NDC Code(s) : 13733-221-01, 13733-222-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA Signature Volume Brightening Concealer SPF30 No21Titanium Dioxide, Octinoxate, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-221
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 DIOXIDE13.2 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE4 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.98 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HIBISCUS SABDARIFFA FLOWER(UNII: 45TGG6IU6M)
SODIUM PALMITOYL PROLINE(UNII: 64L053FRFO)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
METHYLPROPANEDIOL(UNII: N8F53B3R4R)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
MICA(UNII: V8A1AW0880)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
NIACINAMIDE(UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
GLYCERYL BEHENATE/EICOSADIOATE(UNII: 73CJJ317SR)
STEARIC ACID(UNII: 4ELV7Z65AP)
LAVENDER OIL(UNII: ZBP1YXW0H8)
ROSEMARY OIL(UNII: 8LGU7VM393)
CHAMAEMELUM NOBILE FLOWER OIL(UNII: UB27587839)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
HIPPOPHAE RHAMNOIDES FRUIT(UNII: AVL0R9111T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ADENOSINE(UNII: K72T3FS567)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
HORSE CHESTNUT(UNII: 3C18L6RJAZ)
ALCOHOL(UNII: 3K9958V90M)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
NYMPHAEA ALBA FLOWER(UNII: 40KQ7Q535O)
BENZYL ALCOHOL(UNII: LKG8494WBH)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
DEHYDROACETIC ACID(UNII: 2KAG279R6R)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-221-013 g in 1 APPLICATOR Type 0: Not a Combination Product08/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/01/2016
MISSHA Signature Volume Brightening Concealer SPF30 No23Titanium Dioxide, Octinoxate, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-222
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 DIOXIDE13.2 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE4 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.98 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HIBISCUS SABDARIFFA FLOWER(UNII: 45TGG6IU6M)
SODIUM PALMITOYL PROLINE(UNII: 64L053FRFO)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
METHYLPROPANEDIOL(UNII: N8F53B3R4R)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
MICA(UNII: V8A1AW0880)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
NIACINAMIDE(UNII: 25X51I8RD4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
GLYCERYL BEHENATE/EICOSADIOATE(UNII: 73CJJ317SR)
STEARIC ACID(UNII: 4ELV7Z65AP)
LAVENDER OIL(UNII: ZBP1YXW0H8)
ROSEMARY OIL(UNII: 8LGU7VM393)
CHAMAEMELUM NOBILE FLOWER OIL(UNII: UB27587839)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
HIPPOPHAE RHAMNOIDES FRUIT(UNII: AVL0R9111T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ADENOSINE(UNII: K72T3FS567)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
HORSE CHESTNUT(UNII: 3C18L6RJAZ)
ALCOHOL(UNII: 3K9958V90M)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
NYMPHAEA ALBA FLOWER(UNII: 40KQ7Q535O)
BENZYL ALCOHOL(UNII: LKG8494WBH)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
DEHYDROACETIC ACID(UNII: 2KAG279R6R)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-222-013 g in 1 APPLICATOR Type 0: Not a Combination Product08/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/01/2016

PRINCIPAL DISPLAY PANEL

MisshaSignatureVolumeBrighteningConcealer21

PRINCIPAL DISPLAY PANEL

MisshaSignatureVolumeBrighteningConcealer23