Otc - Active Ingredient
Zinc Oxide 20%
Mackenzies Spf 40 Ocean Safe Sunscreen Cream
FDA Label NDC 80325-040
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 Spf 40 Ocean Safe Sunscreen (NDC 80325-040). 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 - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, 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
Helps prevent sunscreen.
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 ask a doctor if rash or irritation develops and lasts.
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- 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.
Inactive Ingredient
Alaria Esculenta (Wakame Seaweed) Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Cera Alba (Beeswax), Cetearyl Alcohol, Cetyl Palmitate, Helianthus Annus (Sunflower) Seed Oil, Jojoba Esters, Mixed Tocopherols (Vitamin E), Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Olea Europea (Olive) Leaf Extract*, Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalene (Plant Based)
*Certified Organic Ingredients
Package Label.Principal Display Panel
* Please review the disclaimer below.
