Aloe Kote Cream
FDA Label NDC 61477-225

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aloe Care International, Llc for the product Aloe Kote (NDC 61477-225). 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 active ingredients:, purpose:, uses, directions:, otc - keep out of reach of children, warnings:, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

OCTINOXATE (7.4%)

OXYBENZONE (5.9%)

HOMOSALATE (14.5%)

Purpose:

SUNSCREEN

Uses

HELPS PREVENT SUNBURN.

Directions:

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

Inactive Ingredients

Aloe Oil Extract, Ganex V-220, Ozokerite Wax #871, Protopet Alba USP

Other Information

• Protect this product from excessive heat and direct sun

Questions Or Comments?

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