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| Product NDC Code | 82715-106 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Gr total cover 2 in 1 foundation and concealer spf 15 |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Dosage Form | LOTION | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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% 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 Water (Aqua), Cyclopentasiloxane, Dimethicone, Peg-10 Dimethicone, Phenyl Trimethicone, Peg-9 Polydimethylsiloxyethyl Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Caprylyl Methicone, Trımethylsiloxysilicate, Propylene Glycol, Silica Dimethyl Silylate, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Polypropylsılsesquioxane, Sodıum Chloride, Zinc Pca, Phenoxyethanol, Silica, Dimethicone Crosspolymer, Peg-12 Dimethicone/Ppg-20 Crosspolymer, Tocopheryl Acetate, Peg/Ppg-18/18 Dimethicone, Talc, Isododecane, Xanthan Gum, Triethoxycaprylylsilane, Titanium Dioxide, Ethylhexylglycerın, Disodium Edta, Isoceteth-10, Fragrance, Magnesium Stearate, Aluminum Hydroxide, Linalool. * Iron Oxides. *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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.GR TOTAL COVER 2 in 1 Foundation and Concealer SPF 15 Octinoxate OCTINOXATE OCTINOXATE WATER CYCLOMETHICONE 5 DIMETHICONE PEG-10 DIMETHICONE (600 CST) PHENYL TRIMETHICONE PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE CAPRYLYL TRISILOXANE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) PROPYLENE GLYCOL SILICA DIMETHYL SILYLATE DISTEARDIMONIUM HECTORITE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED SODIUM CHLORIDE ZINC PIDOLATE PHENOXYETHANOL SILICON DIOXIDE DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER .ALPHA.-TOCOPHEROL ACETATE PEG/PPG-18/18 DIMETHICONE TALC ISODODECANE XANTHAN GUM TRIETHOXYCAPRYLYLSILANE TITANIUM DIOXIDE ETHYLHEXYLGLYCERIN EDETATE DISODIUM ANHYDROUS ISOCETETH-10 MAGNESIUM STEARATE ALUMINUM HYDROXIDE LINALOOL, (+/-)- 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-106
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 Vitamin E 01 PORCELAIN •Full Coverage & Longwear •Semi-Matte & Smooth Finish •Lightweight/Non-Oily Formula DERMATOLOGICALLY TESTED ERKUL KOZMETIK San. Tic. A.Ş., P.Ofisi Cd. No:1 Avcılar, IST./TURKEY MADE IN TURKEY 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