Label: BANANA BOAT- avobenzone, homosalate, octocrylene lotion
- NDC Code(s): 67751-179-01
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 63354-890
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 15, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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
- Questions or Comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, homosalate, octocrylene lotionProduct 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)
