Label: BANANA BOAT- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 63354-039-31, 63354-039-34, 63354-039-37
- Packager: Edgewell Personal Care Brands, LLC
- 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 November 21, 2022
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- Active Ingredient
- Purpose
- Uses
- Warnings
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Flammable
Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F. Do not use in the presence of a flame or spark. Keep away from sources of ignition – No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- May stain
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Directions
Shake well. Hold container 4 to 6 inches from the skin to apply. Spray liberally and spread evenly by hand 15 minutes before sun exposure. Do not spray directly into face. Spray on hands and then apply to face. Do not apply in windy conditions. Use in a well-ventilated area. Reapply: • after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months: Ask a doctor. 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 - Inactive Ingredients
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INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-039 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 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 Inactive Ingredients Ingredient Name Strength MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) ISOBUTANE (UNII: BXR49TP611) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) ISOHEXADECANE (UNII: 918X1OUF1E) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-039-31 51 g in 1 CAN; Type 0: Not a Combination Product 10/15/2018 2 NDC:63354-039-34 170 g in 1 CAN; Type 0: Not a Combination Product 10/15/2018 3 NDC:63354-039-37 269 g in 1 CAN; Type 0: Not a Combination Product 10/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/15/2018 Labeler - Edgewell Personal Care Brands, LLC (151179769)
