NDC Code(s) : 13733-350-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA M Essential Care Lip Treatment SPF15OCTISALATE, OCTINOXATE LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-350
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE0.39 g in 13 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.78 g in 13 mL
Inactive Ingredients
Ingredient Name Strength
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
ANGELICA ACUTILOBA ROOT(UNII: 3W51R3EK30)
LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT(UNII: SDW6SS1K6I)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
SORBITOL(UNII: 506T60A25R)
RHODODENDRON FERRUGINEUM WHOLE(UNII: FO6B1S7BZU)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
YELLOW WAX(UNII: 2ZA36H0S2V)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
MEADOWLACTONE(UNII: 3OY5Q13U9R)
SUNFLOWER OIL(UNII: 3W1JG795YI)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
CERAMIDE AP(UNII: F1X8L2B00J)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
CHOLESTERYL HYDROXYSTEARATE(UNII: O6K1LG6N4D)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
TOCOPHEROL(UNII: R0ZB2556P8)
ALCOHOL(UNII: 3K9958V90M)
PANTHENOL(UNII: WV9CM0O67Z)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
CASTOR OIL(UNII: D5340Y2I9G)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
HYALURONIC ACID(UNII: S270N0TRQY)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-350-0113 mL in 1 CARTON Type 0: Not a Combination Product15/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/15/2017

PRINCIPAL DISPLAY PANEL

MISSHA M ESSENTIAL CARE LIP TREATMENT SPF 15