NDC Code(s) : 43419-716-10, 43419-716-11, 43419-716-12
Packager : AMOREPACIFIC CO.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sulwhasoo Lumitouch OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-716
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.9 mL in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE2.584 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.2939 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
SQUALANE(UNII: GW89575KF9)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PAPRIKA(UNII: X72Z47861V)
GARDENIA FRUIT EXTRACT(UNII: 7CTH8MD549)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CHRYSANTHEMUM X MORIFOLIUM FLOWER(UNII: 2GR3C1A0WV)
TANGERINE(UNII: KH3E3096OO)
REHMANNIA GLUTINOSA ROOT(UNII: 1BEM3U6LQQ)
LILIUM TIGRINUM(UNII: 47Z05W73EZ)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
NELUMBO NUCIFERA SEED(UNII: YCT65RT6AE)
HONEY(UNII: Y9H1V576FH)
LYCIUM CHINENSIS FRUCTUS(UNII: TG711Q7A1Q)
LIGUSTICUM TENUISSIMUM LEAF(UNII: U9Q450Q978)
ANGELICA ACUTILOBA ROOT(UNII: 3W51R3EK30)
TRICHOSANTHES KIRILOWII ROOT(UNII: V409XGE0TS)
GLYCERIN(UNII: PDC6A3C0OX)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CALCIUM STEARATE(UNII: 776XM7047L)
ALCOHOL(UNII: 3K9958V90M)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
OCTYLTRIETHOXYSILANE(UNII: LDC331P08E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
STEARIC ACID(UNII: 4ELV7Z65AP)
OLEANOLIC ACID(UNII: 6SMK8R7TGJ)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
XANTHAN GUM(UNII: TTV12P4NEE)
BARIUM SULFATE(UNII: 25BB7EKE2E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-716-1030 mL in 1 BOTTLE
2NDC:43419-716-1130 mL in 1 BOTTLE
3NDC:43419-716-1230 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 09/01/2010

PRINCIPAL DISPLAY PANEL

Sulwhasoo

LUMITOUCH FOUNDATION (LIQUID)

SPF 15, PA+

1.0 fl. oz. e / 30 ml

Principal Display Panel - 30 ml Bottle Carton