NDC Code(s) : 59078-123-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY My Sunny Tok Tok Sun PowderTitanium Dioxide POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-123
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 DIOXIDE0.3651 g in 3 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.0576 g in 3 g
Inactive Ingredients
Ingredient Name Strength
TANGERINE(UNII: KH3E3096OO)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
MELISSA OFFICINALIS(UNII: YF70189L0N)
NYMPHAEA ALBA FLOWER(UNII: 40KQ7Q535O)
STARCH, CORN(UNII: O8232NY3SJ)
PLATINUM(UNII: 49DFR088MY)
MICA(UNII: V8A1AW0880)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
TALC(UNII: 7SEV7J4R1U)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)
LAUROYL LYSINE(UNII: 113171Q70B)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
WATER(UNII: 059QF0KO0R)
BEMOTRIZINOL(UNII: PWZ1720CBH)
2-ETHYLHEXYL ACRYLATE(UNII: HR49R9S6XG)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP(UNII: 08H094218D)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-123-011 in 1 CARTON 19/01/2016
13 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 final part352 01/14/2016

PRINCIPAL DISPLAY PANEL

PRODUCT