FDA.reportPublic FDA data

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

Manufacturer
Aloe Care International, LLC
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:35:40

Label at a glance#

ProductALOE ICE SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 2.75%

OXYBENZONE 4%

OTC - PURPOSE SECTION

PURPOSE:

SUNSCREEN

INDICATIONS & USAGE SECTION

INDICATIONS:

HELPS PREVENT SUNBURN.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aloe Ice_SPF-50_SprayAloe Ice_SPF-50_Spray

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130079385668501GTIN-13: 0079385668501
EAN-13: 0079385668501
GTIN-12: 079385668501
UPC-A: 079385668501
GTIN storage (14 digits): 00079385668501		Aloe Ice_SPF-50_Spray.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61477-204-262024-02-13C16284748780-10191ceaa-6899-198a-e063-dbdaa90aec3eALOE UP - ALOE ICE SPF 50 SPRAY (61477-204)
61477-204-262023-07-28C16284748780-10191ceaa-6899-198a-e063-dbdaa90aec3eALOE UP - ALOE ICE SPF 50 SPRAY (61477-204)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-204-26ALOE ICESPF 50177 mL in 1 BOTTLE, SPRAYSPRAY1777

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61477-20461477-204-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
COCONUT OILQ9L0O73W7LIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
MINERAL OILT5L8T28FGPIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
ALCOHOL3K9958V90MIACT
DIBUTYL MALEATE4X371TMK9KIACT
ISOBORNYL METHACRYLATE33GSY5DKCQIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALOE ICE SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCe4b861d2-3680-4ed7-8650-d1d839da5ab22026-01-28WarningsExact identifier
ndc (package): 61477-204-26
ndc (product): 61477-204
ndc11 (package): 61477020426
spl id: 497ad0ff-be39-2cf7-e063-6394a90a7274
spl set id: e4b861d2-3680-4ed7-8650-d1d839da5ab2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.