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| Product NDC Code | 80641-014 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mineral shake |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | M020 | ||||||
| Labeler Name | Vacation Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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.Dosage and administration Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactives Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP Cholesterol, Cucumis Sativus (Cucumber) Fruit Extract, Dihydro Myrcenol, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Dimethicone, Ethylhexyl Methoxycrylene, Ethylhexyl Olivate, Ethylhexylglycerin, Ferulic Acid, Floralozone, Glycerin, Gossypium Herbaceum (Cotton) Seed Oil, Hexyl Cinnamic Aldehyde, Hyaluronic Acid, Isododecane, Magnesium Sulfate, Methyl Octyne Carbonate, Niacinamide, Passiflora Edulis Seed Oil, Phenoxyethanol, Phytosphingosine, Polyglyceryl-3 Oleate Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Scentenal, Sodium Benzoate, Sodium Gluconate, Sodium Lauroyl Lactylate, Squalane, sr-Hydrozoan Polypeptide-1, Tocopherol, Triethoxycaprylylsilane Undecavertol, Water, Xanthan Gum
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.Indications and Usage 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.Mineral Shake Zinc Oxide BUTYLOCTYL SALICYLATE ZINC OXIDE ZINC OXIDE
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.Vacation SPF 50 Mineral Shake Mineral Shake
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 Keep out of reach of children
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. Rinsed with water to remove. Stop use and ask a doctor is rash occurs
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