Maui Vera Mineral Sunscreen Spf 30 Unscented
FDA Label NDC 81409-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Maui Vera, Inc. for the product Maui Vera Mineral Sunscreen Spf 30 Unscented (NDC 81409-003). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Uncoated 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.

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 occurs.

Keep Out Of Reach Of Children.

If 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
  • Immediately after towel drying
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor

Other Information

Protect the product and this container from excessive heat and direct sun.

Inactive Ingredients

* Aloe Barbadensis Leaf Juice, *Morinda Citrifolia (Noni Fruit) Juice, * Arnica montana (Arnica) Extract, *Camellia sinensis (Green Tea), Extract, *Hamamelis virginiana (Witch Hazel) Extract, *MCT Oil, Sorbitane Olivate, Cetearyl Alcohol, Polysorbate 60, Steareth-20, Cetyl Alcohol, *Persea Americana (Avocado) Oil, Panthenol, Lauroyl Lysine, Vitamin E Acetate, Polyhydroxy Stearic Acid, Benzyl Alcohol, Dehydroacetic acid, Xanthan Gum, Sodium Phytate *Organic Ingredients

Questions Or Comments?

1-415-938-7808

Package Labelling:

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