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| Product NDC Code | 58274-011 | ||||
|---|---|---|---|---|---|
| Drug Name | Brush on block mineral powder sunscreen translucent |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | POWDER | ||||
| Application Number | part352 | ||||
| Labeler Name | SPF Ventures, 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 Ingredients Titanium Dioxide 6% Zinc Oxide 21%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Bisabolol, Boron Nitride, Chamomile Flower Extract, Ethyl Ferulate, Hydroxyacetophenone, Iron Oxides, Lauroyl Lysine, Mica, Phenyl Trimethicone, Rice Bran Extract, Safflower Seed Oil, Silica, Sodium Dehydroacetate, Triethoxycaprylylsilane.
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 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.Brush on Block Mineral Powder Sunscreen Translucent Titanium Dioxide, Zinc Oxide ZINC OXIDE ZINC CATION LAUROYL LYSINE SODIUM DEHYDROACETATE TRIETHOXYCAPRYLYLSILANE LEVOMENOL ETHYL FERULATE MICA PHENYL TRIMETHICONE SILICON DIOXIDE HYDROXYACETOPHENONE FERRIC OXIDE RED RICE BRAN OIL BORON NITRIDE SAFFLOWER OIL CHAMOMILE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.label
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.
Instructions for use
Information about safe handling and use of the drug product.Directions Apply liberally 15 minutes before sun exposure 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10am - 2pm • Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor
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. Keep out of reach of children. If product is 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 product in this container from excessive heat and direct sun.
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? Contact our specialists at (800) 916-7690
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 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. Do not use Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor Stop use and ask a doctor if rash occurs. Keep out of reach of children. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
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