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Product NDC Code | 58274-020 | ||||
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Drug Name | Brush on block spf 30 mineral powder translucent zinc only |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | POWDER | ||||
Application Number | M020 | ||||
Labeler Name | SPF Ventures, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 22.1%
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 Reapply: After 80 minutes of swimming or sweating; Immediately after towel drying; At least every 2 hours Sun Proection Measures: Spending time in the sun increases yur 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 of age: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Sodium hyaluronate Niacinimide Mica Lauroyl lysine Boron nitride Silica Triethoxycaprylylsilane Ethyl ferulate Oryza sativa (rice) bran extract Iron oxides Bisabolol Squalane Simmondsia chinensis (jojoba) seed oil Tetrahexyldecyl ascorbate Sclerocarya birrea seed oil Glyceryl caprylate Glycerin Caprylhydroxamic acid
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 cance 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.Brush On Block SPF 30 Mineral Powder Translucent Zinc Only Zinc oxide LEVOMENOL CAPRYLHYDROXAMIC ACID ETHYL FERULATE JOJOBA OIL ZINC OXIDE ZINC OXIDE RICE BRAN NIACINAMIDE TETRAHEXYLDECYL ASCORBATE GLYCERYL CAPRYLATE GLYCERIN BORON NITRIDE SQUALANE TRIETHOXYCAPRYLYLSILANE MICA LAUROYL LYSINE FERRIC OXIDE YELLOW SILICON DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED HYALURONATE SODIUM SCLEROCARYA BIRREA SEED OIL
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 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.
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.
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 thi sproduct When using this product keeo 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 sun.
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 thi sproduct When using this product keeo 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 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