ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN- octinoxate and oxybenzone spray 
Aloe Care International, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS:

OCTINOXATE (2%)

OXYBENZONE (2%)

PURPOSE:

SUNSCREEN

INDICATIONS:

HELPS PREVENT SUNBURN.

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.

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.

Other Ingredients:

ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, ALOE BARBADENSIS EXTRACT ASCORBIC ACID (VITAMIN C), C12-15 ALKYL BENZOATE, CASTOR OIL, COCOS NUCIFERA (COCONUT) OIL, FRAGRANCE, MINERAL OIL (PARAFFINUM LIQUIDUM), RETINYL PALMITATE (VITAMIN A), SD ALCOHOL 40-B (ALCOHOL DENAT.), TOCOPHERYL ACETATE (VITAMIN E)

Aloe Up SPF 4 Tanning Oil Spray

ALOE UP DARK TANNING OIL SPF 4  CONTINUOUS SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61477-212
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2   in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) 
ASCORBIC ACID 
C12-15 ALKYL BENZOATE 
CASTOR OIL 
ALOE VERA LEAF 
COCONUT OIL 
MINERAL OIL 
VITAMIN A PALMITATE 
ALCOHOL 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61477-212-26177 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/24/2014
Labeler - Aloe Care International, LLC (938242187)
Registrant - Aloe Care International, LLC (938242187)

Revised: 2/2014
 
Aloe Care International, LLC