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NDC 61477-0225-11 ALOE KOTE 14.5; 7.4; 5.9 g/100g; g/100g; g/100g Details

ALOE KOTE 14.5; 7.4; 5.9 g/100g; g/100g; g/100g

ALOE KOTE is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Aloe Care International, LLC. The primary component is HOMOSALATE; OCTINOXATE; OXYBENZONE.

Product Information

NDC	61477-0225
Product ID	61477-225_dc93bde0-db9f-08a6-e053-2a95a90a77a5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ALOE KOTE
Proprietary Name Suffix	SPF 25
Non-Proprietary Name	OCTINOXATE, OXYBENZONE, HOMOSALATE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	14.5; 7.4; 5.9
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	HOMOSALATE; OCTINOXATE; OXYBENZONE
Labeler Name	Aloe Care International, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 61477-0225-11 (61477022511)

Pricing Information	N/A
NDC Package Code	61477-225-11
Billing NDC	61477022511
Package	7 g in 1 JAR (61477-225-11)
Marketing Start Date	2019-05-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 12e78c53-ba19-4c8e-bd2f-8c85fccbc179 Details

ACTIVE INGREDIENTS:

OCTINOXATE (7.4%)

OXYBENZONE (5.9%)

HOMOSALATE (14.5%)

PURPOSE:

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

DIRECTIONS:

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.

SPL UNCLASSIFIED SECTION

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

WARNINGS:

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

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

OTHER INFORMATION

• Protect this product from excessive heat and direct sun

Questions or comments?

Toll Free 800-950-2563

www.aloeup.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE KOTE SPF 25

octinoxate, oxybenzone, homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61477-225
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.4 g in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	14.5 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.9 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61477-225-11	7 g in 1 JAR; Type 0: Not a Combination Product	05/17/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/17/2019

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)

Revised: 4/2022

Document Id: dc93bde0-db9f-08a6-e053-2a95a90a77a5

Set id: 12e78c53-ba19-4c8e-bd2f-8c85fccbc179

Version: 5

Effective Time: 20220413