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United spirit of america broad spectrum spf 50 sunscreen - Medication Information

Product NDC Code 58443-0496
Drug Name

United spirit of america broad spectrum spf 50 sunscreen

Type Brand
Active Ingredients
Titanium dioxide 45.5 mg/ml
Zinc oxide 39.6 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Prime Enterprises Inc.
Packages
Package NDC Code Description
58443-0496-3 88.7 ml in 1 tube (58443-0496-3)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Titanium Dioxide 4.5% Zinc Oxide 4%

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 this risk, regularly use a sunscreen with 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 sunglasses children under 6 months: Ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Allantoin, Aluminum Hydroxide, C12-15 Alkyl Benzoate, Camellia Oleifera (Green Tea) Leaf Extract, Caprylyl Glycol, Ceteareth-20, Cetyl Alcohol, Dibutyl Adipate, Glycerin, Hexyl Laurate, Magnesium Aluminum Silicate, Methylcellulose, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Polyglyceryl-3 Distearate, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, VP/Eicosene Copolymer, 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.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
United Spirit of America Broad Spectrum SPF 50 Sunscreen Titanium Dioxide, Zinc Oxide STEARIC ACID TRIETHOXYCAPRYLYLSILANE CAPRYLYL GLYCOL PHENOXYETHANOL CETYL ALCOHOL DIBUTYL ADIPATE METHYLCELLULOSE (15 CPS) OCTYLDODECYL CITRATE CROSSPOLYMER POLYGLYCERYL-3 DISTEARATE ALLANTOIN STEARYL ALCOHOL VINYLPYRROLIDONE/EICOSENE COPOLYMER XANTHAN GUM ALUMINUM HYDROXIDE POLYOXYL 20 CETOSTEARYL ETHER HEXYL LAURATE MAGNESIUM ALUMINUM SILICATE GLYCERIN GREEN TEA LEAF ALKYL (C12-15) BENZOATE WATER TITANIUM DIOXIDE TITANIUM DIOXIDE 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.
United Spirit of America Warrior Broad Spectrum SPF 50 Sunscreen Lotion Principal Display Label

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Stop use and ask a doctor if rash occurs

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.

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

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.

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 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