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 Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 1.8%

Homosalate 7.0%

Octocrylene 5.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out 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.

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.

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 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-sleeve shirts, pants, hats, and sunglasses.

• children under 6 months: Ask a doctor.

Inactive ingredients

water, cetearyl alcohol, stearyl alcohol, glycerin, phenoxyethanol, acrylates/c12-22 alkyl methacrylate copolymer, caprylyl glycol, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, methylparaben, xanthan gum, propylparaben, sodium hydroxide, disodium edta, hydrogenated methyl abietate, lauryl peg-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate copolymer, sodium ascorbyl phosphate, tocopheryl acetate, 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

INGREDIENTS AND APPEARANCE

BANANA BOAT 
avobenzone, homosalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-179(NDC:63354-890)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
COCO GLUCOSIDE (UNII: ICS790225B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-179-01	1 in 1 PACKAGE	12/04/2017
1		29 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/04/2017

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-179) , repack(67751-179)