Otc - Active Ingredient
ACTIVE INGREDIENTS:
HOMOSALATE (6%)
MERADIMATE (4%)
OCTINOXATE (%)
OXYBENZONE (4.5%)
Aloe Up Medicated Lip Ice Sunscreen
FDA Label NDC 61477-215
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 Up Medicated Lip Ice Sunscreen (NDC 61477-215). 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, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE:
SUNSCREEN
Indications & Usage
INDICATIONS:
HELPS PREVENT SUNBURN.
Dosage & Administration
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.
Warnings
WARNINGS:
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 SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Inactive Ingredient
Other Ingredients:
ALOE VERA OIL, CAMPHOR, CETYL ALCOHOL, MENTHOL, MINERAL OIL, OZOKERITE WAX, PETROLATUM, TITANIUM DIOXIDE, TOCOPHEROL
* Please review the disclaimer below.
