NDC Code(s) : 59078-137-02
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Timeless Ferment Snail BB CreamTitanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-137
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 OXIDE5610 mg in 50 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE423 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
IMPERATA CYLINDRICA ROOT(UNII: VYT2JA85NH)
STEARETH-20(UNII: L0Q8IK9E08)
N-HYDROXYSUCCINIMIDE(UNII: MJE3791M4T)
SODIUM BENZOATE(UNII: OJ245FE5EU)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ADENOSINE(UNII: K72T3FS567)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
LIME OIL(UNII: UZH29XGA8G)
PINE NEEDLE OIL (PINUS SYLVESTRIS)(UNII: 5EXL5H740Y)
EUCALYPTUS OIL(UNII: 2R04ONI662)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BABASSU OIL(UNII: 8QSB4M5477)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
MAGNESIUM SULFATE(UNII: DE08037SAB)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
WATER(UNII: 059QF0KO0R)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
LEMON OIL(UNII: I9GRO824LL)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
ROSA CANINA FRUIT OIL(UNII: CR7307M3QZ)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
XANTHAN GUM(UNII: TTV12P4NEE)
ZANTHOXYLUM PIPERITUM FRUIT PULP(UNII: 7PFC2VA251)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
CHRYSIN(UNII: 3CN01F5ZJ5)
NIACINAMIDE(UNII: 25X51I8RD4)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
USNEA BARBATA(UNII: D6DVA9TCAP)
PULSATILLA KOREANA ROOT(UNII: FY35I16MPL)
ACETYL HEXAPEPTIDE-8(UNII: L4EL31FWIL)
CHLORHEXIDINE GLUCONATE(UNII: MOR84MUD8E)
BERGAMOT OIL(UNII: 39W1PKE3JI)
ORANGE OIL(UNII: AKN3KSD11B)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-137-021 in 1 CARTON 01/11/2016
150 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 final part347 01/10/2016

PRINCIPAL DISPLAY PANEL

Timeless_Ferment_Snail_BB_Cream