BANANA BOAT- avobenzone homosalate 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 5.0%, Octocrylene 4.0%

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.

D o not use

on damaged or broken skin

When using this product

Keep out of eyes. 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.

OTHER SAFETY INFORMATION

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, Ethylhexyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethylsilsesquioxane, Silica, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Dimethicone, Glycerin, Carbomer, Fragrance, Coco- Glucoside, Methylparaben, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylparaben, Sodium Hydroxide, Disodium EDTA, Paraffin, Xanthan Gum, 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

PDP

BANANA BOAT

SunComfort

Sunscreen Lotion

Sand easily brushes off/ Relieves dryness

UVA/UVB PROTECTION

BROAD PECTRUM SPF 30

GOOD FOR EVERYDAY US

LIGHTWEIGHT

WATER RESISTANT

(80 MINUTES)

SWIM SPLASH SPORT

INGREDIENTS AND APPEARANCE

BANANA BOAT 
avobenzone homosalate octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-795
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 934 (UNII: Z135WT9208)
COCO GLUCOSIDE (UNII: ICS790225B)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PARAFFIN (UNII: I9O0E3H2ZE)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENETHYL BENZOATE (UNII: 0C143929GK)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-795-21	29 g in 1 TUBE; Type 0: Not a Combination Product	10/15/2015
2	NDC: 63354-795-54	177 g in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2015
3	NDC: 63354-795-56	221 g in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2015	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/15/2015

Labeler - Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing Inc.		963501502	manufacture(63354-795)