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
Cabanamilk Mineral Barrier Fluid Lotion
FDA Label NDC 81104-593
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 Cabanamilk Mineral Barrier Fluid (NDC 81104-593). 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 indications & usage, otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient: Zinc Oxide 24%
Otc - Purpose
Sunscreen
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
Inactive Ingredient
Inactive Ingredients: Water, Coco-Caprylate/Caprate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Heptyl Undecylenate, Ethylhexyl Methoxycrylene, Isododecane, Lauryl PEG-8 Dimethicone, Polyglyceryl-3 Diisostearate, Propanediol, Aluminum Starch Octenylsuccinate, Stearalkonium Hectorite, Magnesium Sulfate, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Dimethicone, Hydroxyacetophenone, Simmondsia Chinensis (Jojoba) Seed Oil, Phenoxyethanol, Propylene Carbonate, Glycerin, Pongamia Pinnata Seed Extract, Ethylhexylglycerin, Oryza Sativa (Rice) Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Althaea Officinalis (Marshmallow) Root Extract, Jojoba Esters, Sodium Hyaluronate, Tocopherol, Leuconostoc/Radish Root Ferment Filtrate, Nelumbo Nucifera Flower Extract, Hibiscus Sabdariffa Flower Extract, Potassium Sorbate, Sodium Benzoate, Dunaliella Salina Extract, Iron Oxides (CI 77492, CI 77491, CI 77499).
Dosage & Administration
Directions:
• Shake well before use.
• Apply liberally and evenly 15 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:
* Please review the disclaimer below.
