NDC Code(s) : 13733-225-01, 13733-226-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA The Style Fitting Wear Foundation SPF30 No21Titanium Dioxide, Octinoxate, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-225
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.04 g in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.109 g in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.01 g in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYL METHACRYLATE(UNII: 196OC77688)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ADENOSINE(UNII: K72T3FS567)
BORON NITRIDE(UNII: 2U4T60A6YD)
CENTAUREA CYANUS FLOWER(UNII: QZ239038YC)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DIMETHICONE(UNII: 92RU3N3Y1O)
NIACINAMIDE(UNII: 25X51I8RD4)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
COCONUT ACID(UNII: 40U37V505D)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
WATER(UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP(UNII: UDA30A2JJY)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
HONEY(UNII: Y9H1V576FH)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
SAMBUCUS NIGRA FLOWER(UNII: 07V4DX094T)
LACTOBACILLUS REUTERI(UNII: 9913I24QEE)
ALCEA ROSEA FLOWER(UNII: 1250O8MKPZ)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-225-0130 g in 1 CARTON Type 0: Not a Combination Product21/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/21/2016
MISSHA The Style Fitting Wear Foundation SPF30 No23Titanium Dioxide, Octinoxate, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-226
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 DIOXIDE0.109 g in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.04 g in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.01 g in 1 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
HONEY(UNII: Y9H1V576FH)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
SAMBUCUS NIGRA FLOWER(UNII: 07V4DX094T)
LACTOBACILLUS REUTERI(UNII: 9913I24QEE)
ALCEA ROSEA FLOWER(UNII: 1250O8MKPZ)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
METHYL METHACRYLATE(UNII: 196OC77688)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ADENOSINE(UNII: K72T3FS567)
BORON NITRIDE(UNII: 2U4T60A6YD)
CENTAUREA CYANUS FLOWER(UNII: QZ239038YC)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DIMETHICONE(UNII: 92RU3N3Y1O)
NIACINAMIDE(UNII: 25X51I8RD4)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
COCONUT ACID(UNII: 40U37V505D)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
WATER(UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP(UNII: UDA30A2JJY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-226-0130 g in 1 CARTON Type 0: Not a Combination Product21/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/21/2016

PRINCIPAL DISPLAY PANEL

MissahTheStyleFittingWearFoundationNo21

PRINCIPAL DISPLAY PANEL

MisshaTheStyleFittingWearFoundationNo23