NDC Code 43419-018-02 | pharmacompass.com

NDC Code(s) : 43419-018-02
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sulwhasoo Lumitouch Base OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43419-018
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.9 g in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.249 g in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.294 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
SQUALANE(UNII: GW89575KF9)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALCOHOL(UNII: 3K9958V90M)
CALCIUM STEARATE(UNII: 776XM7047L)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
STEARIC ACID(UNII: 4ELV7Z65AP)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE DISODIUM(UNII: 7FLD91C86K)
OLEANOLIC ACID(UNII: 6SMK8R7TGJ)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
XANTHAN GUM(UNII: TTV12P4NEE)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
CHRYSANTHEMUM X MORIFOLIUM FLOWER(UNII: 2GR3C1A0WV)
TANGERINE PEEL(UNII: JU3D414057)
DIOSCOREA JAPONICA TUBER(UNII: I43FCF3356)
CORNUS OFFICINALIS FRUIT(UNII: 23NL8NQ187)
POLYGONATUM ODORATUM ROOT(UNII: KPF03O64AZ)
NELUMBO NUCIFERA SEED(UNII: YCT65RT6AE)
REHMANNIA GLUTINOSA ROOT(UNII: 1BEM3U6LQQ)
LILIUM LANCIFOLIUM FLOWERING TOP(UNII: 6268MFA917)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED(UNII: 8DW238I7ZI)
ADENOPHORA STRICTA ROOT(UNII: C768H06N7E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
HONEY(UNII: Y9H1V576FH)
LYCIUM CHINENSE ROOT BARK(UNII: 2Q9D9P290N)
PAEONIA SUFFRUTICOSA ROOT(UNII: 7M7E9A2C8J)
GARDENIA JASMINOIDES FRUIT(UNII: 7CTH8MD549)
PAPRIKA(UNII: X72Z47861V)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PERSICARIA TINCTORIA LEAF(UNII: FU6582QMPV)
LIGUSTICUM TENUISSIMUM ROOT(UNII: 2O0H84E074)
ANGELICA ACUTILOBA ROOT(UNII: 3W51R3EK30)
TRICHOSANTHES KIRILOWII ROOT(UNII: V409XGE0TS)
MAGNESIUM MYRISTATE(UNII: Z1917F0578)
ULTRAMARINE BLUE(UNII: I39WR998BI)
FERRIC OXIDE RED(UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-018-02	30 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/03/2012

NDC 43419-018-02
API & Excipient Details

marketed by AMOREPACIFIC under NDC Code 43419-018-02

NDC Code(s) : 43419-018-02
Packager : AMOREPACIFIC

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 43419-018-02 API & Excipient Details

marketed by AMOREPACIFIC under NDC Code 43419-018-02

NDC Code(s) : 43419-018-02Packager : AMOREPACIFIC

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 43419-018-02
API & Excipient Details

NDC Code(s) : 43419-018-02
Packager : AMOREPACIFIC