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| Product NDC Code | 63354-724 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Banana boat |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | AEROSOL | ||||||||||
| Application Number | part352 | ||||||||||
| Labeler Name | Edgewell Personal Care Brands LLC | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%, Oxybenzone 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 ■ 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-sleeve 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 Ingredients Alcohol Denat., Isobutane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Caprylyl Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Fragrance, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Ascorbyl Palmitate, Hydrogenated Methyl Abietate, Tocopheryl Acetate, Mineral Oil, Panthenol, Water, Aloe Barbadensis Leaf Extract.
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 Directions ), decreases 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, OXYBENZONE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE ALCOHOL DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE OCTOCRYLENE OCTOCRYLENE DIMETHICONE PEG-8 LAURATE ASCORBYL PALMITATE METHYL DIHYDROABIETATE .ALPHA.-TOCOPHEROL ACETATE MINERAL OIL PANTHENOL WATER ALOE VERA LEAF AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE ISOBUTANE CAPRYLYL GLYCOL CYCLOMETHICONE 5 CYCLOMETHICONE 6
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 (R) Ultra Defense (R) CLEAR SUNSCREEN SPRAY UVA/UVB BROAD SPECTRUM SPF 100 100 PROTECTS AGAINST 99% OF BURNING RAYS LIGHTWEIGHT High Endurance vs. Water Water Resistant (80 Minutes) NET WT 6 OZ. (170 g) CLEAR UltraMist BANANA BOAT Ultra Defense MAX Skin Protect UVA/UVB PROTECTION CONTINUOUS SPRAY SUNSCREEN 100 BROAD SPECTRUM SPF 100 WATER RESISTANT (80 MINUTES) LIGHTWEIGHT & HYDRATING VITAMIN E PROTECTS AGAINST 99% OF BURNING RAYS SWIM SPLASH SPORT 63354-724-34 6335472434
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. May stain some fabrics.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Protect this product from excessive heat and direct sun
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.
Safe handling warning
Safe Handling WarningFlammable Contents under pressure. Do not puncture or incinerate container. 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.
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
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