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| Product NDC Code | 63354-278 | ||||||||||||||
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| Drug Name | Banana boat |
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| Type | Brand | ||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||
| Dosage Form | SPRAY | ||||||||||||||
| Application Number | M020 | ||||||||||||||
| Labeler Name | Edgewell Personal Care Brands, LLC | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 6%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 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 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. Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Water, Isobutane, Isohexadecane, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Dibutyl Adipate, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Phenoxyethanol, Caprylyl Glycol, Glycerin, Sodium Citrate, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Direction ), decrease the risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene ISOHEXADECANE ALKYL (C12-15) BENZOATE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) ALOE VERA LEAF VITAMIN A PALMITATE ASCORBIC ACID SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA SODIUM CITRATE METHYLPARABEN ETHYLPARABEN BUTYLPARABEN ISOBUTYLPARABEN METHYL DIHYDROABIETATE PEG-8 DIMETHICONE OCTYLDODECANOL .ALPHA.-TOCOPHEROL ACETATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE WATER ISOBUTANE OCTISALATE OCTISALATE SODIUM CHLORIDE POLYETHYLENE GLYCOL 400 OCTOCRYLENE OCTOCRYLENE CAPRYLYL GLYCOL PROPYLPARABEN SILICON DIOXIDE DIBUTYL ADIPATE ETHYLHEXYL METHOXYCRYLENE PHENOXYETHANOL GLYCERIN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.BANANA BOAT® KiDS SPORT SUNSCREEN LOTION SPRAY UVA/UVB BROAD SPECTRUM SPF50+ 50+ with POWERSTAY TECHNOLOGY tear+sting free High Endurance vs. Sweat & Water Water Resistant (80 Minutes) SHAKE WELL BEFORE USE NET WT 1.8 OZ. (51 g) BANANA BOAT® KiDS SPORT SUNSCREEN LOTION SPRAY UVA/UVB BROAD SPECTRUM SPF50+ 50+ with POWERSTAY TECHNOLOGY tear+sting free High Endurance vs. Sweat & Water Water Resistant (80 Minutes) SHAKE WELL BEFORE USE NET WT 6 OZ. (170 g) BONUS 33% MORE 8 OZ VS 6 OZ BANANA BOAT® KiDS SPORT SUNSCREEN LOTION SPRAY UVA/UVB BROAD SPECTRUM SPF50+ 50+ with POWERSTAY TECHNOLOGY tear+sting free High Endurance vs. Sweat & Water Water Resistant (80 Minutes) SHAKE WELL BEFORE USE NET WT 8 OZ. (227 g) 55% MORE FAMILY SIZE! 9.5 OZ VS 6 OZ BANANA BOAT® KiDS SPORT SUNSCREEN LOTION SPRAY UVA/UVB BROAD SPECTRUM SPF50+ 50+ with POWERSTAY TECHNOLOGY tear+sting free High Endurance vs. Sweat & Water Water Resistant (80 Minutes) SHAKE WELL BEFORE USE NET WT 9.5 OZ. (269 g) BANANA BOAT® KiDS SPORT SUNSCREEN LOTION SPRAY UVA/UVB BROAD SPECTRUM SPF50+ 50+ with POWERSTAY TECHNOLOGY tear+sting free High Endurance vs. Sweat & Water Water Resistant (80 Minutes) SHAKE WELL BEFORE USE 2-6 OZ. (170 g) CANS TOTAL NET WT 12 OZ. (340 g) BANANA BOAT® TEAR + STING FREE PEDIATRICIAN TESTED LIGHTWEIGHT QUICK ABSORBING HIGH ENDURANCE VS. SWEAT & WATER LASTS AS LONG AS THE FUN DOES FREE FROM Oxybenzone Octinoxate 2 - 9.5 OZ. Kids Sport SPF 50+ Sunscreen Lotion Spray Total Net WT 19 OZ. (538 g) Label Label Label Label Label Front card Back card
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information • protect this product from excessive heat and direct sun.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-800-SafeSun, Mon-Fri
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • Keep away from face to avoid breathing it • keep out of eyes. Rinse with water to remove.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 some fabrics. Do not use on damaged or broken skin. When using this product • Keep away from face to avoid breathing it • keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API