Aloevella
FDA Label NDC 55115-2041

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ojas Enterprises Llc for the product Aloevella (NDC 55115-2041). 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, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients

Titanium dioxide 5%

Zinc Oxide 15%

purpose

Sunscreen

Uses 

• Helps prevent sunburn

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increase

your risk of skin cancer and early skin aging.This product has been

shown only to prevent sunburn,not skin cancer or early skin aging

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

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:

   • after 40 minutes of swimming or sweating

   • immediately after towel drying

   • at least every 2 hours

• children under 6 months: Ask a doctor

Inactive ingredients

water, Almond oil, Sesame oil, Soy bean oil, Jojoba oil, Cetearyl olivate, sorbitan olivate, Stearic acid,

Aloevera, Vitamin E oil, Sodium Benzoate, Cetyl Alcohol, Whetgerm oil, D Panthanol, Olive leaf extract,

fragrance, Carrot extract, Green tea extract, Licorice extract, Neem extract, Cucumber extract, Glyceryl

stearate, Xanthan gum

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-866-855-9006

Package Label.Principal Display Panel

Product Label (Label)

Product Label (Label)

   

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