Maui Naturals All Natural Sunscreen
FDA Label NDC 58918-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hawaiian Classic Perfumes, Inc. for the product Maui Naturals All Natural Sunscreen (NDC 58918-002). 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 other, active ingredient, purpose, uses, otc - do not use, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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DRUG FACTS

Active Ingredient

Zinc Oxide (20%)

Purpose

Sunscreen

Uses

  • *helps prevent sunburn
  • *if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Otc - Do Not Use

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 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.

Directions

  • *apply liberally 15 minutes before sun exposure
  • *re-apply:
    • *after 80 minutes of swimming or sweating
    • *immediately after towel drying AND at least every 2 hours.
      • *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 of 15 or higher and other sun protection measures including:
        • *limit time in the sun, especially from 10 a.m. - 2 p.m.
        • *wear long-sleeve shirts, pants, hats, and sunglasses
        • *children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Capric Caprylic Triglycerides, Castor Oil, Hydrogenated Methyl Abietate, Jojoba Oil, Lemongrass Essential Oil, Magnesium Sulfate, Olive Oil, Polyaminopropyl Biguanide, Polyglycerol-10 Laurate, Rosemary Essential Oil, Sorbitan Stearate, Sunflower Oil, Tocopherols (Vitamin E), Purified Water.

Other Information

Contains no nano particles.

Protect this product from excessive heat and direct sun.

Principal Display Panel - 120 Ml Bottle Label

Maui Naturals

All Natural
Broad Spectrum
Sunscreen SPF 30

Eco/Reef Friendly

--no avo/oxybenzones
--no petrochemicals
--no nano particles
--80 minute water resistant

--with Maui Grown
Essential Oils

4 fl oz / 120 ml

* Please review the disclaimer below.