NDC Code(s) : 13733-232-01
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 Day SPF15Octinoxate, Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-232
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 DIOXIDE0.026 g in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.07 g in 1 g
Inactive Ingredients
Ingredient Name Strength
CHINESE CINNAMON(UNII: WS4CQ062KM)
WHITE MULBERRY(UNII: MN25R0HH5A)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
ARTEMISIA PRINCEPS LEAF(UNII: SY077EW02G)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
PANAX GINSENG ROOT WATER(UNII: P9T4K47OM0)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
ARBUTIN(UNII: C5INA23HXF)
POLYSORBATE 60(UNII: CAL22UVI4M)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL ALCOHOL(UNII: 936JST6JCN)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALCOHOL(UNII: 3K9958V90M)
PALMITIC ACID(UNII: 2V16EO95H1)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ASIAN GINSENG(UNII: CUQ3A77YXI)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
WATER(UNII: 059QF0KO0R)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
GLYCERYL 1-STEARATE(UNII: 258491E1RZ)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARIC ACID(UNII: 4ELV7Z65AP)
REISHI(UNII: TKD8LH0X2Z)
CHLORPHENESIN(UNII: I670DAL4SZ)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
ADENOSINE(UNII: K72T3FS567)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
CHRYSANTHEMUM INDICUM FLOWER(UNII: I6OER6U04L)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)
CARBOMER INTERPOLYMER TYPE A (55000 CPS)(UNII: 59TL3WG5CO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-232-0150 g in 1 CONTAINER Type 0: Not a Combination Product21/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/21/2016

PRINCIPAL DISPLAY PANEL

MisaGeumSulVitalizingDayCreamR