Gentle Hydrating Sunscreen Broad Spectrum Spf 30
FDA Label NDC 62742-4189

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 Gentle Hydrating Sunscreen Broad Spectrum Spf 30 (NDC 62742-4189). 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 and precautions, 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 Ingredients:

Zinc Oxide 18.9%

Otc - Purpose

Purpose: Sunscreen

Indications & Usage

Uses:

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

Warnings And Precautions

Warning: 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 Center right away.

Dosage & Administration

Directions:

  • Apply generously 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor. 
  • Reapply at least every 2 hours.
  • Sun protection measures: Spending time in the sun increase 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 10am - 2pm.
  • Wear long sleeved shirts, pants, hats and sunglasses.

Other Safety Information

Other Information: Protect the product from excessive heat and direct sun.

Inactive Ingredient

Inactive Ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Cetearyl Glucoside, Caprylyl/Capryl Glucoside, Dipotassium Glycyrrhizate, Camellia Sinensis Leaf Extract, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Sodium Phytate, Lecithin, Tocopherol, Xanthan Gum, Sclerotium Gum, Phenoxyethanol, Ethylhexylglycerin,  Sodium Benzoate, Potassium Sorbate.

Otc - Questions

Questions or Comments?

Call toll free 707-230-2284; www.eczemahoneyco.com

Package Label.Principal Display Panel

Manufactured by Allure Labs

For Eczema Honey CO IN

Partnership:

Hayward, CA, 94545

* Please review the disclaimer below.