Aloe Up Natural Lip Ice Sunscreen
FDA Label NDC 61477-214

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 Natural Lip Ice Sunscreen (NDC 61477-214). 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 - Active Ingredient

ACTIVE INGREDIENTS:

OCTINOXATE (%)

OXYBENZONE (4.5%)

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 BARBADENSIS LEAF JUICE, BEESWAX, BHT, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOS NUCIFERA (COCONUT) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED VEGETABLE OIL, LANOLIN, MANGIFERA INDICA (MANGO) SEED BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, RICINUS COMMUNIS (CASTOR) SEED OIL, TOCOPHEROL, TOCOPHERYL ACETATE (VITAMIN E)

Package Label.Principal Display Panel

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