ALOE UP PRO 50 CONTINUOUS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

ALOE UP PRO 50 by

Drug Labeling and Warnings

ALOE UP PRO 50 by is a Otc medication manufactured, distributed, or labeled by Aloe Care International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

AVOBENZONE (3%)

HOMOSALATE (10%)

OCTISALATE (5%)

OCTOCRYLENE (2.75%)

OXYBENZONE (4%)

PURPOSE

PURPOSE:

SUNSCREEN

INDICATIONS & USAGE

INDICATIONS:

HELPS PREVENT SUNBURN.

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE UP PRO 50  CONTINUOUS SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61477-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.75 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCONUT OIL (UNII: Q9L0O73W7L)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
MINERAL OIL (UNII: T5L8T28FGP)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
ISOBORNYL METHACRYLATE (UNII: 33GSY5DKCQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61477-211-26	177 mL in 1 CAN; Type 0: Not a Combination Product	02/24/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/24/2014

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)