NDC Code(s) : 13733-060-01
Packager : ABLE C&C CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA TIME REVOLUTION WHITE CURE BLANC SUN PROTECTOR ZINC OXIDE, OCTINOXATE, OCTISALATE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-060
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION3.75 g in 50 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3.5 g in 50 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE1 g in 50 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERETH-26(UNII: NNE56F2N14)
FREESIA ALBA FLOWER(UNII: 33X293N6JT)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
LEONTOPODIUM NIVALE SUBSP. ALPINUM WHOLE FLOWERING(UNII: 7R4LQP52DM)
HOUTTUYNIA CORDATA FLOWERING TOP(UNII: RH041UUZ22)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
SAUSSUREA INVOLUCRATA WHOLE(UNII: C7X2ALW7JZ)
BIOSACCHARIDE GUM-1(UNII: BB4PU4V09H)
CYCLOMETHICONE(UNII: NMQ347994Z)
BELLIS PERENNIS FLOWER(UNII: 26I94X9A1K)
LILIUM CANDIDUM FLOWER(UNII: COV655U2CJ)
NIACINAMIDE(UNII: 25X51I8RD4)
CHAMOMILE(UNII: FGL3685T2X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-060-0150 g in 1 CARTON Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2013

PRINCIPAL DISPLAY PANEL

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