Solar Protection Formula Spf 58
FDA Label NDC 58892-911

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fallien Cosmeceuticals, Ltd. for the product Solar Protection Formula Spf 58 (NDC 58892-911). 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:, warnings:, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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DRUG FACTS

Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose

Sunscreen

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 - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

Keep out of the 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 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10:00 a.m.-2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information:

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Inactive Ingredients:

Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

Package Label.Principal Display Panel

Principal Display Panel – Carton Label

NDC 58892-911-88

SOLAR
PROTECTION
FORMULA®

Gentle Mineral
Sunscreen

SPF 58
Broad Spectrum
Water Resistent
(40 minutes)

Net Wt. 2.5 Oz./ 70g

Principal Display Panel – Carton Label (Sol01 0001 01)

Principal Display Panel – Carton Label (Sol01 0001 01)

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