Celesty Colors Special Edition With Alix Avien
FDA Label NDC 81120-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Maba Kozmetik Limited Sirketi for the product Celesty Colors Special Edition With Alix Avien (NDC 81120-113). 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
Titanium Dioxide (Nano): 4%
Zinc Oxide: 0.999%
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 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.
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 and 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 - 30C
Inactive Ingredients
Aqua/Water/Eau, Cyclopentasiloxane, Isohexadecane, Ethylhexyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Pentylene Glycol, Disteardimonium Hectorite, Adipic Acid, Caprylic Acid, Benzyl PCA, Glycerin, Stearic Acid, Aluminum Hydroxide, Methicone, Sodium Levulinate, PPG-15 Stearyl Ether, Sodium Anisate, Vitis Vinifera (Grape) Seed Oil, Disodium EDTA, Tocopherol, Retinyl Palmitate, Talc, Helianthus Annuus (Sunflower) Seed Oil, Steareth-20, N-Hydroxysuccinimide, BHT, Palmitoyl Tripeptide-1, Chrysin, Palmitoyl Tetrapeptide-7, Chlorhexidine Digluconate, Potassium Sorbate. May Contain (+/-) Iron Oxides (CI 77491, CI 77492, CI 77499)
Packaging
Image (8112011301 1)
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