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| Product NDC Code | 83119-243 | ||||
|---|---|---|---|---|---|
| Drug Name | Unid physical sun |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020.10 | ||||
| Labeler Name | Sage Pharmaceuticals Inc | ||||
| 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 Ingredients Titanium Dioxide 11.3%
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 an appropriate amount to the face and body prior to sun exposure, then pat lightly on the area. Reapply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients WATER, TRISILOXANE, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, COCO-CAPRYLATE/CAPRATE, GLYCERYL STEARATE CITRATE, PENTYLENE GLYCOL, DIMETHICONE, SILICON DIOXIDE, TREHALOSE, PROPANEDIOL, SODIUM ACRYLATES CROSSPOLYMER-2, 1,2-HEXANEDIOL, XANTHAN GUM, BUTYLENE GLYCOL, LECITHIN, SUNFLOWER, DISODIUM GLYCYRRHIZATE, CAPRYLHYDROXAMIC ACID, MEDICAGO SATIVA WHOLE
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 HVA / UVB protection Tear-free formula Paraben free Hypoallergenic Fragrance free
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.UNID Physical Sun Titanium Dioxide TITANIUM DIOXIDE TITANIUM DIOXIDE WATER TRISILOXANE PEG-6 CAPRYLIC/CAPRIC GLYCERIDES COCO-CAPRYLATE/CAPRATE GLYCERYL STEARATE CITRATE PENTYLENE GLYCOL DIMETHICONE SILICON DIOXIDE TREHALOSE PROPANEDIOL SODIUM ACRYLATES CROSSPOLYMER-2 1,2-HEXANEDIOL XANTHAN GUM BUTYLENE GLYCOL LECITHIN, SUNFLOWER DISODIUM GLYCYRRHIZATE CAPRYLHYDROXAMIC ACID MEDICAGO SATIVA WHOLE
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.image description
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.Sage Pharmaceuticals Inc Product of Taiwan Manufactured for IDAQS Biotech, Inc. Distributed by Beauty River International Inc. 901 S. Fremont Ave 108, Alhambra, CA 91803-4703, USA
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.
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.Avoid contact with eyes. In case of severe irritation, stop usage immediately and consult a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Storage Store in a cool, dry place away from heat and direct sunlight.
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.Cautions 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