Is Mary Kay Inc. FDA approved?

Mary Kay Inc. holds 2 FDA-registered establishments in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Mary Kay Inc.'s drugs manufactured?

The FDA register lists Carrollton, TX; Lewisville, TX. Registered operations: finished drug manufacture, relabelling, repackaging.

What drugs does Mary Kay Inc. make?

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

Mary Kay Inc.

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

Request a quote Claim this profile

Registered sites: 2
Active NDC listings: 20
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Finished drug manufacture1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Mary Kay Inc.	1525 W Frankford Rd, Carrollton, Texas (TX) 75007, United States (USA)	Relabelling, Repackaging	3004352658187342068
Mary Kay Inc.	2613 Denton Tap Road, Lewisville, Texas (TX) 75067, United States (USA)	Finished drug manufacture	3014970187103978839

Catalogue

Drug listings by form and route

20 active NDC listings: 20 human otc drug. By marketing category: OTC MONOGRAPH DRUG 20.

Dosage form	NDCs
cream	6
kit	5
lotion	4
gel	3
liquid	1
solution	1

Route	NDCs
topical	15

Labeller name on the listing	NDCs
mary kay inc.	20

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Clear Proof Acne System	Benzoyl Peroxide and Salicylic Acid	kit	51531-8977OTC MONOGRAPH DRUG
Clear Proof Acne System The Go Set	Benzoyl Peroxide and Salicylic Acid	kit	51531-8968OTC MONOGRAPH DRUG
Clear Proof Acne Treatment Acne Medication	Benzoyl Peroxide	gel, topical	51531-9071OTC MONOGRAPH DRUG
Clear Proof Blemish Control Toner Acne Medication	Salicylic Acid	liquid, topical	51531-6743OTC MONOGRAPH DRUG
Clear Proof Clarifying Cleansing Gel Acne Medication	Salicylic Acid	gel, topical	51531-1349OTC MONOGRAPH DRUG
MKMen Advanced Facial Hydrator Sunscreen SPF 30	avobenzone, homosalate, octisalate, octocrylene, oxybenzone	lotion, topical	51531-0288OTC MONOGRAPH DRUG
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Deep	homosalate, octinoxate, oxybenzone	cream, topical	51531-2825OTC MONOGRAPH DRUG
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to Medium	homosalate, octinoxate, oxybenzone	cream, topical	51531-2823OTC MONOGRAPH DRUG
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep	homosalate, octinoxate, oxybenzone	cream, topical	51531-2824OTC MONOGRAPH DRUG
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep	homosalate, octinoxate, oxybenzone	cream, topical	51531-6620OTC MONOGRAPH DRUG
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Light	homosalate, octinoxate, oxybenzone	cream, topical	51531-2822OTC MONOGRAPH DRUG
Mary Kay Foundation Primer	avobenzone, homosalate, octisalate, octocrylene	gel, topical	51531-0850OTC MONOGRAPH DRUG
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30	Zinc Oxide	lotion, topical	51531-3253OTC MONOGRAPH DRUG
Mary Kay Satin Hands Shea Hand Sanitizer	Alcohol	solution, topical	51531-8735OTC MONOGRAPH DRUG
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30	Avobenzone/Octisalate/Octocrylene	lotion, topical	51531-7385OTC MONOGRAPH DRUG
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30	avobenzone, homosalate, octisalate, octocrylene, oxybenzone	cream, topical	51531-0549OTC MONOGRAPH DRUG
Mary Kay TimeWise Repair Volu-Firm Sampler Set	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone	kit	51531-1606OTC MONOGRAPH DRUG
Mary Kay TimeWise Repair Volu-Firm Set	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone	kit	51531-8434OTC MONOGRAPH DRUG
Mary Kay TimeWise Repair Volu-Firm The Go Set	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone	kit	51531-1614OTC MONOGRAPH DRUG
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY	Avobenzone/Octisalate/Octocrylene	lotion, topical	51531-7287OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Certified Laboratories, LLCCarrollton, TX
Micelle Laboratories IncorporatedCarrollton, TX
Swiss-American CDMO, LLCCarrollton, TX

Compare

Comparable companies in United States

Deseret Laboratories Incorporated2 sites · 858 NDC
Padagis Israel Pharmaceuticals Ltd2 sites · 236 NDC
PureTek Corporation2 sites · 178 NDC
Cosmax Usa Corporation2 sites · 142 NDC
Apotheca Company2 sites · 110 NDC
Nivagen Pharmaceuticals LLC2 sites · 106 NDC
GOJO Industries, LLC2 sites · 84 NDC
KVK-TECH, INC.2 sites · 71 NDC
Revlon Consumer Products Corporation2 sites · 61 NDC
Samsung Biologics Co., Ltd.2 sites · 57 NDC

Enquiry

Common questions

Is Mary Kay Inc. FDA approved?: Mary Kay Inc. holds 2 FDA-registered establishments in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Mary Kay Inc.'s drugs manufactured?: The FDA register lists Carrollton, TX; Lewisville, TX. Registered operations: finished drug manufacture, relabelling, repackaging.
What drugs does Mary Kay Inc. make?: 20 products are listed under Mary Kay Inc. in the openFDA NDC Directory, most often as cream; kit; 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.