Label: BANANA BOAT- avobenzone, homosalate, octocrylene, oxybenzone oil
- NDC Code(s): 63354-220-34
- 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 December 5, 2018
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- ACTIVE INGREDIENT
- Purpose
- Uses
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Warnings
For external use only.
Flammable: Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 oF. 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 on damaged or broken skin.
- 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 then apply to 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
- 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
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Inactive Ingredients
Alcohol Denat., Mineral Oil, C12-15 Alkyl Lactate, Ethylhexyl Benzoate, Trimethylolpropane Tricaprylate/Tricaprate, Acrylates/Octylacrylamide Copolymer, Cetearyl Ethylhexanoate, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Caprylyl Glycol, Dimethyl Capramide, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Fragrance.
- Other Information
- Questions or comments?
- Principle Display Panel
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INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, homosalate, octocrylene, oxybenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) MINERAL OIL (UNII: T5L8T28FGP) C12-15 ALKYL LACTATE (UNII: GC844VRD7E) 2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13) TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) COCONUT OIL (UNII: Q9L0O73W7L) GRAPE SEED OIL (UNII: 930MLC8XGG) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-220-34 177 g in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/19/2012 Labeler - Edgewell Personal Care Brands LLC (151179769)
