Otc - Active Ingredient
Active Ingredients (% W/W): Avobenzone 3%, Homosalate 6%, Octyl Salicylate 5%
Cabanaclear Illuminating Lotion
FDA Label NDC 81104-594
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naked Sundays Pty Ltd for the product Cabanaclear Illuminating (NDC 81104-594). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Use:
• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun
Warnings
Warnings: For external use only.
• Do not use on damaged or broken skin.
Otc - When Using
• When using this product: Keep out of eyes. Rinse with water to remove.
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 product is swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions:
• Shake well before use.
• Apply liberally and evenly 20 minutes before sun exposure.
• Re-apply every 2 hours or immediately after swimming, sweating or 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 10.00AM - 2.00PM
• Wear long-sleeved shirts, pants, hats, and sunglasses
Other Safety Information
Other Information:
• Protect this product from excess heat and direct sun.
• Store below 30°C / 86°F
Questions:
Inactive Ingredient
Inactive Ingredients: Water, Butyloctyl Salicylate, Propylene Glycol, Acrylates Copolymer, Euphorbia Cerifera (Candelilla) Wax, Phenoxyethanol, Hydroxyacetophenone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6, Tocopheryl Acetate, Sodium Hyaluronate, Ethylhexylglycerin, Sodium Hydroxide, Disodium EDTA, Silica, t-Butyl Alcohol, Citric Acid, Sodium Benzoate, Tocopherol, Centella Asiatica Extract, Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxide (CI 77491, CI 77492, CI 77499), Tin Oxide (CI 77861)
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