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| Product NDC Code | 41250-561 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Meijer broad spectrum spf 50 sunscreen |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| Application Number | part352 | ||||||||||
| Labeler Name | MEIJER DISTRIBUTION, INC. | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3.0% Homosalate 13.0% Octisalate 5.0% Octocrylene 7.0% Oxybenzone 4.0%
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 • children under 6 months of age: ask a doctor • 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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, stearic acid, triethanolamine, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, fragrance, methylparaben, carbomer, propylparaben, disodium EDTA
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.MEIJER BROAD SPECTRUM SPF 50 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE WATER SORBITOL STEARIC ACID ALUMINUM STARCH OCTENYLSUCCINATE POLYETHYLOXAZOLINE (200000 MW) CARBOMER 934 DIMETHICONE TOCOPHEROL EDETATE DISODIUM EDETIC ACID POLYGLYCERYL-3 DISTEARATE PHENOXYETHANOL ETHYLHEXYLGLYCERIN SORBITAN ISOSTEARATE BENZYL ALCOHOL TROLAMINE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE PROPYLPARABEN OXYBENZONE OXYBENZONE EICOSYL POVIDONE METHYLPARABEN
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.MEIJER BROAD SPECTRUM SPF 50 SUNSCREEN LOTION 8 FL OZ (237mL) NDC 41250-561-11 Label
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.Other information • protect this product from excessive heat and direct sun • may stain or damage some fabrics/materials or surfaces
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 1-800-527-7731
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.
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
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