NDC Code(s) : 63354-201-34
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, Oxybenzone SPRAY
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE10 g in 100 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE6 g in 100 g
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ISOBUTANE(UNII: BXR49TP611)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
METHYL DIHYDROABIETATE(UNII: 7666FJ0J9F)
WATER(UNII: 059QF0KO0R)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
MINERAL OIL(UNII: T5L8T28FGP)
PANTHENOL(UNII: WV9CM0O67Z)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63354-201-34170 g in 1 CAN 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)

Establishment
Name Address ID/FEI Business Operations
Playtex Manufacturing Inc 963501502 manufacture(63354-201)

PRINCIPAL DISPLAY PANEL

BANANA
BOAT®
SPORT
ultra
CLEAR SUNSCREEN SPRAY
BROAD SPECTRUM SPF 100
100
CLINICALLY
PROVEN
UVA/UVB PROTECTION
SUPERIOR ENDURANCE
VS. SWEAT & WATER
Water Resistant
(80 Minutes)
NET WT 6 OZ. (170 g)

Label