NDC Code(s) : 13733-345-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA Skin Fit Stick Foundation SPF50 No.21ZINC OXIDE, TITANIUM DIOXIDE, OCTISALATE, OCTINOXATE, OCTOCRYLENE STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-345
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.9408 g in 14 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE3.04185 g in 14 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE0.42 g in 14 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.98 g in 14 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE0.63 g in 14 g
Inactive Ingredients
Ingredient Name Strength
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
BENTOQUATAM(UNII: 7F465U79Q1)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
WATER(UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
HYDROGENATED POLYBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
BEMOTRIZINOL(UNII: PWZ1720CBH)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
OLIVE OIL(UNII: 6UYK2W1W1E)
ROSA CANINA FRUIT OIL(UNII: CR7307M3QZ)
TOCOPHEROL(UNII: R0ZB2556P8)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
GLYCERIN(UNII: PDC6A3C0OX)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
ADENOSINE(UNII: K72T3FS567)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
16-METHYLHEPTADECANOIC ACID(UNII: LZM5XA0ILL)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-345-0114 g in 1 CARTON Type 0: Not a Combination Product16/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/16/2017

PRINCIPAL DISPLAY PANEL

MISSHA Skin Fit Stick Foundation SPF50 No.21 MISSHA Skin Fit Stick Foundation SPF50 No.21