NDC Code(s) : 13733-334-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA M Signature Real Complete BB Cream SPF25 No.23 Natural Yellow BeigeTitanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-334
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 DIOXIDE3.4731 g in 45 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.728 g in 45 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 6(UNII: XHK3U310BA)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
ARBUTIN(UNII: C5INA23HXF)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
HYDROGENATED POLYBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
BABASSU OIL(UNII: 8QSB4M5477)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
MICA(UNII: V8A1AW0880)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-334-0145 g in 1 CARTON Type 0: Not a Combination Product21/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/21/2017

PRINCIPAL DISPLAY PANEL

MISSHA M Signature Real Complete BB Cream SPF25 No.23 Natural Yellow Beige