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| Product NDC Code | 79481-0914 | ||||||||
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| Drug Name | Sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Meijer Distribution, Inc | ||||||||
| 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.Adverse reactions section May stain or damage some favrics or surfaces *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30. **Ozybenzone & Octinoxate free Questions 1-888-593-0593 DISTRIBUTED BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com
Active ingredient
A list of the active, medicinal ingredients in the drug product.active ingredients Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 6%
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 liberaly 15 minutes before sun exposure apply to all skin exposed to the sun 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especialy from 10 a.m. -2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.inactive ingredients water, silica, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, glyceryl stearate, PEG-100 stearate, caprylyl methicone, cetyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, glycerin, pentylene glycol, acrylates/C12-22 alkyl methacrylate copolymer, ethylhexyl stearate, chlorphenesin, disodium EDTA, fragrance, diethylhexyl 2,6-naphthalate, BHT, trideceth-6
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.Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene WATER SILICON DIOXIDE DIMETHICONE POTASSIUM CETYL PHOSPHATE BENZYL ALCOHOL YELLOW WAX GLYCERYL MONOSTEARATE PEG-100 STEARATE CETYL DIMETHICONE 150 DIMETHICONE PEG-10 PHOSPHATE SODIUM POLYACRYLATE (8000 MW) DOCOSANOL XANTHAN GUM GLYCERIN PENTYLENE GLYCOL ALLYL METHACRYLATE ETHYLHEXYL STEARATE CHLORPHENESIN EDETATE DISODIUM ANHYDROUS DIETHYLHEXYL 2,6-NAPHTHALATE BUTYLATED HYDROXYTOLUENE TRIDECETH-6 AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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 Compare to Neutrogena Ultra Sheer Sunscreen Broad Spectrum SPF 30* meijer sheer touch SUNSCREEN LOTION Broad Spectrum SPF 30 WATER RESISTANT (80 MINUTES) Clean, Lightweight feel Dermatologist teste Quickly absorbs Non-greasy REEF FRIENDLY 3 FL OZ (88 mL) image description
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 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 the product in this container from excessive heat and direct sun
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
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