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| Product NDC Code | 74740-450 | ||||
|---|---|---|---|---|---|
| Drug Name | Tibena every day real sun block |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | KONAD CO LTD | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Titanium Dioxide 3.12 % Zinc Oxide 19.2 %
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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses ■ Children under 6 months of age: Ask a doctor ■ 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.Inactive ingredients Water, Butylene Glycol, Butyloctyl Salicylate, Cetyl Ethylhexanoate, Ethylhexyl Methoxycrylene, Niacinamide, Stearic Acid, Polyglyceryl-3 Methylglucose Distearate, 1,2-Hexanediol, Cetearyl Alcohol, Glyceryl Stearate, Polyglyceryl-10 Oleate, Gluconolactone, Polyglyceryl-4 Oleate, Triethoxycaprylylsilane, Aluminum Hydroxide, Caprylyl Glycol, Sodium Polyacryloyldimethyl Taurate, Sphingomonas Ferment Extract, Polyglyceryl-3 Polyricinoleate, Xanthan Gum, Tocopherol, Ethylhexylglycerin, Adenosine, Centella asiatica Extract, Lavandula Angustifolia Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita Flower Extract, Rosmarinus Officinalis Leaf Extract, Asiaticoside, Asiatic acid, Madecassic acid, Madecassoside
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.TIBENA EVERY DAY REAL SUN BLOCK Titanium Dioxide, Zinc Oxide CAPRYLYL GLYCOL ADENOSINE MADECASSIC ACID BUTYLOCTYL SALICYLATE BUTYLENE GLYCOL ZINC OXIDE ZINC OXIDE TRIETHOXYCAPRYLYLSILANE SODIUM POLYACRYLOYLDIMETHYL TAURATE GLYCERYL MONOSTEARATE TOCOPHEROL ROSEMARY ALUMINUM HYDROXIDE ASIATIC ACID CENTELLA ASIATICA TRITERPENOIDS CETYL ETHYLHEXANOATE POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE WATER NIACINAMIDE STEARIC ACID CETOSTEARYL ALCOHOL POLYGLYCERYL-10 OLEATE GLUCONOLACTONE POLYGLYCERYL-4 OLEATE XANTHAN GUM MONARDA DIDYMA LEAF ASIATICOSIDE ETHYLHEXYL METHOXYCRYLENE 1,2-HEXANEDIOL MADECASSOSIDE ETHYLHEXYLGLYCERIN TITANIUM DIOXIDE TITANIUM DIOXIDE
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.TIBENA EVERY DAY REAL SUN BLOCK
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 skin 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 form excessive heat or direct sun. ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
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
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