Drug Facts Active Ingredients
Titanium Dioxide (non-nano) 8.8%
Mackenzies Ocean Safe Sunscreen Cream
FDA Label NDC 80325-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naturally Uncommon, Llc for the product Mackenzies Ocean Safe Sunscreen (NDC 80325-030). 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, uses, warnings, otc - keep out of reach of children, directions, other info, inactive ingredients, 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.
Warnings
■ For external use only.
■ Do not use on damaged or broken skin.
■ Stop use and ask a doctor if rash occurs.
■ When using this product, keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
If product is 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 or immediately after towel drying and at least every 2 hours.
■ For children under 6 months of age; ask a doctor.
Other Info
Protect this product from excessive heat and sunlight.
Inactive Ingredients
Acrylates Copolymer, Alaria Esculenta (Wakame Seaweed) Extract*, Aloe Barbadensis (Aloe) Leaf Juice*, Alumina, Benzyl Alcohol, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cocoglycerides, Cocos Nucifera (Coconut Oil)*, Deionized Water, glycerin, Magnesium Aluminum Silicate, Methylcellulose, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europea (Olive) Leaf Extract*, Polyhydroxystearic Acid, Salicylic Acid, Sorbic Acid, Sorbitan Olivate, Sorbitan Palmitate, Stearic Acid, Tocopherol, Xanthan Gum.
*Certified Organic Ingredients
* Please review the disclaimer below.
