BANANA BOAT- avobenzone, homosalate, octisalate, octocrylene lotion

Banana Boat by

Drug Labeling and Warnings

Banana Boat by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC, Playtex Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.0%
Homosalate 9.0%
Octisalate 4.0%
Octocrylene 5.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses.

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Keep away from face to avoid breathing it. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

May stain some fabrics

Directions

Apply liberally 15 minutes before sun exposure Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Children under 6 months: Ask a doctor

Inactive Ingredients

Water, Diisopropyl Adipate, Silica, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Tapioca Starch, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Methylparaben, Fragrance, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Polymethylsilsesquioxane, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice.

Other Information

Protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-SAFESUN, Mon-Fri

Principal Display Panel

Banana

Boat

Dry

Balance

Sunscreen Lotion

helps you feel

dry & fresh

50+

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50+

SOFT MATTE FINISH

SKIN BREATHES EASY

WATER RESISTANT

(80 MINUTES)

INGREDIENTS AND APPEARANCE

BANANA BOAT 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-757
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
METHYLPARABEN (UNII: A2I8C7HI9T)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STARCH, TAPIOCA (UNII: 24SC3U704I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO GLUCOSIDE (UNII: ICS790225B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-757-54	177 g in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2017
2	NDC: 63354-757-56	221 g in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2017	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2017

Labeler - Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing Inc		963501502	manufacture(63354-757)