NDC Code(s) : 43419-719-28, 43419-719-29, 43419-719-30
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 CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-719
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.352 g in 11 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.533 g in 11 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.216 g in 11 g
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
MICA(UNII: V8A1AW0880)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
BORON(UNII: N9E3X5056Q)
DIMETHICONE(UNII: 92RU3N3Y1O)
OCTYLTRIETHOXYSILANE(UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
BARIUM SULFATE(UNII: 25BB7EKE2E)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PAPRIKA OIL(UNII: 04E91XC023)
CHRYSANTHEMUM X MORIFOLIUM FLOWER(UNII: 2GR3C1A0WV)
TANGERINE(UNII: KH3E3096OO)
FRUIT(UNII: C2AIY4ERZC)
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)
TRICHOSANTHES KIRILOWII ROOT(UNII: V409XGE0TS)
MAGNESIUM(UNII: I38ZP9992A)
GLYCERIN(UNII: PDC6A3C0OX)
SCUTELLARIA LATERIFLORA TOP(UNII: C6CNB75R61)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-719-2811 g in 1 JAR
2NDC:43419-719-2911 g in 1 JAR
3NDC:43419-719-3011 g in 1 JAR
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 TWINCAKE

SPF25, PA++

0.4 oz. e / 11 g

Principal Display Panel - 11 g Jar Carton