NDC Code(s) : 51621-202-01, 51621-202-02
Packager : GOWOONSESANG COSMETICS CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr.G Green Mild Up SunZINC OXIDE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51621-202
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 CATION116.4 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE31.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
PROPANEDIOL(UNII: 5965N8W85T)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)(UNII: RLA2U05Z4Q)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
CHIA SEED(UNII: NU0OLX06F8)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
HOUTTUYNIA CORDATA FLOWERING TOP(UNII: RH041UUZ22)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE(UNII: 9229XJ4V12)
STEARIC ACID(UNII: 4ELV7Z65AP)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
INVERT SUGAR(UNII: ED959S6ACY)
PULLULAN(UNII: 8ZQ0AYU1TT)
BERGAMOT OIL(UNII: 39W1PKE3JI)
SUNFLOWER OIL(UNII: 3W1JG795YI)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
OCTYLDODECANOL(UNII: 461N1O614Y)
PELARGONIUM GRAVEOLENS FLOWER OIL(UNII: 3K0J1S7QGC)
SAFFLOWER OIL(UNII: 65UEH262IS)
HOREHOUND(UNII: K08036XEJV)
ROSA DAMASCENA FLOWER OIL(UNII: 18920M3T13)
ECHIUM PLANTAGINEUM SEED OIL(UNII: PIB7XBU8XW)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES(UNII: XO45V955LT)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
SOYBEAN OIL(UNII: 241ATL177A)
WHEAT GERM OIL(UNII: 14C97E680P)
GLYCERIN(UNII: PDC6A3C0OX)
TAGETES ERECTA FLOWER(UNII: UH5X33P33E)
CARDIOSPERMUM HALICACABUM FLOWERING TOP(UNII: MZP2508BRR)
BEE POLLEN(UNII: 3729L8MA2C)
MARITIME PINE(UNII: 50JZ5Z98QY)
BIOSACCHARIDE GUM-4(UNII: 9XRL057X90)
CHOLESTEROL(UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CERAMIDE 1(UNII: 5THT33P7X7)
CERAMIDE NG(UNII: C04977SRJ5)
CERAMIDE NP(UNII: 4370DF050B)
CERAMIDE AP(UNII: F1X8L2B00J)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
TOCOPHEROL(UNII: R0ZB2556P8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51621-202-021 in 1 CARTON 02/08/2017
1NDC:51621-202-0150 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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