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| Product NDC Code | 71585-141 | ||||
|---|---|---|---|---|---|
| Drug Name | Salt and stone spf 30 sunscreen stick |
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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 | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | Salt and Stone | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide (Non-Nano) 22.5% Purpose Sunscreen
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 two (2) hours. Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease the risk, regularly use: a suscreen with a broad-spectrum measures including: Sun Protection Measures Limiting time in the sun, especially from 10AM - 2PM. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients (Shea) Butter, Cera Alba (Beeswax)*, (Carnauba) Wax,* (Coconut) Oil,* (Sunflower) Seed Oil,* Butyrospermum Parkii Copernicia Cerifera Cocos Nucifera Helianthus Annuus Mica, Silica, Simmondsia Chinensis (Jojoba) Seed Oil,* Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate. *Organic Ingredient
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 Hepls 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.Salt and Stone SPF 30 Sunscreen stick ZINC OXIDE SHEA BUTTER YELLOW WAX CARNAUBA WAX COCONUT OIL SUNFLOWER OIL MICA SILICON DIOXIDE JOJOBA OIL COCOA BUTTER .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC CATION
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.Package Labeling: Outer Package2 Inner Package2
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Other Information Protect this product from excess heat and direct sun.
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 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 see a doctor.
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. If rash occurs
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 on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove. If rash occurs stop use and see a doctor. 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