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Product NDC Code | 41250-921 | ||||||||
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Drug Name | Meijer baby tear free spf 50 cs |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | SPRAY | ||||||||
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 10.0%, Octisalate 5.0%, Octocrylene 6.0%
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 hold container 4-6 inches from the skin to apply spray liberally and spread evenly by hand 15 minutes before sun exposure Do not spray directly on face . Spray on hands then apply to face. do not apply in windy conditions use in well-ventilated area 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 a broad spectrum SPF 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 of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Isobutane, Water, Isohexadecane, Ethylhexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Dibutyl Adipate, Lauryl PEG-8 Dimethicone, Ethylhexyl Methoxycrylene, Sodium Chloride, PEG-8, Caprylyl Glycol, Glycerin, Sodium Citrate, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben.
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 Baby Tear Free SPF 50 CS Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE ISOBUTANE WATER ISOHEXADECANE 2-ETHYLHEXYL BENZOATE DIBUTYL ADIPATE ETHYLHEXYL METHOXYCRYLENE SODIUM CHLORIDE POLYETHYLENE GLYCOL 400 CAPRYLYL GLYCOL GLYCERIN SODIUM CITRATE, UNSPECIFIED FORM PEG-8 DIMETHICONE ALOE VERA LEAF OCTYLDODECANOL VITAMIN A PALMITATE SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA PHENOXYETHANOL METHYLPARABEN ISOBUTYLPARABEN PROPYLPARABEN
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.Principle Display Label NDC: 41250-921-55 meijer tear free baby Sunscreen continuous spray pediatrician tested UVA/UVB protection 50+ Broad Spectrum SPF 50+ Water Resistant (80 minutes) Net Wt 6 OZ. (170 g) 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
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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. May stain some fabrics
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 1-800-697-9868 Mon-Fri
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 away from face to avoid breathing it 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 Flammable: Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 o F. Do not use in the presence of a flame or spark. Keep away from sources of ignition-No smoking. Do not use on damaged or broken skin When using this product Keep away from face to avoid breathing it 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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. May stain some fabrics
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