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| Product NDC Code | 66888-346 | ||||
|---|---|---|---|---|---|
| Drug Name | Titanium dioxide |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Tecnocosmesi S.p.A | ||||
| 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 9.90%
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 Shake before use. Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua/Eau, dimethicone, octyldodecyl stearoyl stearate, glycerin, phenyl trimethicone, magnesium sulfate, octyldodecanol, hydrogenated castor oil, cetyl PEG/PPG-10/1 dimethicone, polyglyceryl-3 diisostearate, cetyl dimethicone, disteardimonium hectorite, tremella fuciformis (mushroom) extract, aloe barbadensis leaf juice powder, persea gratissima (avocado) oil, opuntia ficus-indica stem extract, squalane, sodium hyaluronate, glycyrrhiza glabra (licorice) root extract, caprylyl glycol, stearic acid, alumina, potassium sorbate, sodium dehydroacetate, trimethylsiloxysilicate, sodium benzoate, xanthan gum, tocopherol, ethylhexyl palmitate, methicone, butylene glycol, 1,2-hexanediol, trihydroxystearin, sodium hyaluronate, disodium phosphate, ascorbyl palmitate, glucomannan, titanium dioxide (CI 77891), iron oxides (CI 77491, CI 77492, CI 77499), TE111FL000831.
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 Suncreen
Spl product data elements
Usually a list of ingredients in a drug product.Titanium Dioxide Sunscreen POLYGLYCERYL-3 DIISOSTEARATE WATER AVOCADO OIL OPUNTIA FICUS-INDICA STEM GLYCYRRHIZA GLABRA POTASSIUM SORBATE ETHYLHEXYL PALMITATE KONJAC MANNAN TOCOPHEROL DIMETHICONE OCTYLDODECANOL DISTEARDIMONIUM HECTORITE TREMELLA FUCIFORMIS WHOLE HYDROGENATED CASTOR OIL TRIHYDROXYSTEARIN ASCORBYL PALMITATE ALUMINUM OXIDE DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (35/65 W/W; 10000000 PA.S) 1,2-HEXANEDIOL PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER MAGNESIUM SULFATE, UNSPECIFIED CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) FERRIC OXIDE RED SODIUM BENZOATE BUTYLENE GLYCOL SODIUM DEHYDROACETATE SQUALANE CAPRYLYL GLYCOL STEARIC ACID XANTHAN GUM FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE OCTYLDODECYL STEAROYL STEARATE GLYCERIN PHENYL TRIMETHICONE ALOE VERA LEAF METHICONE (20 CST) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 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.Principal Display Panel tarte high performance naturals shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen tube box
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 the reach of children. If 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 the product in this container from excessive heat and direct sunlight. You may report a serious adverse reaction to tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222.
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 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. Stop use and ask doctor if rash occurs. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If 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