NDC Code(s) : 63354-323-34, 63354-323-36
Packager : Edgewell Personal Care Brands, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BANANA BOATHOMOSALATE OCTOCRYLENE SPRAY
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-323
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE3 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ISOBUTANE(UNII: BXR49TP611)
ISODODECANE(UNII: A8289P68Y2)
DIISOPROPYL ADIPATE(UNII: P7E6YFV72X)
MINERAL OIL(UNII: T5L8T28FGP)
METHYL DIHYDROABIETATE(UNII: 7666FJ0J9F)
ARGAN OIL(UNII: 4V59G5UW9X)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
PANTHENOL(UNII: WV9CM0O67Z)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63354-323-34170 g in 1 CAN Type 0: Not a Combination Product24/02/2015
2NDC:63354-323-36227 g in 1 CAN Type 0: Not a Combination Product24/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 02/24/2015

LABELER - Edgewell Personal Care Brands, LLC(151179769)

PRINCIPAL DISPLAY PANEL

BANANA
BOAT®
DEEP TANNING
DRY OIL
CLEAR SUNSCREEN SPRAY SPF 4
4
WITH
COCONUT OIL
MOISTURIZES
SKIN
Lightweight, Non-greasy
Water Resistant
(80 Minutes)
NET WT 6 OZ. (170 g)

Label