BANANA BOAT- avobenzone, homosalate, octocrylene lotion 
Navajo Manufacturing Company Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Banana Boat

Drug Facts

Active Ingredients

Avobenzone 1.8%

Homosalate 7.0%

Octocrylene 5.0%

Purpose

Sunscreen

Uses

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

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:

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

Questions or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

Banana Boat

BANANA BOAT 
avobenzone, homosalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-179(NDC:63354-890)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-179-011 in 1 PACKAGE12/04/2017
129 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/04/2017
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-179) , repack(67751-179)

Revised: 3/2023
Document Id: f6f75dbf-57d5-f769-e053-6394a90ad5b3
Set id: 60b42298-c556-534b-e053-2a91aa0a881b
Version: 3
Effective Time: 20230315
 
Navajo Manufacturing Company Inc.