FDA Label for Gr Bb Spf 25

View Indications, Usage & Precautions

Gr Bb Spf 25 Product Label

The following document was submitted to the FDA by the labeler of this product Erkul Kozmetik Sanayi Ve Ticaret Anonim Sirketi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




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




* Please review the disclaimer below.