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| Product NDC Code | 82715-102 | ||||||||||
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| Drug Name | Gr cc broad spectrum spf 30 |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | CREAM | ||||||||||
| Application Number | part352 | ||||||||||
| Labeler Name | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | ||||||||||
| 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 Octinoxate 6% w/v Oxybenzone 2% 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), Dimethicone, Polymethylsilsesquioxane, Butylene Glycol, Squalane, Peg-40 Stearate, Behenyl Alcohol, Glyceryl Stearate, Talc, Phenyl Trimethicone, Polyglyceryl-10 Pentastearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Tocopheryl Acetate, Titanium Dioxide, Sodium Stearoyl Lactylate, Glycerin, Pentylene Glycol, Strelitzia Nicolai Seed Aril Extract, Sodium Dehydroacetate, Acrylates Copolymer, Polysorbate 60, Isopropyl Titanium Triisostearate, Citric Acid, Fructose, Sodium Hydroxide, Urea, Ethylhexylglycerin, Tromethamine, Magnesium Stearate, Sorbitan Isostearate, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium Pca, Trehalose, Aluminum Hydroxide, Sodium Laureth-12 Sulfate, Caprylyl Glycol, Glucose, Sodium Hyaluronate, C11-15 Pareth-7, Potassium Sorbate. *Mica, *Iron oxides, *Yellow 5, * Blue 1, *Chromium Oxide Greens, Ultramarine. *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 CC Broad Spectrum SPF 30 Octinoxate, Oxybenzone OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE WATER DIMETHICONE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) BUTYLENE GLYCOL SQUALANE PEG-40 STEARATE DOCOSANOL GLYCERYL MONOSTEARATE TALC PHENYL TRIMETHICONE POLYGLYCERYL-10 PENTASTEARATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE TITANIUM DIOXIDE SODIUM STEAROYL LACTYLATE GLYCERIN PENTYLENE GLYCOL STRELITZIA NICOLAI WHOLE SODIUM DEHYDROACETATE LUVISET 360 POLYSORBATE 60 ISOPROPYL TITANIUM TRIISOSTEARATE CITRIC ACID MONOHYDRATE FRUCTOSE SODIUM HYDROXIDE UREA ETHYLHEXYLGLYCERIN TROMETHAMINE MAGNESIUM STEARATE SORBITAN ISOSTEARATE ALLANTOIN MALTOSE, UNSPECIFIED FORM SODIUM CHLORIDE SODIUM LACTATE SODIUM PYRROLIDONE CARBOXYLATE TREHALOSE ALUMINUM HYDROXIDE SODIUM LAURETH-12 SULFATE CAPRYLYL GLYCOL ANHYDROUS DEXTROSE HYALURONATE SODIUM C11-15 PARETH-7 POTASSIUM SORBATE MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE FD&C YELLOW NO. 5 FD&C BLUE NO. 1 CHROMIC OXIDE ULTRAMARINE BLUE
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-102 ERKUL-102
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
GOLDEN ROSE COLOR CORRECTING PRIMER Correct • Brighten • Protect Green correcting shade neutralises redness tone for a flawless make-up. Orange correcting shade neutralises the look of dark circles & brown spots on medium to deep skin tones for a flawless make-up. Violet correcting shade neutralises dull yellow undertones on light to medium skin tones for a flawless make-up. Yellow correcting shade neutralises purple/blue tones corrects mild redness tone for a flawless make-up. • Smooths, evens and brightens skin tone, hide dullness and dark spots. • Contains skin friendly pure moisturiser complex. • With SPF 30 to protect your skin against the harmful sunrays. Apply to cleaned skin. Can be used alone or under foundation. DERMATOLOGICALLY TESTED Manufactured By: ERKUL COSMETICS San. Tic. A.Ş., Petrol Ofisi Cad. No:1 Avcılar, Istanbul, Turkey, 34310 Phone: +90 212 456 53 00 www.goldenrose.com.tr [email protected] MADE IN TURKEY 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