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| Product NDC Code | 79481-0025 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Meijer | ||||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.May stain or damage some fabrics or surfaces This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of Neutrogena Ultra Sheer Dry-Tough Sunscreen Broad Spectrum SPF 100+
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Avobenzone Homosalate Octisalate Octocrylene Purpose sunscreen
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 apply to all skin exposed to the sun reapply: after 80 minute of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your rist of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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 childre under 6 months of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, glyceryl stearate, PEG-100 stearate, beeswax, cyclopentasiloxane, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, chlorphenesin, benzyl alcohol, triethanolamine, disodium EDTA, BHT
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
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.SUNSCREEN Avobenzone, Homosalate, Octisalat, Octocrylene AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE Octisalate OCTISALATE OCTOCRYLENE OCTOCRYLENE water DIETHYLHEXYL 2,6-NAPHTHALATE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) SILICON DIOXIDE GLYCERYL MONOSTEARATE PEG-100 STEARATE YELLOW WAX CYCLOMETHICONE 5 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) CHLORPHENESIN benzyl alcohol TROLAMINE EDETATE DISODIUM ANHYDROUS BUTYLATED HYDROXYTOLUENE
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 meijer Compare to Neutrogena Ultra Sheer Sunscreen Broad Spectrum SPF 100+ sheer touch SUNSCREEN LOTION Broad Spectrum SPF 100 WATER RESISTANT (80 MINUTES) Clean, lightweight feel Dermatologist tested Quickly absorbs Non-greasy Oxybenzone & Octinoxate free 3 FL OZ (88mL) image description
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
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. In case of contact with the eyes, flush thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information protect the product in this container from excessive heat and dirtect sun
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-hands When using this product keep out of eyes. In case of contact with the eyes, flush thoroughly with water. 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