Alix Avien
FDA Label NDC 82668-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alix Avien Kozmetik Sanayi Ticaret Anonim Sirketi for the product Alix Avien (NDC 82668-100). 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:, use, 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: 4.5%
Purpose:
Sunscreen
Use
• Helps prevent sunburn
Warnings
For external use only
Skin Cancer / Skin Aging Alert • Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• Do not use on damaged or broken skin
When using this products • 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.
Directions
• Apply generously 15 minutes before the sun exposure
• Children under 6 months of age: ask a doctor. • 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 Broad Spectrum SPF value of 15 or higher ad other sun protection measures including: • Limit time in the sun, especially from 10 a.m.- 2 p.m. • Wear long-sleeved shirts, pants, hats and sunglasses.
Other Information
• Protect the product in this container from excessive heat and direct sunlight.
• Store at room temperature: 15C - 25C
Inactive Ingredients
Aqua/Water/Eau, Cyclopentasiloxane, Glycerin, Dimethicone, Isopropyl Myristate, Sorbitan Olivate, Silica Dimethyl Silylate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Titanium Dioxide(CI 77891), Sodium Chloride, Mica (CI 77019), Triethyl Citrate, Phenoxyethanol, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire De Candelilla, Brassica Campestris Sterols, Cetearyl Alcohol, Parfum/Fragrance, Iron Oxide (CI 77492), Hydrogenated Vegetable Oil, Beeswax/Cera Alba, Stearic Acid, Iron Oxide (CI 77491), Acrylates / Ammonium Methacrylate Copolymer, Ethylhexylglycerin, Tasmannia Lanceolata Fruit/Leaf Extract, Stearyl Stearate, Triethoxycaprylylsilane, Linalool, Citronellol, Alpha-Isomethyl Ionone, Limonene, Benzyl Alcohol.
Packaging
Image (82668 100 01 2)
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