ALOE ICE SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray 
Aloe Care International, LLC

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ALOE UP - ALOE ICE SPF 50 SPRAY (61477-204)

ACTIVE INGREDIENTS:

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 2.75%

OXYBENZONE 4%

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:

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

Aloe Ice_SPF-50_Spray

ALOE ICE  SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61477-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.75 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61477-204-26177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/24/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/24/2014
Labeler - Aloe Care International, LLC (938242187)

Revised: 2/2024
Document Id: 114a10fe-387c-0681-e063-6294a90a162d
Set id: e4b861d2-3680-4ed7-8650-d1d839da5ab2
Version: 6
Effective Time: 20240213
 
Aloe Care International, LLC