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| Product NDC Code | 58443-0452 | ||||||||
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| Drug Name | Panama jack broad spectrum spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Prime Enterprises Inc. | ||||||||
| 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 7.5% Octisalate 5% Octocrylene 5%
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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate, Ubiquinone, Water, Xanthan Gum
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.Panama Jack Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene CETYL ALCOHOL WATER SODIUM HYDROXIDE STEARYL ALCOHOL PHENOXYETHANOL ETHYLHEXYLGLYCERIN PROPYLENE GLYCOL UBIDECARENONE .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM EDETATE DISODIUM EDETIC ACID HIGH DENSITY POLYETHYLENE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALKYL (C12-15) BENZOATE DIMETHICONE GLYCERYL MONOSTEARATE GREEN TEA LEAF PEG-100 STEARATE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE
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.Panama Jack 30 Broad Spectrum SPF 30 Sunscreen Lotion Principle Display 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 • avoid contact with fabrics - could cause discoloration
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if rash occurs
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 toll free 1-800-840-5225
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 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