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| Product NDC Code | 66888-050 | ||||
|---|---|---|---|---|---|
| Drug Name | Haute protection high protection tinted compact broad spectrum spf 50 |
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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 14.2 % ZINC OXIDE 4.9 %
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 for use Apply liberally/generously and evenly 15 minutes before sun exposure. Reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours. Children under 6 months: Consult a health care practitioner. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients DIMETHICONE, HYDROGENATED POLYISOBUTENE, PHENYL TRIMETHICONE, ISODECYL NEOPENTANOATE, SQUALANE, TALC, ETHYLHEXYL HYDROXYSTEARATE, SYNTHETIC WAX , POLYMETHYL METHACRYLATE, SILICA, WATER/EAU, POLYGLYCERLYL-3 DIISOSTEARATE, ALUMINA, STEARIC ACID, BEESWAX, CAPRYLIC/CAPRIC TRIGLYCERIDE, MICROCRYSTALLINE WAX, PHENOXYETHANOL, TOCOPHERYL GLUCOSIDE, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE, TITANIUM DIOXIDE (CI77891), IRON OXIDES (CI77492), (CI77491), (CI77499)
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 Tinted compact SPF 50 helps prevent sunburn. If used as directed with other sun protection measures (see Directions for use ), 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.HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 TITANIUM DIOXIDE, ZINC OXIDE DIMETHICONE HYDROGENATED POLYBUTENE (1300 MW) PHENYL TRIMETHICONE ISODECYL NEOPENTANOATE SQUALANE TALC ETHYLHEXYL HYDROXYSTEARATE SYNTHETIC WAX (1800 MW) POLY(METHYL METHACRYLATE; 450000 MW) SILICON DIOXIDE POLYGLYCERYL-3 DIISOSTEARATE ALUMINUM OXIDE WATER STEARIC ACID YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES MICROCRYSTALLINE WAX PHENOXYETHANOL TOCOPHERYL GLUCOSIDE .ALPHA.-TOCOPHEROL ACETATE TRIBEHENIN TRIETHOXYCAPRYLYLSILANE FERROUS OXIDE 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.PACKAGE LABEL - HIGH PROTECTION TINTED COMPACT BEIGE HAUTE PROTECTION HIGH PROTECTION COMPACT TEINTÉ – TINTED COMPACT SABLE - BEIGE RÉSISTANT À L’EAU WATER RESISTANT 40 minutes UVB UVA FPS SPF LARGE SPECTRE BROAD SPECTRUM 50 Peaux intolérantes – For intolerant skin NON COMÉDOGÉNE – N’OBSTRUE PAS LES PORES LABORATOIRES DERMATOLOGIQUES AVÈNE – PARIS 10g e NET WT. 0.3 OZ. NPN 80085668 Label
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions ? 1-866-41-AVENE (28363) (USA) 1-877-441-2011 (CAN)
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 consult a health care practitioner 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product 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.
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