NDC Code(s) : 51621-201-01, 51621-201-02
Packager : GOWOONSESANG COSMETICS CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr.G Brightening Up Sun StickOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51621-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE70 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE45 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE29 mg in 1 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
THERMUS THERMOPHILUS LYSATE(UNII: 775R692494)
MICA(UNII: V8A1AW0880)
PARAFFIN(UNII: I9O0E3H2ZE)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE(UNII: ANQ870JD20)
BEMOTRIZINOL(UNII: PWZ1720CBH)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
WATER(UNII: 059QF0KO0R)
CHAMAEMELUM NOBILE FLOWER OIL(UNII: UB27587839)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
PANTHENOL(UNII: WV9CM0O67Z)
BIOSACCHARIDE GUM-4(UNII: 9XRL057X90)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALCOHOL(UNII: 3K9958V90M)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GRAPE SEED OIL(UNII: 930MLC8XGG)
SODIUM PALMITOYL PROLINE(UNII: 64L053FRFO)
CERAMIDE NP(UNII: 4370DF050B)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
CHOLESTEROL(UNII: 97C5T2UQ7J)
NYMPHAEA ALBA FLOWER(UNII: 40KQ7Q535O)
PINUS MUGO SUBSP. MUGO BARK(UNII: SBJ2CP47EE)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
BENZYL ALCOHOL(UNII: LKG8494WBH)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
SHEANUT(UNII: 84H6HBP32L)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
SODIUM POLYACRYLATE (8000 MW)(UNII: 285CYO341L)
HEDERA HELIX LEAF(UNII: ZP9XFG71A7)
SUNFLOWER SEED(UNII: R9N3379M4Z)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
PPG-1-PEG-9 LAURYL GLYCOL ETHER(UNII: 5R8J43K25L)
FYTIC ACID(UNII: 7IGF0S7R8I)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
PURSLANE(UNII: M6S840WXG5)
DEHYDROACETIC ACID(UNII: 2KAG279R6R)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51621-201-021 in 1 CARTON 02/08/2017
1NDC:51621-201-0115 g in 1 CONTAINER 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 08/02/2017

PRINCIPAL DISPLAY PANEL

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