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| Product NDC Code | 69555-043 | ||||
|---|---|---|---|---|---|
| Drug Name | Allswell mineral sunscreen 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 | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | Stream2Sea, 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 ingredient Zinc Oxide 22%
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 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-sleeve 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 Helianthus Annus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Caprylic Capric Triglycerides, Butyrospermum Parkii (Shea) Butter, Beeswax, Helianthus Annus (Sunflower) Seed Wax, Polyhydroxystearic Acid, Glyceryl Caprylate (and) Glyceryl Undecylenate, Non-GMO Corn Starch, Acrylates Copolymer, Vitamin E
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.ALLSWELL MINERAL SUNSCREEN SPF 30 Zinc Oxide SUNFLOWER OIL AVOCADO OIL MEDIUM-CHAIN TRIGLYCERIDES SHEA BUTTER YELLOW WAX HELIANTHUS ANNUUS SEED WAX POLYHYDROXYSTEARIC ACID (2300 MW) GLYCERYL CAPRYLATE GLYCERYL 1-UNDECYLENATE STARCH, CORN BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) .ALPHA.-TOCOPHEROL 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.Allswell Mineral Sunscreen Spf 30-NDC 69555-043-01-Tube label image description image description
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? Visit allswellgoods.com
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect this product 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 on damaged or broken skin. When using this product , keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product 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