NDC Code(s) : 13733-406-01, 13733-403-01, 13733-404-01, 13733-405-01
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 - Covering (No.23)Titanium Dioxide, Octinoxate, Octisalate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-406
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 DIOXIDE2.122392563 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
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
NIACINAMIDE(UNII: 25X51I8RD4)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER(UNII: EG97988M5Q)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ADENOSINE(UNII: K72T3FS567)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
16-METHYLHEPTADECANOIC ACID(UNII: LZM5XA0ILL)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-406-0115 g in 1 CARTON Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/18/2018
MISSHA Signature Essence Cushion - Watering(No.21)Titanium Dioxide, Octinoxate, Octisalate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-403
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 DIOXIDE1.3146705 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
DIMETHICONE(UNII: 92RU3N3Y1O)
ADENOSINE(UNII: K72T3FS567)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
NIACINAMIDE(UNII: 25X51I8RD4)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ALCOHOL(UNII: 3K9958V90M)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
POLYMETHYLSILSESQUIOXANE (11 MICRONS)(UNII: Z570VEV8XK)
ISODODECANE(UNII: A8289P68Y2)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS(UNII: D818OLQ51Z)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-403-0115 g in 1 CARTON Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/18/2018
MISSHA Signature Essence Cushion - Watering (No.23)Titanium Dioxide, Octinoxate, Octisalate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-404
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 DIOXIDE1.3146705 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
DIMETHICONE(UNII: 92RU3N3Y1O)
ADENOSINE(UNII: K72T3FS567)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
NIACINAMIDE(UNII: 25X51I8RD4)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ALCOHOL(UNII: 3K9958V90M)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
POLYMETHYLSILSESQUIOXANE (11 MICRONS)(UNII: Z570VEV8XK)
ISODODECANE(UNII: A8289P68Y2)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS(UNII: D818OLQ51Z)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-404-0115 g in 1 CARTON Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/18/2018
MISSHA Signature Essence Cushion - Covering (No.21)Titanium Dioxide, Octinoxate, Octisalate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-405
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 DIOXIDE2.122392563 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
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
NIACINAMIDE(UNII: 25X51I8RD4)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER(UNII: EG97988M5Q)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ADENOSINE(UNII: K72T3FS567)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
16-METHYLHEPTADECANOIC ACID(UNII: LZM5XA0ILL)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-405-0115 g in 1 CARTON Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/18/2018

PRINCIPAL DISPLAY PANEL

Signature Essence Cushion - Watering (No.21)

PRINCIPAL DISPLAY PANEL

Signature Essence Cushion - Watering (No.23)

PRINCIPAL DISPLAY PANEL

Signature Essence Cushion - Watering (No.21)

PRINCIPAL DISPLAY PANEL

Signature Essence Cushion - Watering (No.23)