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Banana boat protection plus vitamins sunscreen uva/uvb broad spectrum spf 50 - Medication Information

Product NDC Code 63354-571
Drug Name

Banana boat protection plus vitamins sunscreen uva/uvb broad spectrum spf 50

Type Brand
Active Ingredients
Avobenzone 2.7 g/100g
Homosalate 9 g/100g
Octisalate 4 g/100g
Octocrylene 5 g/100g
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Edgewell Personal Care Brands LLC
Packages
Package NDC Code Description
63354-571-23 133 g in 1 tube (63354-571-23)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

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 • 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 Ingredients Water, Diisopropyl Adipate, Niacinamide, Cetearyl Alcohol, Phenoxyethanol, Carbomer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Ascorbyl Glucoside, Glycerin, Chlorphenesin, Dicetyl Phosphate, Ceteth-10 Phosphate, Coco Glucoside, Sodium Hydroxide, Propylene Glycol, Cocos Nucifera (Coconut) Oil, Xanthan Gum, Disodium EDTA, Camellia Sinensis Leaf Extract, Fragrance, Mica, Tocopheryl Acetate, Titanium Dioxide, Iron Oxides.

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 Agent

Spl product data elements

Usually a list of ingredients in a drug product.
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE EDETATE DISODIUM ANHYDROUS NIACINAMIDE PROPYLENE GLYCOL CETETH-10 PHOSPHATE DIHEXADECYL PHOSPHATE GLYCERIN ASCORBYL GLUCOSIDE PHENOXYETHANOL OCTISALATE OCTISALATE GREEN TEA LEAF CETOSTEARYL ALCOHOL DIISOPROPYL ADIPATE WATER TITANIUM DIOXIDE MICA BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE OCTOCRYLENE OCTOCRYLENE CHLORPHENESIN ALPHA-TOCOPHEROL ACETATE XANTHAN GUM COCONUT OIL SODIUM HYDROXIDE COCO GLUCOSIDE

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.
PRINCIPAL DISPLAY PANEL BANANA BOAT NEW! PROTECTION +VITAMINS SUNSCREEN LOTION UVA/UVB BROAD SPECTRUM SPF 50+ 50+ VITAMINS C+ B3 12 HOUR HYDRATION NOURISH + PROTECT FROM UV DAMAGE Water Resistant (80 Minutes) 4.5 FL. 0Z (133 mL) label

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 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. May stain some fabrics and surfaces Do not use on damaged or broken skin. When using this product 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