Aloe Up Pro 15 Spray
FDA Label NDC 61477-207

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 Pro 15 (NDC 61477-207). 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:

AVOBENZONE (3%)

OCTISALATE (5%)

OCTOCRYLENE (2.75%)

Otc - Purpose

PURPOSE:

SUNSCREEN

Indications & Usage

INDICATIONS:

HELPS PREVENT SUNSCREEN.

Dosage & Administration

DIRECTIONS:

SPRAY LIBERALLY AND SPREAD EVENLY BY HAND 15 MINUTES BEFORE SUN EXPOSURE.

HOLD 4 TO 6 INCHES FROM THE SKIN TO APPLY.

DO NOT SPRAY DIRECTLY INTO FACE. SPRAY ON HANDS THEN APPLY TO FACE.

DO NOT APPLY IN WINDY CONDITIONS.

USE IN A WELL-VENTILATED AREA.

REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL DRYING, AT LEAST EVERY 2 HOURS.

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. KEEP AWAY FROM FACE TO AVOID BREATHING IT. CONTENTS UNDER PRESSURE- DO NOT PUNCTURE OR INCINERATE. DO NOT STORE AT TEMPERATURES ABOUT 120 F. 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. FLAMMABLE: DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING.

Inactive Ingredient

Other Ingredients:

ALOE BARBADENSIS EXTRACT, COCOS NUCIFERA (COCONUT) OIL, DIETHYLHEXYL 2,6-NAPHTHALATE, MINERAL OIL (PARAFFINUM LIQUIDUM), POLYESTER-8, SD ALCOHOL 40-B (ALCOHOL DENAT.), VA/BUTYL MALEATE/ISOBORNYL ACRYLATE COPOLYMER

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