Active Ingredients
Avobenzone 3%, Octisalate 5%, Octocrylene 10%
Cay Skin Isle Glow Body Spf 45 Lotion
FDA Label NDC 82657-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cay Skin, Inc. for the product Cay Skin Isle Glow Body Spf 45 (NDC 82657-003). 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, purpose, uses, warnings, do not use, when using this product, stop use and consult a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 Consult A Doctor
if skin rash occurs.
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children over 6 months of age:
- Apply liberally 15 minutes before sun exposure.
- Reapply: at least every 2 hours; immediately after towel drying.
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: ask a doctor.
- 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 this product from excessive heat and direct sun.
Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Sodium Potassium Aluminum Silicate, Diisopropyl Sebacate, Diisopropyl Adipate, Lauryl Lactate, Mica, Propanediol, Glyceryl Stearate, VP/Eicosene Copolylmer, Chondrus Crispus Extract, Limonium Gerberi Extract, Ferulic Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculents (Lentil) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Glycerin, Caprylic/Capric Triglyceride, Cetyl Phosphate, Glyceryl Stearate Citrate, Silica, Ethylene Brassylate, Caprylyl Glycol, 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Sodium Lactate, Sodium PCA, Sodium Benzoate, Potassium Sorbate, Disodium EDTA, Chlorphenesin, Synthetic Fluorphlogopite, Tin Oxide, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides)
Questions Or Comments?
cayskin.com (256) 396-8268
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