NDC Code(s) : 59078-119-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY My Sunny Touch Free Sun BlockTitanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-119
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 OXIDE2.52 g in 40 g
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN2.268 g in 40 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM PALMITOYL PROLINE(UNII: 64L053FRFO)
POLYGONUM CUSPIDATUM ROOT(UNII: 7TRV45YZF7)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
ARABICA COFFEE BEAN(UNII: 3SW678MX72)
NYMPHAEA ALBA FLOWER(UNII: 40KQ7Q535O)
WATER(UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
STEARIC ACID(UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
MICA(UNII: V8A1AW0880)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
NIACINAMIDE(UNII: 25X51I8RD4)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ADENOSINE(UNII: K72T3FS567)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
CAPRYLHYDROXAMIC ACID(UNII: UPY805K99W)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PORTULACA OLERACEA WHOLE(UNII: D5J3623SV2)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CASTANEA CRENATA SHELL(UNII: MTF3V701OO)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
MORINGA OLEIFERA SEED(UNII: TIX5482832)
GRAPEFRUIT(UNII: O82C39RR8C)
SAFFLOWER(UNII: 4VBL71TY4Y)
PRUNUS MUME FRUIT OIL(UNII: I4HW888TQ6)
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
CHENOPODIUM QUINOA SEED(UNII: OO4K72NZ2X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-119-011 in 1 CARTON 19/01/2016
140 g in 1 TUBE 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

sun block