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Biosolis face sunscreen broadspectrum spf50 - Medication Information

Product NDC Code 61296-017
Drug Name

Biosolis face sunscreen broadspectrum spf50

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Titanium dioxide 100 mg/ml
Zinc oxide 152 mg/ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Pro Vera SA
Packages
Package NDC Code Description
61296-017-00 1 bottle, pump in 1 box (61296-017-00) / 50 ml in 1 bottle, pump
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Titanium dioxide 10% Zinc oxide 15.2%

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 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 aBroad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 3 p.m. wear long-sleeved shirts, pants, hats and sunglasses reapply after swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: Ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients ALOE VERA LEAF JUICE*, ALUMINUM HYDROXIDE,BENZYL ALCOHOL, BISABOLOL*,CAPRYLIC/CAPRIC TRIGLYCERIDE,DEHYDROACETIC ACID, DICAPRYLYL CARBONATE,GLYCERYL BEHENATE, GLYCERYL DIBEHENATE,KARANJA TREE SEED EXTRACT, POLYGLYCERYL-2DIPOLYHYDROXYSTEARATE, POLYGLYCERYL-3DIISOSTEARATE, POLYHYDROXYSTEARIC ACID,PROPANEDIOL, SESAME OIL*, SODIUM CHLORIDE,STEARIC ACID, TOCOPHEROL, TRIBEHENIN, WATER.

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.
BIOSOLIS Face Sunscreen Broadspectrum SPF50 TITANIUM DIOXIDE, ZINC OXIDE ALOE VERA LEAF ALUMINUM HYDROXIDE BENZYL ALCOHOL LEVOMENOL MEDIUM-CHAIN TRIGLYCERIDES DEHYDROACETIC ACID DICAPRYLYL CARBONATE GLYCERYL MONOBEHENATE GLYCERYL DIBEHENATE PONGAMIA PINNATA SEED POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE POLYGLYCERYL-3 DIISOSTEARATE POLYHYDROXYSTEARIC ACID (2300 MW) PROPANEDIOL SESAME OIL SODIUM CHLORIDE STEARIC ACID TOCOPHEROL TRIBEHENIN WATER TITANIUM DIOXIDE TITANIUM DIOXIDE 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:61296-017-00 SPF50 Face outer level SPF50 Face tube

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

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 swallowed, get medical help or contact 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 the product in this container from excessive heat and direct sun.

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? 1-866-853-9427

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 and ask a doctor if rash occurs

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 swallowed, get medical help or contact 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