Protect Broad Spectrum Spf 30
FDA Label NDC 62742-4166

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs Inc for the product Protect Broad Spectrum Spf 30 (NDC 62742-4166). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient:

Zinc Oxide - 18.9%

Otc - Purpose

Purpose: Sunscreen

Indications & Usage

Uses:

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

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

Dosage & Administration

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply: after 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 of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10am - 2pm.
  • wear long sleeves shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.         

Other Safety Information

Protect this product from excessive heat and direct sun.

Inactive Ingredient

Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearic Acid, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isosrearic Acid, Lecithin, Cetyl Alcohol, Lanolin, Aloe Barbadensis Leaf Juice, Phomium Tenax Seed Oil, Stearyl Alcohol, Gardenia Jasminoides Meristem Cell Culture, Niacinamide, Prunus Amygdulus Dulcis (Sweet Almond) Oil, Honey, Tocopherol, Totarol, Ferulic Acid, Disodium EDTA, Xanthan Gum, Carageenan, Punica Granatum Extract, Dihydroacetic Acid, Corn Starch Modified, Benzyl Alcohol, Astaxanthin.

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Distributed by Distil Skincare LLC

Mailing address: Swapbox ATUP1-1T5DK,

880 Peru Ave #2, San Francisco 94112, USA

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