NDC Code(s) : 43479-202-12, 43479-202-52
Packager : KATE SOMERVILLE SKINCARE, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DAILY DEFLECTOR MOISTURIZER AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43479-202
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE10 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE6 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
GLYCERIN(UNII: PDC6A3C0OX)
UNDECYL ETHYLENEGLYCOL MONOETHER(UNII: H0Z032IC7M)
DIMETHICONE(UNII: 92RU3N3Y1O)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
TOCOPHEROL(UNII: R0ZB2556P8)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
LENTINULA EDODES MYCELIUM(UNII: CU2S39TB8O)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
TREHALOSE(UNII: B8WCK70T7I)
TRIACETIN(UNII: XHX3C3X673)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
PEG-20 METHYL GLUCOSE SESQUISTEARATE(UNII: 0345752X7U)
CARBOMER INTERPOLYMER TYPE A (55000 CPS)(UNII: 59TL3WG5CO)
BENTONITE(UNII: A3N5ZCN45C)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
POLIGNATE SODIUM(UNII: XY2KOA860T)
SODIUM POLYACRYLATE (8000 MW)(UNII: 285CYO341L)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
UREA(UNII: 8W8T17847W)
CARBOMER 940(UNII: 4Q93RCW27E)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
SODIUM LACTATE(UNII: TU7HW0W0QT)
POLYSORBATE 20(UNII: 7T1F30V5YH)
DISODIUM CARBOXYETHYL SILICONATE(UNII: 4U4C79679G)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
KAOLIN(UNII: 24H4NWX5CO)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
AMINOMETHYLPROPANOL(UNII: LU49E6626Q)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BENZOIC ACID(UNII: 8SKN0B0MIM)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CHLORPHENESIN(UNII: I670DAL4SZ)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43479-202-521 in 1 BOX
1NDC:43479-202-1250 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/22/2014

PRINCIPAL DISPLAY PANEL

DailyDeflectorMoiturizer50+_Carton_032613OL