NDC Code(s) : 13733-191-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA M Magic Cushion Moisture No23Titanium Dioxide, Octinoxate, Octisalate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-191
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 DIOXIDE1.4775 g in 15 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.005 g in 15 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE0.6 g in 15 g
Inactive Ingredients
Ingredient Name Strength
PENTYLENE GLYCOL(UNII: 50C1307PZG)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER(UNII: EG97988M5Q)
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)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
STEARIC ACID(UNII: 4ELV7Z65AP)
ADENOSINE(UNII: K72T3FS567)
MAGNESIUM DISODIUM EDTA(UNII: NDT563S5VZ)
YEAST(UNII: 3NY3SM6B8U)
ROSA DAMASCENA FLOWER(UNII: JWB78P295A)
CENTAUREA CYANUS FLOWER(UNII: QZ239038YC)
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS(UNII: 358X17CAT0)
SAFFLOWER SEED(UNII: 8FCL6A31TX)
EVENING PRIMROSE OIL(UNII: 3Q9L08K71N)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LACTOBACILLUS REUTERI(UNII: 9913I24QEE)
PANAX GINSENG ROOT WATER(UNII: P9T4K47OM0)
WATER(UNII: 059QF0KO0R)
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)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
TRISILOXANE(UNII: 9G1ZW13R0G)
DIPHENYL DIMETHICONE (100 CST)(UNII: AG1ANB6B8O)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER(UNII: 7K68DGG29P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-191-0115 g in 1 CARTON Type 0: Not a Combination Product22/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/22/2016

PRINCIPAL DISPLAY PANEL

MMagicCushionMoistureNo23R