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| Product NDC Code | 61354-042 | ||||
|---|---|---|---|---|---|
| Drug Name | Moisturizer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | Oxygen Development LLC | ||||
| 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 ingredient Zinc Oxide 17%
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 generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. Reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease thsi risk, regulary use a sunscreen with a Board 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Cetearyl Olivate, Glyceryl Stearate Citrate, Stearyl/Octyldodecyl Citrate Crosspolymer, Dimethicone, Camellia Japonica Seed Oil, Glycolipids, Trehalose, Pullulan, Agastache Mexicana Flower/Leaf/Stem Extract, Camellia Oleifera Leaf Extract, Glycine, Alanine, Serine, Threonine, Chamomilla Recutita (Matricaria) Flower Extract, Leuconostoc/Radish Root Ferment Filtrate, Polylysine, Lecithin, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Hydrogenated Lecithin, Silica, Xanthan Gum, Cetearyl Alcohol, Tocopheryl Acetate, Mica, Tocopheryl, Sclerotium Gum, Glycerin, Caprylhydroxamic Acid, Titanium Dioxide (CI 77891) (090-50132-000)
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 protection. Higher SPF gives more sunburn protection. 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.Moisturizer Zinc Oxide COCO-CAPRYLATE/CAPRATE SORBITAN OLIVATE POLYGLYCERYL-3 STEARATE HYDROGENATED SOYBEAN LECITHIN SILICON DIOXIDE DIMETHICONE ISOSTEARIC ACID PROPANEDIOL POLYGLYCERYL-3 PENTARICINOLEATE GLYCERIN WATER ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER POLYHYDROXYSTEARIC ACID (2300 MW) GLYCERYL STEARATE CITRATE LECITHIN, SUNFLOWER CETEARYL OLIVATE GLYCERYL CAPRYLATE
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.61354-042-01_AW
61354-042-02_AW
61354-042-03_AW
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 Do not use on damage 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 the reach of children Keep out the 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 the protect 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 Stop use and ask a dosctor 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 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