NDC Code(s) : 62307-251-01
Packager : Isis Enterprises LLC DBA: S4 Suncare

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

S4 Sunscreen Stick Titanium Dioxide, Zinc Oxide STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62307-251
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE5.80 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION4.51 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ARGANIA SPINOSA SEED(UNII: 8H7X7XB54H)
YELLOW WAX(UNII: 2ZA36H0S2V)
LEVOMENOL(UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(UNII: U72Q2I8C85)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CANDELILLA WAX(UNII: WL0328HX19)
HYDROGENATED COCO-GLYCERIDES(UNII: XDD37N2GPR)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOSTEARYL ISOSTEARATE(UNII: IV0Z586Z4Y)
LANOLIN(UNII: 7EV65EAW6H)
CERESIN(UNII: Q1LS2UJO3A)
RICINUS COMMUNIS SEED(UNII: 7EK4SFN1TX)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62307-251-0117 g in 1 VIAL Type 0: Not a Combination Product04/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/01/2014

PRINCIPAL DISPLAY PANEL

Sport Stick