Celesty
FDA Label NDC 81120-108
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 (NDC 81120-108). 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, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Zinc Oxide (Nano)19,4%
Purpose
Sunscreen
Use
Helps prevent sunburn.
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, irritation and redness develop and persist for more than 72 hours.
Directions
• Apply minimum 30 minutes before sun exposure. • Repeat every 4 hours. • Reapply after swimming or sweating.
Other Information
Protect this product from excessive heat and direct sun. May stain some fabrics.
Inactive Ingredients
Water\Aqua\Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Carbomer, Glyceryl Stearate, Cetyl Alcohol, Sorbitan Stearate, PEG-100 Stearate, Laureth-4, Butylene Glycol, Dimethicone, Polyhydroxystearic Acid, Phenoxyethanol, Xanthan Gum, PEG-8, Polyethylene Glycol, Caprylyl Glycol, Sodium Lactate, Isostearic Acid, Teprenone, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Disodium EDTA, Triethanolamine, Ethylhexylglycerin, Tocopherol (Vitamin E), Sodium Acrylates Copolymer, Lecithin, Imperata Cylindrica Root Extract, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Plankton Extract, [+/- May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499)
Packaging
Image (8112010801 01)
Image (8112010801 02)
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