NDC Code(s) : 69039-270-00
Packager : Sun Bum LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sun Bum Mineral SPF30 SunscreenZINC OXIDE STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69039-270
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 CATION80 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WHITE WAX(UNII: 7G1J5DA97F)
JOJOBA OIL(UNII: 724GKU717M)
SHEA BUTTER(UNII: K49155WL9Y)
CANDELILLA WAX(UNII: WL0328HX19)
ARGAN OIL(UNII: 4V59G5UW9X)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CARNAUBA WAX(UNII: R12CBM0EIZ)
TOCOPHEROL(UNII: R0ZB2556P8)
SOYBEAN OIL(UNII: 241ATL177A)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
LEVOMENOL(UNII: 24WE03BX2T)
ISOSTEARIC ACID(UNII: X33R8U0062)
GLYCERYL 1-UNDECYLENATE(UNII: B68LJT9544)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69039-270-004.25 g in 1 CARTRIDGE Type 0: Not a Combination Product15/04/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/15/2018

PRINCIPAL DISPLAY PANEL

Label6