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Product NDC Code | 80325-000 | ||||
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Drug Name | Spit and polish mineral face spf 30 |
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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 | Naturally Uncommon, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 22% 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 15 minutes prior to sun exposure. Reapply every 80 minutes when subject to prolonged sweating or water exposure. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures. Sun protection measures:
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Helianthus Annus (Sunflower) Oil, Cocos Nucifera (Coconut) Oil, Cera Alba, Butyrospermum Parkii (Shea Butter), Silica, Copernicia Cerifera (Carnauba) Wax, Theobroma Cacao (Cocoa) Butter, Simmondsia Chinensis (Jojoba) Oil, DL-Alpha-Tocopheryl Acetate.
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, 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.Spit and Polish Mineral Face SPF 30 ZINC OXIDE HELIANTHUS ANNUUS FLOWERING TOP COCONUT OIL WHITE WAX SHEA BUTTER SILICON DIOXIDE CARNAUBA WAX COCOA JOJOBA OIL .ALPHA.-TOCOPHEROL ACETATE, DL- 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: Bottle3
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: Store between 40 ° and 80 ° F
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. For use with children under 6 months of age consult a doctor.
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 immediately and consult your physician.
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: Do not apply directly to eyes and if irritation occurs flush with water only. If redness or irritation occurs after application, Stop use immediately and consult your physician. Keep out of reach of children. For use with children under 6 months of age consult a doctor.
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