Gr Bb Spf 25 Cream
FDA Label NDC 82715-101
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 Bb Spf 25 (NDC 82715-101). 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 2.5% w/v
Oxybenzone 0.25% w/v
Titanium Dioxide 4.95% 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), Cyclopentasiloxane, Isododecane, Glycerin, PEG-9 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Phenyl Trimethicone, Talc, Acrylates/Dimethicone Copolymer, Silica Dimethyl Silylate, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Tocopheryl Acetate, PEG/PPG-18 /18 Dimethicone, White Bird of Paradise (Strelitzia nicolai) Seed Aril Extract, Propylene Carbonate, Pentylene Glycol, Potassium Sorbate, Disodium EDTA, Sorbic Acid, Triethoxycaprylylsilane, Lactic Acid, Serine, Sodium Lactate, Sorbitol, Urea, Magnesium Stearate, Fragrance, Silica, Isoceteth-10, Aluminum Hydroxide, Allantoin, Linalool, Mica*, Iron Oxides*, Bismuth Oxychloride*.
* contains one or more of these ingredients
Packaging
82715101-label (82715101 1)
* Please review the disclaimer below.
