Broad Spectrum Spf 30 For Face And Body Cream
FDA Label NDC 62742-4116

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 Broad Spectrum Spf 30 For Face And Body (NDC 62742-4116). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients: Zinc Oxide - 18.6%

Otc - Purpose

Purpose: Sunscreen

Indications & Usage

Uses:

  • Provided high protection against sunburn.
  • Broad Spectrum (UVA and UVB) protection.
  • If used with directed with other sun protection measures,decreases the risk of skin cancer and early skin aging caused by sun. 

Warnings

Warnings: For external use only.

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 or irritation occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions:

  • Apply generously 15 minutes before su exposure.
  • Reapply at least every 2 hours. After swimming or sweating. Immediately after towel drying.
  • Children under 6 months of age: ask a doctor.

Other Safety Information

Other Information High sun protection product.

Otc - Questions

Call toll free 1-800-798-7970

Inactive Ingredient

Water (Aqua), Cyclopentasiloxane, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Polyacrylamide, C13-14 Isoparaffin, Lecithine, Imperata Cylindrica Root Extract, Xanthan Gum, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Carbomer, PEG-8, Disodium EDTA.

Package Label.Principal Display Panel

Made in USA

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

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