NDC 61477-225

ALOE KOTE SPF 25

Octinoxate, Oxybenzone, Homosalate

ALOE KOTE SPF 25 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Aloe Care International, Llc. The primary component is Octinoxate; Homosalate; Oxybenzone.

Product ID61477-225_ce6ad9ad-b178-49da-8ad4-ff3d0eb42737
NDC61477-225
Product TypeHuman Otc Drug
Proprietary NameALOE KOTE SPF 25
Generic NameOctinoxate, Oxybenzone, Homosalate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-05-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameAloe Care International, LLC
Substance NameOCTINOXATE; HOMOSALATE; OXYBENZONE
Active Ingredient Strength7 g/100g; g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61477-225-11

7 g in 1 JAR (61477-225-11)
Marketing Start Date2019-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61477-225-11 [61477022511]

ALOE KOTE SPF 25 CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-17

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE7.4 g/100g

OpenFDA Data

SPL SET ID:12e78c53-ba19-4c8e-bd2f-8c85fccbc179
Manufacturer
UNII

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