NDC Code(s) : 13733-194-01, 13733-195-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA SIGNATURE ESSENCE CUSHION INTENSIVE COVER SPF50 NO 21Titanium Dioxide, Octinoxate, Octisalate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-194
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.7921 g in 14 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.938 g in 14 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE0.56 g in 14 g
Inactive Ingredients
Ingredient Name Strength
DIPHENYL DIMETHICONE (100 CST)(UNII: AG1ANB6B8O)
CALCIUM CARBONATE(UNII: H0G9379FGK)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
METHYL METHACRYLATE(UNII: 196OC77688)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
RICE GERM OIL(UNII: D4H5GGS5JF)
ALUMINUM OXIDE(UNII: LMI26O6933)
RICE BRAN OIL(UNII: LZO6K1506A)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
MICA(UNII: V8A1AW0880)
TRISILOXANE(UNII: 9G1ZW13R0G)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
HONEY(UNII: Y9H1V576FH)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
STEARIC ACID(UNII: 4ELV7Z65AP)
ADENOSINE(UNII: K72T3FS567)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOBACILLUS REUTERI(UNII: 9913I24QEE)
PANAX GINSENG ROOT WATER(UNII: P9T4K47OM0)
GLYCERIN(UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
NIACINAMIDE(UNII: 25X51I8RD4)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-194-0114 g in 1 CARTON Type 0: Not a Combination Product06/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2016
MISSHA SIGNATURE ESSENCE CUSHION INTENSIVE COVER SPF50 NO 23Titanium Dioxide, Octinoxate, Octisalate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-195
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.7921 g in 14 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.938 g in 14 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE0.56 g in 14 g
Inactive Ingredients
Ingredient Name Strength
PENTYLENE GLYCOL(UNII: 50C1307PZG)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
STEARIC ACID(UNII: 4ELV7Z65AP)
ADENOSINE(UNII: K72T3FS567)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOBACILLUS REUTERI(UNII: 9913I24QEE)
PANAX GINSENG ROOT WATER(UNII: P9T4K47OM0)
GLYCERIN(UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
NIACINAMIDE(UNII: 25X51I8RD4)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
TRISILOXANE(UNII: 9G1ZW13R0G)
DIPHENYL DIMETHICONE (100 CST)(UNII: AG1ANB6B8O)
CALCIUM CARBONATE(UNII: H0G9379FGK)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
METHYL METHACRYLATE(UNII: 196OC77688)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
RICE GERM OIL(UNII: D4H5GGS5JF)
ALUMINUM OXIDE(UNII: LMI26O6933)
RICE BRAN OIL(UNII: LZO6K1506A)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
MICA(UNII: V8A1AW0880)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
HONEY(UNII: Y9H1V576FH)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-195-0114 g in 1 CARTON Type 0: Not a Combination Product06/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2016

PRINCIPAL DISPLAY PANEL

SignatureEssenceCushionIntensiveCover21

PRINCIPAL DISPLAY PANEL

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