NDC Code(s) : 43419-004-02
Packager : AMOREPACIFIC CORPORATION

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sulwhasoo OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.8 g in 40 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE1.8 g in 40 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE3.2 g in 40 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.768 g in 40 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.0412 g in 40 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
GLYCYRRHIZA URALENSIS(UNII: 42B5YD8F0K)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ASIAN GINSENG(UNII: CUQ3A77YXI)
PEG-100 STEARATE(UNII: YD01N1999R)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETYL ALCOHOL(UNII: 936JST6JCN)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
PEG-40 STEARATE(UNII: ECU18C66Q7)
ALUMINUM OXIDE(UNII: LMI26O6933)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
NELUMBO NUCIFERA SEED(UNII: YCT65RT6AE)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
LILIUM LANCIFOLIUM FLOWERING TOP(UNII: 6268MFA917)
REHMANNIA GLUTINOSA ROOT(UNII: 1BEM3U6LQQ)
POLYGONATUM ODORATUM ROOT(UNII: KPF03O64AZ)
STEARIC ACID(UNII: 4ELV7Z65AP)
CHRYSANTHEMUM X MORIFOLIUM FLOWER(UNII: 2GR3C1A0WV)
TANGERINE PEEL(UNII: JU3D414057)
XANTHAN GUM(UNII: TTV12P4NEE)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED(UNII: 8DW238I7ZI)
ADENOPHORA STRICTA ROOT(UNII: C768H06N7E)
GLYCERIN(UNII: PDC6A3C0OX)
OPHIOPOGON JAPONICUS ROOT(UNII: 90PS6JV9GZ)
HONEY(UNII: Y9H1V576FH)
MACHILUS THUNBERGII BARK(UNII: Y4097QKS9T)
LYCIUM CHINENSE ROOT BARK(UNII: 2Q9D9P290N)
PAEONIA X SUFFRUTICOSA ROOT(UNII: 7M7E9A2C8J)
PROPANEDIOL(UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
LIGUSTICUM TENUISSIMUM ROOT(UNII: 2O0H84E074)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
MYRISTIC ACID(UNII: 0I3V7S25AW)
STEARYL BEHENATE(UNII: A68S9UI39D)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-004-021 in 1 CARTON 05/01/2011
140 mL in 1 TUBE 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 05/01/2011

PRINCIPAL DISPLAY PANEL

Sulwhasoo

AGE-VEIL
UV PROTECTION CREAM

SPF30+
sunscreen

40 ml / 1.35 fl. oz.

Principal Display Panel - 40 ml Tube Carton