Label: BANANA BOAT- avobenzone, octocrylene, oxybenzone stick
- NDC Code(s): 63354-140-61
- 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 January 13, 2022
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
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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 •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.
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Inactive ingredients
Petrolatum, Polyethylene, Ethylhexyl Palmitate,Trimethylsiloxyphenyl Dimethicone, Microcrystalline Wax, Isopropyl Myristate, Theobroma Cacao (Cocoa) Seed Butter, PEG-8, Caprylyl Glycol, Sodium Saccharin, Cocos Nucifera (Coconut) Oil, Mineral Oil, Aloe Barbadensis Leaf Extract, PEG-8 Dimethicone, Octyldodecanol, Retinyl Palmitate, Silica,Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Propylparaben, Butylparaben, Flavor
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INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, octocrylene, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-140 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) COCOA BUTTER (UNII: 512OYT1CRR) ISOSTEARYL MYRISTATE (UNII: H3VX9DDD0O) PETROLATUM (UNII: 4T6H12BN9U) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PEG-8 DIMETHICONE (UNII: GIA7T764OD) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLPARABEN (UNII: 3QPI1U3FV8) ASCORBIC ACID (UNII: PQ6CK8PD0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SACCHARIN SODIUM (UNII: SB8ZUX40TY) MINERAL OIL (UNII: T5L8T28FGP) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-140-61 4.25 g in 1 TUBE; Type 0: Not a Combination Product 08/26/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/26/2011 Labeler - Edgewell Personal Care Brands LLC (151179769)
