NDC Code(s) : 63354-860-16
Packager : Edgewell Personal Care Brands, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Banana BoatAvobenzone, Homosalate, Octisalate, Octocrylene OIL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-860
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE3.2 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2.4 g in 100 g
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE4.5 g in 100 g
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL(UNII: T5L8T28FGP)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
DIETHYLHEXYL 2,6-NAPHTHALATE(UNII: I0DQJ7YGXM)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
COCONUT OIL(UNII: Q9L0O73W7L)
GRAPE SEED OIL(UNII: 930MLC8XGG)
THEOBROMA CACAO WHOLE(UNII: EB048G1S9J)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SUNFLOWER OIL(UNII: 3W1JG795YI)
CORN OIL(UNII: 8470G57WFM)
CARROT(UNII: L56Z1JK48B)
BANANA(UNII: 4AJZ4765R9)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63354-860-16236 g in 1 BOTTLE Type 0: Not a Combination Product01/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 01/01/2014

LABELER - Edgewell Personal Care Brands, LLC(151179769)

PRINCIPAL DISPLAY PANEL

BANANA
BOAT®
PROTECTIVE
SPRAY OIL
SUNSCREEN SPRAY
UVA/UVB BROAD SPECTRUM SPF 15
15
WITH COCONUT OIL
Skin Nourishing Formula
Water Resistant
(80 Minutes)
8 FL. OZ. (236 mL)

Front Label

Front Label