NDC Code(s) : 71585-101-11
Packager : SALT AND STONE

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PREMIUM SUNSCREEN FACE ZINC OXIDE, OCTINOXATE STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71585-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION15 g in 100 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL(UNII: 3W1JG795YI)
COCONUT OIL(UNII: Q9L0O73W7L)
YELLOW WAX(UNII: 2ZA36H0S2V)
SHEA BUTTER(UNII: K49155WL9Y)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CARNAUBA WAX(UNII: R12CBM0EIZ)
COCOA BUTTER(UNII: 512OYT1CRR)
MICA(UNII: V8A1AW0880)
JOJOBA OIL(UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71585-101-1130 g in 1 TUBE Type 0: Not a Combination Product29/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/29/2017

PRINCIPAL DISPLAY PANEL

BigFace stick wrap label_90PCT_revised