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Product NDC Code | 80641-009 | ||||
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Drug Name | Vacation spf 30 mineral |
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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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Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc Oxide 15.5%
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: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours • Sun Protection Measures. 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 including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol , Cucumis Sativus (Cucumber) Fruit Extract, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Glycerin, Glyceryl Behenate/Eicosadioate, Isododecane, Isopropyl Myristate, Magnesium Sulfate, Methyl Dihydroabietate, Niacinamide (Vitamin B3), Polyglyceryl-3 Oleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Sodium Gluconate, Tocopherol (Vitamin E), 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.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.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Vacation SPF 30 Mineral Zinc Oxide ISODODECANE MAGNESIUM SULFATE, UNSPECIFIED METHYL DIHYDROABIETATE POLYGLYCERYL-4 ISOSTEARATE PROPANEDIOL TOCOPHEROL XANTHAN GUM ALLANTOIN BUTYLOCTYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES CUCUMBER GLYCERIN SHEA BUTTER CETYL ALCOHOL WATER CAPRYLYL GLYCOL ZINC OXIDE ZINC OXIDE ALOE VERA LEAF ALKYL (C12-15) BENZOATE CAPRYLHYDROXAMIC ACID DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE GLYCERYL BEHENATE/EICOSADIOATE ISOPROPYL MYRISTATE NIACINAMIDE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE POLYGLYCERYL-3 OLEATE POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM GLUCONATE
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.1
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. In case of ingestion, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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.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
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