Sun Protection Mineral Powder
FDA Label NDC 54108-1487

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Derma E for the product Sun Protection Mineral (NDC 54108-1487). 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 ingredients, purpose, uses, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only

Distributed by DERMA E®
North Amityville, NY 11701, USA

Active Ingredients

Zinc Oxide 24.5%

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 - 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply throughout the day
  • Children under 6 months of age:
    Ask a doctor
  • 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 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
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating

Inactive Ingredients

Aluminum Starch Octenylsuccinate, Mica, Silica, Lauroyl Lysine, Kaolin, Calcium Carbonate, Caprylic/Capric Triglyceride, CI 77492, Triethoxycaprylylsilane, CI 77491, CI 77499, Bisabolol, Ceramide NP, Ascorbic Acid, Tocopheryl Acetate, Capryloyl Glycine, Undecylenoyl Glycine, Sodium Benzoate, Potassium Sorbate.

Other Information

  • protect this product from excessive heat and direct sun.

Principal Display Panel - 5 G Applicator Box

ESSENTIALS

NEW
LOOK!
same
formula

DERMA∙E

Sun Protection
Mineral Powder
SPF 30

PROTECTS + MATTIFIES
24.5% zinc oxide
ceramides

broad spectrum UVA/UVB

DERMATOLOGIST
RECOMMENDED

0.16 OZ / 5 g

Principal Display Panel (5 g Applicator Box)

Principal Display Panel (5 g Applicator Box)

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