NDC Code(s) : 13733-301-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Near Skin Dustless Defense SunblockOctinoxate, Octisalate, Zinc Oxide, Titanium Dioxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-301
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE4.9 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE2.9 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
METHYL METHACRYLATE(UNII: 196OC77688)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-301-0150 g in 1 TUBE Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2017

PRINCIPAL DISPLAY PANEL

NearSkinDustlessDefenceSunblock