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Product NDC Code | 58274-012 | ||||
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Drug Name | Brush on block quick stick spf 40 mineral stick |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | STICK | ||||
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 17.5%
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 at least every 2 hours use a water resistant sunscreen if swimming or sweating Children under 6 months of age: Ask a doctor. Sunprotection 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients C12-15 ALKYL BENZOATE CAPRYLIC/CAPRIC TRIGLYCERIDE HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX ISOSTEARYL ISOSTEARATE BUTYLOCTYL SALICYLATE TRIBEHENIN DIISOSTEARYL MALATE SILICA OCTYLDODECANOL CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL POLYHYDROXYSTEARIC ACID STEARALKONIUM BENTONITE CALCIUM ALUMINUM BOROSILICATE CAPRYLYL GLYCOL ETHYLHEXYL PALMITATE GLUCOMANNAN GLYCINE SOJA (SOYBEAN) OIL HESPERETHUSA CRENULATA BARK EXTRACT ISOSTEARIC ACID LECITHIN MALIC ACID ORYZA SATIVA (RICE) EXTRACT ORYZA SATIVA (RICE) GERM EXTRACT POLYGLYCERYL-3 DIISOSTEARATE POLYGLYCERYL-3 POLYRICINOLEATE PROPYLENE CARBONATE SODIUM HYALURONATE TOCOPHEROL TRIHYDROXYSTEARIN
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 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 Quick Stick SPF 40 Mineral Stick zinc oxide HYALURONATE SODIUM TRIHYDROXYSTEARIN ISOSTEARYL ISOSTEARATE RICE GERM ZINC OXIDE ZINC OXIDE ALKYL (C12-15) BENZOATE POLYHYDROXYSTEARIC ACID (2300 MW) SOYBEAN OIL MALIC ACID POLYGLYCERYL-3 PENTARICINOLEATE PROPYLENE CARBONATE TOCOPHEROL OCTYLDODECANOL HELIANTHUS ANNUUS SEED WAX SAFFLOWER OIL CALCIUM ALUMINUM BOROSILICATE CAPRYLYL GLYCOL NARINGI CRENULATA WHOLE MEDIUM-CHAIN TRIGLYCERIDES DIISOSTEARYL MALATE SILICON DIOXIDE ETHYLHEXYL PALMITATE KONJAC MANNAN TRIBEHENIN BUTYLOCTYL SALICYLATE ISOSTEARIC ACID POLYGLYCERYL-3 DIISOSTEARATE LECITHIN, SUNFLOWER STEARALKONIUM HECTORITE
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 this product 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 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 this product 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 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