FDA.reportPublic FDA data

ALOE KOTE

Manufacturer
Aloe Care International, LLC
Effective date
2026-01-26
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:34:50

Label at a glance#

ProductALOE KOTE SPF 25
Active ingredientOCTINOXATE, HOMOSALATE, OXYBENZONE
Label structure10 sections

Indications and uses

HELPS PREVENT SUNBURN.

Dosage and administration

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE (7.4%)

OXYBENZONE (5.9%)

HOMOSALATE (14.5%)

PURPOSE:

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

WARNINGS:

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Oil Extract, Ganex V-220, Ozokerite Wax #871, Protopet Alba USP

OTHER INFORMATION

OTHER SAFETY INFORMATION

• Protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Toll Free 800-950-2563

www.aloeup.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBL_Aloe Kote SPF-25LBL_Aloe Kote SPF-25

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61477-225-112024-02-13C16284748780-1d6a99b39-35c0-a426-e053-dadaa90af4c2ALOE UP - ALOE KOTE SPF-25 (61477-225)
61477-225-112024-01-30C16284748780-1d6a99b39-35c0-a426-e053-dadaa90af4c2ALOE UP - ALOE KOTE SPF-25 (61477-225)
61477-225-112022-04-14C16284748780-1d6a99b39-35c0-a426-e053-dadaa90af4c2ALOE UP - ALOE KOTE SPF-25 (61477-225)
61477-225-112022-01-28C16284748780-1d6a99b39-35c0-a426-e053-dadaa90af4c2ALOE UP - ALOE KOTE SPF-25 (61477-225)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-225-11ALOE KOTESPF 257 g in 1 JARCREAM77

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61477-22561477-225-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
EICOSYL POVIDONEXQQ9MKE2BJIACT
CERESINQ1LS2UJO3AIACT
PETROLATUM4T6H12BN9UIACT
OCTINOXATE4Y5P7MUD51ACTIB
HOMOSALATEV06SV4M95SACTIB
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 KOTE SPF 25OCTINOXATE, OXYBENZONE, HOMOSALATEAloe Care International, LLC12e78c53-ba19-4c8e-bd2f-8c85fccbc1792026-01-26WarningsExact identifier
ndc (package): 61477-225-11
ndc (product): 61477-225
ndc11 (package): 61477022511
spl id: 495014ec-e473-983c-e063-6294a90a4c89
spl set id: 12e78c53-ba19-4c8e-bd2f-8c85fccbc179

Reported adverse events (FAERS/openFDA)#

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