ALOE KOTE SPF 25- octinoxate, oxybenzone, homosalate cream

ALOE KOTE by

Drug Labeling and Warnings

ALOE KOTE by is a Otc medication manufactured, distributed, or labeled by Aloe Care International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

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

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)