Active Ingredients
Zinc Oxide 7%
Titanium Dioxide 3.5%
Avobenzone 3.5%
Octinoxate 7%
Calliel Tinted Glow Spf 50 Medium Cream
FDA Label NDC 87411-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Calliel Pharma Kozmetik Sanayi Ve Ticaret Anonim Sirketi for the product Calliel Tinted Glow Spf 50 Medium (NDC 87411-0002). 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 active ingredients, uses, otc - do not use, otc - stop use, otc - keep out of reach of children, directions, warnings, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Stop Use
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 liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months: Ask a doctor
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging caused by the sun. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
Warnings
For external use only
Purpose
Sunscreen
Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Butyrospermum Parkii Butter, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Propylene Glycol, Isopropyl Myristate, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, Xylitylglucoside, Phenoxyethanol, PEG-10 Dimethicone, Iron Oxides, Disteardimonium Hectorite, Anhydroxylitol, Xylitol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Triethoxycaprylylsilane
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