NDC Code(s) : 13733-233-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Time Revolution White Cure Blanc Tone Up Sun ProtectorZinc Oxide, Octinoxate, Octisalate, Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-233
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE10.2 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE2 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.7 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
NIACINAMIDE(UNII: 25X51I8RD4)
BELLIS PERENNIS FLOWER(UNII: 26I94X9A1K)
GLYCERETH-26(UNII: NNE56F2N14)
FREESIA ALBA FLOWER(UNII: 33X293N6JT)
LILIUM CANDIDUM FLOWER(UNII: COV655U2CJ)
SAUSSUREA INVOLUCRATA WHOLE(UNII: C7X2ALW7JZ)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
CHAMOMILE(UNII: FGL3685T2X)
LEONTOPODIUM ALPINUM(UNII: 7R4LQP52DM)
HOUTTUYNIA CORDATA FLOWERING TOP(UNII: RH041UUZ22)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
BIOSACCHARIDE GUM-1(UNII: BB4PU4V09H)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-233-0150 g in 1 BOTTLE Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/01/2017

PRINCIPAL DISPLAY PANEL

TimeRevolutionWhiteCureBlancToneupSunProtector