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| Product NDC Code | 63354-410 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Banana boat |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OIL | ||||||||
| 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 3.0%, Homosalate 4.5%, Octisalate 3.2%, Octocrylene 2.4%
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 Apply liberally 15 minutes before sun exposure; • Do not spray directly into face . Spray on hands and then apply to face. •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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Mineral Oil, C12-15 Alkyl Benzoate, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Isopropyl Myristate, Coconut Oil, Grape Seed Oil, Theobroma Cacao (Cocoa) Seed Butter (Cocoa Butter),Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Zea Mays (Corn) Oil, Aloe Barbadensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract,Phenoxyethanol, Fragrance.
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
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 HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE MINERAL OIL CAPRYLYL GLYCOL DIETHYLHEXYL 2,6-NAPHTHALATE ISOPROPYL MYRISTATE COCONUT OIL GRAPE SEED OIL THEOBROMA CACAO WHOLE .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF SUNFLOWER OIL CORN OIL CARROT BANANA PHENOXYETHANOL AVOBENZONE AVOBENZONE
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® TANNING SPRAY OIL SUNSCREEN SPRAY SPF 8 8 WITH COCONUT OIL Skin Nourishing Formula Water Resistant (80 Minutes) 8 FL. OZ. (236 mL) BANANA BOAT Spray Oil UVA/UVB PROTECTION SUNSCREEN 8 BROAD SPECTRUM SPF 8 CARROT & BANANA EXTRACTS WATER RESISTANT (80 MINUTES) SWIM SPLASH SPORT X001008801 Front label X001008801 Back label 6335441016
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 & 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 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 Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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