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| Product NDC Code | 67015-2036 | ||||
|---|---|---|---|---|---|
| Drug Name | Haute protection high protection tinted compact broad spectrum spf 50 beige |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Pierre Fabre USA Inc. | ||||
| 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 13.7 % 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 evenly15 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 skin protection measures including: limit time in the sun, especially from 10 a.m. - 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, POLYETHYLENE, POLYMETHYL METHACRYLATE, SILICA, WATER/EAU, POLYGLYCERLYL-3 DIISOSTEARATE, ALUMINA, STEARIC ACID, BEESWAX, BHT, CAPRYLIC/CAPRIC TRIGLYCERIDE, MICROCRYSTALLINE WAX, PHENOXYETHANOL, TOCOPHEROL, 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 if 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 Beige TITANIUM DIOXIDE, ZINC OXIDE WATER FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE FERRIC OXYHYDROXIDE HYDROGENATED POLYBUTENE (1300 MW) FERRIC OXIDE RED MEDIUM-CHAIN TRIGLYCERIDES BUTYLATED HYDROXYTOLUENE ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE TRIETHOXYCAPRYLYLSILANE TRIBEHENIN MICROCRYSTALLINE WAX ALUMINUM OXIDE POLY(METHYL METHACRYLATE; 450000 MW) SQUALANE TOCOPHEROL PHENOXYETHANOL YELLOW WAX SILICON DIOXIDE HIGH DENSITY POLYETHYLENE TALC ISODECYL NEOPENTANOATE PHENYL TRIMETHICONE DIMETHICONE POLYGLYCERYL-3 DIISOSTEARATE ETHYLHEXYL HYDROXYSTEARATE STEARIC ACID
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.HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 BEIGE 10g (67015-2036-0) HAUTE PROTECTION HIGH PROTECTION Fragrance-free SPF 50 UVB UVA Broad spectrum Water-resistant 40 minutes Beige Tinted compact For intolerant skin PARIS 10g e/NET WT. 0.3 OZ.- NPN80085668 AV Compact Beige
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.
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 Do not use on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and consult a health care practitioner if rash occurs.
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