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| Product NDC Code | 58443-0364 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Everyman jack spf 50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Prime Enterprises | ||||||||
| 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 Ingredient Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocryle 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 and 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 the 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. to 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 Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Cetyl Alcohol, Cetyl Phosphate, Ethylhexylglycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, PEG-100 Stearate, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Propylene Glycol, Silica, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium Glutamate Diacetate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water
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.Everyman Jack SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene ALPHA-TOCOPHEROL ACETATE WATER PEG-100 STEARATE GLYCERYL MONOSTEARATE PHENYL TRIMETHICONE OCTOCRYLENE OCTOCRYLENE CARBOMER INTERPOLYMER TYPE A (55000 CPS) ALOE VERA LEAF SHEA BUTTER CETYL ALCOHOL AVOBENZONE AVOBENZONE COCOA BUTTER GLYCYRRHIZA GLABRA PROPYLENE GLYCOL SILICON DIOXIDE OCTISALATE OCTISALATE STEARYL ALCOHOL SODIUM HYDROXIDE PHENOXYETHANOL CETYL PHOSPHATE HIGH DENSITY POLYETHYLENE ETHYLHEXYLGLYCERIN TETRASODIUM GLUTAMATE DIACETATE HOMOSALATE HOMOSALATE off white
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.Every Man Jack Face Shield Sun Protection Lotion SPF 50 Principal Display Label
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 swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Ohter 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 877-875-5225, 9-5 PST weekdays.
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 wih 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 wih water to remove. Stop use and ask a doctor If rash occurs Keep out of reach of children If 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