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| Product NDC Code | 61354-052 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Powder |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | POWDER | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Oxygen development | ||||||||
| 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 8.6 zinc Oxide 10.0
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 Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. reapply at lease every 2 hours. Children under 6 months: ask a doctor. optional: apply toall skin exposed to the sun. Sun Protection measures. spending time in the sin increases your risk ofg skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m-2p.m. Wear long-sleeved shirts, pants, hats and sunglasses.
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 again 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.powder Zinc Oxide, Titanium Dioxide JOJOBA OIL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) TITANIUM DIOXIDE TITANIUM DIOXIDE SILICON DIOXIDE ZINC OXIDE ZINC OXIDE
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.Primary package 61354-052_AW 61354-052_AW 61354-052_AW
Secondary Package 61354-052-01_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 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 the reach of children If swallowed, get medical help or contact a Poison Control center rigth 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 Stop use and ask 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 When using this product keep out of eyes. Rinse with water to remove
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 direct sunlight. You may report a serious adverse reaction to: tarte c/o report Reaction, LLC,P.O.Box 22,Plainsboro, New Jersey 08536-0222.
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