NDC Code(s) : 51621-203-01, 51621-203-02
Packager : GOWOONSESANG COSMETICS CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr.G Water Proof Up SunOCTINOXATE, HOMOSALATE, OCTISALATE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51621-203
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE60 mg in 1 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE50 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE(UNII: ANQ870JD20)
PROPANEDIOL(UNII: 5965N8W85T)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
CHIA SEED(UNII: NU0OLX06F8)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
HOUTTUYNIA CORDATA FLOWERING TOP(UNII: RH041UUZ22)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
INVERT SUGAR(UNII: ED959S6ACY)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
TROLAMINE(UNII: 9O3K93S3TK)
PULLULAN(UNII: 8ZQ0AYU1TT)
OCTYLDODECANOL(UNII: 461N1O614Y)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CHAMAEMELUM NOBILE FLOWER(UNII: O2T154T6OG)
ECHIUM PLANTAGINEUM SEED OIL(UNII: PIB7XBU8XW)
SUNFLOWER OIL(UNII: 3W1JG795YI)
AVOCADO(UNII: SDS87L369F)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
CARDIOSPERMUM HALICACABUM FLOWERING TOP(UNII: MZP2508BRR)
DIMETHICONE(UNII: 92RU3N3Y1O)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYSORBATE 20(UNII: 7T1F30V5YH)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
TOCOPHEROL(UNII: R0ZB2556P8)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
PEG-100 STEARATE(UNII: YD01N1999R)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
OLETH-10(UNII: JD797EF70J)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ALUMINUM OXIDE(UNII: LMI26O6933)
ISODECETH-6(UNII: 278Z9G87XH)
TERT-BUTYL ALCOHOL(UNII: MD83SFE959)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51621-203-021 in 1 CARTON 02/08/2017
1NDC:51621-203-0170 mL 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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