NDC Code(s) : 59078-118-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Bio EX Active-Cell Night CreamGlycerin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-118
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN5.05 g in 50 g
Inactive Ingredients
Ingredient Name Strength
STEARIC ACID(UNII: 4ELV7Z65AP)
MEADOWFOAM SEED OIL(UNII: 412ZHA4T4Y)
MATRICARIA RECUTITA(UNII: G0R4UBI2ZZ)
MYRRH OIL(UNII: H74221J5J4)
SPIRULINA MAXIMA(UNII: 9K7IG15M0Q)
MANGIFERA INDICA SEED BUTTER(UNII: 4OXD9M35X2)
TREHALOSE(UNII: B8WCK70T7I)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PEG-100 STEARATE(UNII: YD01N1999R)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
NIACINAMIDE(UNII: 25X51I8RD4)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
DIMETHICONE(UNII: 92RU3N3Y1O)
ADENOSINE(UNII: K72T3FS567)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
THEANINE(UNII: 8021PR16QO)
GLUTATHIONE(UNII: GAN16C9B8O)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
MACADAMIA OIL(UNII: 515610SU8C)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALCOHOL(UNII: 3K9958V90M)
ORANGE OIL(UNII: AKN3KSD11B)
LAMINARIA JAPONICA(UNII: WE98HW412B)
EDETATE DISODIUM(UNII: 7FLD91C86K)
LAVENDER OIL(UNII: ZBP1YXW0H8)
SARGASSUM FUSIFORME(UNII: X436TJ4A11)
ECKLONIA CAVA(UNII: UXX2N5V39P)
CODIUM TOMENTOSUM(UNII: B8B45BRU87)
GELIDIUM CARTILAGINEUM(UNII: 37LBZ0E1UE)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
COW MILK FAT(UNII: 463JZS0XJ3)
GERANIUM MACULATUM ROOT OIL(UNII: H2E371EDYX)
SANDALWOOD OIL(UNII: X7X01WMQ5F)
ROSA RUGOSA FLOWER BUD(UNII: TZ0BE8I3MW)
STYRAX BENZOIN RESIN(UNII: FE663Z8IRO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-118-011 in 1 CARTON 19/01/2016
150 g in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 01/14/2016

PRINCIPAL DISPLAY PANEL

Eye Face Cream