Mineral Spf 30 Brush-on Sun Defense Powder
FDA Label NDC 55789-1501

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mineral Fusion for the product Mineral Spf 30 Brush-on Sun Defense (NDC 55789-1501). 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, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. By Mineral Fusion, Petaluma, CA 94954 USA

Active Ingredient

Zinc Oxide 24%

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.

Otc - Do Not Use

  • Do not use on damaged or broken skin.

Otc - When Using

  • When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor.
  • Use: Remove cap and slide down brush sleeve. Tap brush gently against wrist until you see powder flow through the bristles. Brush generously onto skin.
  • 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.

Other Information

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

Inactive Ingredients

Mica, Silica, Lauroyl Lysine, Boron Nitride, Plankton Extract, Caprylic/Capric Triglyceride, Himanthalia Elongata Extract, Tocopherol, Glutamic Acid, Lysine HCl, Zinc PCA, Serine, Capryloyl Glycine, Sodium PCA, Undecylenoyl Glycine, Sodium Polyaspartate, Butylene Glycol, Arginine, Sodium Citrate, Aqua/Water/Eau, Betaine, Iron Oxides (CI 77491, CI 77492, CI 77499).

Questions?

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Principal Display Panel - 4.0 G Tube Carton

Mineral SPF 30
Brush-On Sun Defense

Broad Spectrum SPF 30
Sunscreen Powder

MINERAL
FUSION®

Making Beauty Healthy®

Net Wt 0.14 oz / 4.0 g

Principal Display Panel (4.0 g Tube Carton)

Principal Display Panel (4.0 g Tube Carton)

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