NDC Code(s) : 59078-109-02
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Aqua Aura Jelly Cushion01 SPF36 Pure BeigeTitanium Dioxide POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-109
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 DIOXIDE2.381 g in 10 g
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
BENTOQUATAM(UNII: 7F465U79Q1)
GLYCERIN(UNII: PDC6A3C0OX)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
LAUROYL LYSINE(UNII: 113171Q70B)
MICA(UNII: V8A1AW0880)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MORINGA OLEIFERA SEED(UNII: TIX5482832)
WATER(UNII: 059QF0KO0R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPYL GALLATE(UNII: 8D4SNN7V92)
PEARL (HYRIOPSIS CUMINGII)(UNII: A75L5FZ40U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-109-021 in 1 CARTON 14/01/2016
110 g in 1 CASE 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 part352 01/14/2016

PRINCIPAL DISPLAY PANEL

Case