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Product NDC Code | 70116-013 | ||||
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Drug Name | Eezysun spf50 babies and kids |
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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 | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | BIO EARTH MANUFACTURING (PTY) LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Titanium Dioxide 3.5%, Zinc Oxide 9.5%
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.Direction Apply liberally 15 minutes before sun exposure Reapply after 40 minutes if swimming or sweating immediately after towel drying at least every two hours Sun protection measures use a broad-spectrum sunscreen with an SPF value of 50 or higher limit time in the sun, especially from 10am - 2pm wear long-sleeve shirts, pants, hats, sunglasses 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, Ascorbic Acid, Barium Sulphate, Bulbinella, Carnauba, Castor Seed Oil, Cetearyl Alcohol, Chamomile Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, 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 prevents 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 Topical SPF50 Sun Cream for the prevention of sun burn
Spl product data elements
Usually a list of ingredients in a drug product.Eezysun SPF50 Babies and Kids Titanium Dioxide, Zinc Oxide ALOE VERA LEAF POLYSACCHARIDES ASCORBIC ACID BARIUM SULFATE BULBINE FRUTESCENS WHOLE CHAMOMILE FLOWER OIL CARNAUBA WAX CASTOR OIL CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE HYDROGENATED CASTOR OIL HYDROXYETHYL CELLULOSE, UNSPECIFIED PHENOXYETHANOL ROSA MOSCHATA OIL SOYBEAN OIL .ALPHA.-TOCOPHEROL ACETATE WATER XANTHAN GUM 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.Product label image description
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.Other information Store at or below 77℉. Do not use if seal is broken Protect the product in this container 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 doctor if rash occurs Keep out of reach of children
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