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| Product NDC Code | 80325-040 | ||||
|---|---|---|---|---|---|
| Drug Name | Mackenzies spf 40 ocean safe sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Naturally Uncommon LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc Oxide 20%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Helps prevent sunscreen.
Purpose
Information about the drug product’s indications for use.Sunscreen.
Spl product data elements
Usually a list of ingredients in a drug product.Mackenzies SPF 40 Ocean Safe Sunscreen Zinc Oxide CETOSTEARYL ALCOHOL CETYL PALMITATE ALMOND OIL SQUALENE SUNFLOWER OIL HOLY BASIL LEAF POLYHYDROXYSTEARIC ACID (2300 MW) SILICON DIOXIDE TOCOPHEROL OLEA EUROPAEA LEAF SORBITAN OLIVATE ZINC OXIDE ZINC OXIDE ALARIA ESCULENTA YELLOW WAX JOJOBA OIL, RANDOMIZED GREEN TEA LEAF
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Label Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If product is swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API