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| Product NDC Code | 82715-107 | ||||||||||||||||||||||
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| Drug Name | Gr longstay matte face powder spf 15 |
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| Type | Brand | ||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||
| Dosage Form | POWDER | ||||||||||||||||||||||
| Application Number | part352 | ||||||||||||||||||||||
| Labeler Name | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | ||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Octinoxate 1.995% w/v
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 generously 15 minutes before the sun exposure • apply to cleansed skin • can be applied two coats to increase coverage • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 sun Broad Spectrum SPF value of 15 or higher and other 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Talc, Dimethicone, Silica, Polymethyl Methacrylate, Zinc Stearate, Diisostearyl Malate, Hexyl Laurate, Triethoxycaprylylsilane, Aluminum Hydroxide, Titanium Dioxide, Phenoxyethanol, Allantoin, Dichlorobenzyl Alcohol, Magnesium Stearate, *Mica, *Iron Oxodes. *contains one or more of these ingredients.
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 Sun Screen
Spl product data elements
Usually a list of ingredients in a drug product.GR LONGSTAY Matte Face Powder SPF 15 Octinoxate OCTINOXATE OCTINOXATE TALC DIMETHICONE SILICON DIOXIDE POLY(METHYL METHACRYLATE; 450000 MW) ZINC STEARATE DIISOSTEARYL MALATE HEXYL LAURATE TRIETHOXYCAPRYLYLSILANE ALUMINUM HYDROXIDE TITANIUM DIOXIDE PHENOXYETHANOL ALLANTOIN DICHLOROBENZYL ALCOHOL MAGNESIUM STEARATE MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC 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.Packaging ERKUL-107
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.Drug Facts
SPF 15 LONG LASTING UP TO 16HR • Good Coverage • Silky, Smooth and Soft Finish • Shine Control DERMATOLOGICALLY TESTED Manufactured By: ERKUL COSMETICS San. Tic. A.Ş., Petrol Ofisi Cad. No:1 Avcılar, ISTANBUL, TURKIYE, 34310 Phone: +90 212 456 53 00 www.goldenrose.com.tr [email protected] MADE IN TURKIYE Distributed By: CELESTY LLC 3970 NW 167 TH ST. MIAMI GARDENS, FL 33054 – USA [email protected] EU R.P: Platin Beauty Consulting UG (haftungsbeschränkt) Bardowicker Str. 6, 21335 Lüneburg/GERMANY
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 a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information • protect the product in this container from excessive heat and direct sun. • store at room temperatures: 15°C- 30°C.
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 a doctor if • rash occurs Keep out of 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