-30, 37000-080-15, 37000-080-01, 37000-080-19
Packager : The Procter & Gamble Manufacturing Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dolce and Gabbana The Foundation Perfect Matte Ensulizole LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37000-080
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE(UNII: 9YQ9DI1W42)
(ENSULIZOLE - UNII:9YQ9DI1W42) 		ENSULIZOLE30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TALC(UNII: 7SEV7J4R1U)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
BENZYL ALCOHOL(UNII: LKG8494WBH)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ARACHIDYL BEHENATE(UNII: 9G00Q0O2NS)
TRIHYDROXYSTEARIN(UNII: 06YD7896S3)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BENZOATE(UNII: OJ245FE5EU)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
ISOPROPYL TITANIUM TRIISOSTEARATE(UNII: 949E3KBJ1I)
ETHYLENE BRASSYLATE(UNII: 9A87HC7ROD)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-080-301 in 1 CARTON 10/01/2012
130 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product
2NDC:37000-080-1515 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product10/01/2012
3NDC:37000-080-011.5 mL in 1 POUCH Type 0: Not a Combination Product10/01/2012
4NDC:37000-080-191 in 1 CARTON 10/01/2012
41.9 mL in 1 JAR Type 0: Not a Combination Product10/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/01/2012 03/23/2019

PRINCIPAL DISPLAY PANEL

DOLCE & GABBANA

THE FOUNDATION

PERFECT
MATTE LIQUID
FOUNDATION
WITH ENSULIZOLE
SUNSCREEN

BROAD SPECTRUM SPF 20

30 ml / 1 FL. OZ.

Principal Display Panel - 30 ml Bottle Carton