Label: BANANA BOAT- avobenzone, homosalate, octocrylene spray
- NDC Code(s): 63354-379-34
- Packager: Edgewell Personal Care Brands LLC
- Category: HUMAN OTC DRUG LABEL
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 June 17, 2019
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- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Flammable
Contents under pressure. Do not puncture or incinerate. 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.
- 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. • Do not apply in windy conditions • Use in 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, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-379 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALCOHOL (UNII: 3K9958V90M) ISODODECANE (UNII: A8289P68Y2) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-379-34 170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 06/17/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/17/2019 Labeler - Edgewell Personal Care Brands LLC (151179769)
