Gr Cc Broad Spectrum Spf 30 Cream
FDA Label NDC 82715-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Erkul Kozmetik Sanayi Ve Ticaret Anonim Sirketi for the product Gr Cc Broad Spectrum Spf 30 (NDC 82715-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octinoxate 6% w/v
Oxybenzone 2% w/v
Purpose
Sunscreen
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
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
Other Information
• protect the product in this container from excessive heat and direct sun. • store at room temperatures: 15°C- 30°C.
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.
Packaging
Erkul-102 (8271510201 1)
Erkul-102 (8271510201 2)
* Please review the disclaimer below.
