NDC Code(s) : 13733-313-01
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 SPF50 NO31Titanium Dioxide, Octinoxate, Octisalate LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-313
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE0.04 g in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.093 g in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.067 g in 1 g
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
BORON NITRIDE(UNII: 2U4T60A6YD)
AVOCADO OIL(UNII: 6VNO72PFC1)
XYLITOL(UNII: VCQ006KQ1E)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
SUNFLOWER OIL(UNII: 3W1JG795YI)
BAMBUSA VULGARIS TOP(UNII: FIW80T6P6V)
HAMAMELIS VIRGINIANA TOP(UNII: UDA30A2JJY)
ADANSONIA DIGITATA FRUIT(UNII: 51N9TR1W6P)
OXYGEN(UNII: S88TT14065)
NIACINAMIDE(UNII: 25X51I8RD4)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
STEARIC ACID(UNII: 4ELV7Z65AP)
ALUMINUM OXIDE(UNII: LMI26O6933)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
TAMANU OIL(UNII: JT3LVK84A1)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
DIMETHICONE(UNII: 92RU3N3Y1O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYL METHACRYLATE(UNII: 196OC77688)
ADENOSINE(UNII: K72T3FS567)
WATER(UNII: 059QF0KO0R)
PEG-9 DIMETHICONE(UNII: 9OZ27X065D)
TOCOPHEROL(UNII: R0ZB2556P8)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
GLYCERIN(UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ROSA CANINA FRUIT OIL(UNII: CR7307M3QZ)
OLIVE OIL(UNII: 6UYK2W1W1E)
SELENICEREUS GRANDIFLORUS FLOWER(UNII: II877K4UNR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-313-0115 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

MISSHAMMAGICCUSHIONCOVERN031