NDC Code(s) : 13733-236-01, 13733-237-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISA Geum Sul Vitalizing BB Cake 21Titanium Dioxide, Octinoxate POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-236
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE5.5 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE16.4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PENTYLENE GLYCOL(UNII: 50C1307PZG)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
WATER(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
CERESIN(UNII: Q1LS2UJO3A)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
DIMETHICONE(UNII: 92RU3N3Y1O)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
METHYL METHACRYLATE(UNII: 196OC77688)
SORBITAN OLIVATE(UNII: MDL271E3GR)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-236-0120 g in 1 CARTON Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2017
MISA Geum Sul Vitalizing BB Cake 23Titanium Dioxide, Octinoxate POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-237
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE5.5 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE16.4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
WATER(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
CERESIN(UNII: Q1LS2UJO3A)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
DIMETHICONE(UNII: 92RU3N3Y1O)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
METHYL METHACRYLATE(UNII: 196OC77688)
SORBITAN OLIVATE(UNII: MDL271E3GR)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-237-0120 g in 1 CARTON Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2017

PRINCIPAL DISPLAY PANEL

MisaGeumsulVitalizingBBCake21R

PRINCIPAL DISPLAY PANEL

MisaGeumsulVitalizingBBCake23R