NDC Code(s) : 63354-755-21, 63354-755-54, 63354-755-56, 63354-755-27
Packager : Edgewell Personal Care Brands, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Banana BoatTitanium Dioxide, Zinc Oxide LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-755
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE4.5 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE6.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ISOHEXADECANE(UNII: 918X1OUF1E)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ALUMINUM OXIDE(UNII: LMI26O6933)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
WATER(UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
ETHYLHEXYL METHOXYCRYLENE(UNII: S3KFG6Q5X8)
GLYCERIN(UNII: PDC6A3C0OX)
METHYL DIHYDROABIETATE(UNII: 7666FJ0J9F)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63354-755-2129 g in 1 TUBE Type 0: Not a Combination Product01/02/2017
2NDC:63354-755-54177 g in 1 BOTTLE Type 0: Not a Combination Product01/02/2017
3NDC:63354-755-56221 g in 1 BOTTLE Type 0: Not a Combination Product01/02/2017
4NDC:63354-755-27270 g in 1 TUBE Type 0: Not a Combination Product01/02/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 01/02/2017

LABELER - Edgewell Personal Care Brands, LLC(151179769)

PRINCIPAL DISPLAY PANEL

BANANA
BOAT
NEW
LOOK!
KiDS
SPORT
SUNSCREEN LOTION
UVA/UVB BROAD SPRECTRUM SPF 50+
50+
with
POWERSTAY
TECHNOLOGY
tear+sting free
High Endurance vs. Sweat & Water
Water Resistant
(80 Minutes)
1 FL.OZ. (29 mL)

Label

BANANA
BOAT
NEW
LOOK!
KiDS
SPORT
SUNSCREEN LOTION
UVA/UVB BROAD SPRECTRUM SPF 50+
50+
with
POWERSTAY
TECHNOLOGY
tear+sting free
High Endurance vs. Sweat & Water
Water Resistant
(80 Minutes)
6 FL.OZ. (177 mL)

Label

BONUS
25% MORE
7.5 oz vs 6 oz
BANANA
BOAT
NEW
LOOK!
KiDS
SPORT
SUNSCREEN LOTION
UVA/UVB BROAD SPRECTRUM SPF 50+
50+
with
POWERSTAY
TECHNOLOGY
tear+sting free
High Endurance vs. Sweat & Water
Water Resistant
(80 Minutes)
7.5 FL.OZ. (221.8 mL)

Label

50%
MORE
FAMILY SIZE!
9 OZ VS 6 OZ
BANANA
BOAT
NEW
LOOK!
KiDS
SPORT
SUNSCREEN LOTION
UVA/UVB BROAD SPRECTRUM SPF 50+
50+
with
POWERSTAY
TECHNOLOGY
tear+sting free
High Endurance vs. Sweat & Water
Water Resistant
(80 Minutes)
9 FL.OZ. (270 mL)

Label

Label