Label: BANANA BOAT- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 63354-925-31, 63354-925-34, 63354-925-36, 63354-925-37
- 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 22, 2022
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- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
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.
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
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Directions
•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
- 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:63354-925 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SODIUM CITRATE (UNII: 1Q73Q2JULR) ISOBUTANE (UNII: BXR49TP611) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) ISOHEXADECANE (UNII: 918X1OUF1E) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-925-34 170 g in 1 CAN; Type 0: Not a Combination Product 01/02/2018 2 NDC:63354-925-31 51 g in 1 CAN; Type 0: Not a Combination Product 01/02/2018 3 NDC:63354-925-37 269 g in 1 CAN; Type 0: Not a Combination Product 01/02/2018 4 NDC:63354-925-36 212 g in 1 CAN; Type 0: Not a Combination Product 04/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/02/2018 Labeler - Edgewell Personal Care Brands, LLC (151179769) Establishment Name Address ID/FEI Business Operations KIK Custom Product 243547333 manufacture(63354-925)
