NDC Code(s) : 59078-116-01
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 Real SerumGlycerin LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN8377.386 mg in 60 mL
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
BERGAMOT OIL(UNII: 39W1PKE3JI)
GERANIUM MACULATUM WHOLE(UNII: LFG25P7V8M)
SARGASSUM FUSIFORME(UNII: X436TJ4A11)
SANDALWOOD OIL(UNII: X7X01WMQ5F)
ROSA RUGOSA FLOWER BUD(UNII: TZ0BE8I3MW)
MATRICARIA RECUTITA ROOT(UNII: BTG5H50X7F)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
STYRAX BENZOIN RESIN(UNII: FE663Z8IRO)
MYRRH OIL(UNII: H74221J5J4)
SPIRULINA MAXIMA(UNII: 9K7IG15M0Q)
COW MILK FAT(UNII: 463JZS0XJ3)
WATER(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TROMETHAMINE(UNII: 023C2WHX2V)
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
THEANINE(UNII: 8021PR16QO)
ADENOSINE(UNII: K72T3FS567)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
GLUTATHIONE(UNII: GAN16C9B8O)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
LAVENDER OIL(UNII: ZBP1YXW0H8)
CODIUM TOMENTOSUM(UNII: B8B45BRU87)
ECKLONIA CAVA(UNII: UXX2N5V39P)
ORANGE OIL(UNII: AKN3KSD11B)
LAMINARIA JAPONICA(UNII: WE98HW412B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-116-011 in 1 CARTON 19/01/2016
160 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 01/14/2016

PRINCIPAL DISPLAY PANEL

Serum