Is KOS America, Inc. FDA approved?

KOS America, Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does KOS America, Inc. make?

3 products are listed under KOS America, Inc. in the openFDA NDC Directory, most often as cream; gel; lotion. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

KOS America, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 3
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human otc drug. By marketing category: OTC MONOGRAPH DRUG 3.

Dosage form	NDCs
cream	1
gel	1
lotion	1

Route	NDCs
topical	3

Labeller name on the listing	NDCs
kos america, inc.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY	AVOBENZONE, OCTINOXATE, OCTISALATE	cream, topical	66820-0500OTC MONOGRAPH DRUG
DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE	lotion, topical	66820-0600OTC MONOGRAPH DRUG
SEKKISEI HERBAL UV DEFENSE gel	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	gel, topical	66820-0400OTC MONOGRAPH DRUG

Enquiry

Common questions

Is KOS America, Inc. FDA approved?: KOS America, Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does KOS America, Inc. make?: 3 products are listed under KOS America, Inc. in the openFDA NDC Directory, most often as cream; gel; lotion. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.