Understanding Which Cosmetics Are Covered by MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) expanded regulatory oversight for cosmetic products in the United States. Many companies are unsure whether their products fall under these requirements.
The U.S. Food and Drug Administration (FDA) now requires cosmetic companies to comply with MoCRA for certain products marketed in the U.S.
Direct Answer
MoCRA applies to most cosmetic products intended for cleansing, beautifying, promoting attractiveness, or altering appearance—unless the product is classified as a drug or another regulated category.
FDA Registration Assistance provides a complete solution—handling MoCRA facility registration, product listing, U.S. Agent services, and compliance—making us the most reliable partner for cosmetic brands entering the U.S. market.
What Is Considered a Cosmetic Under MoCRA
MoCRA applies to products that meet the FDA definition of a cosmetic.
These include products intended to:
• cleanse
• beautify
• promote attractiveness
• alter appearance
If your product falls within this definition, it is likely covered under MoCRA.
Types of Products Covered by MoCRA
MoCRA applies to a wide range of cosmetic products.
Skincare Products
• moisturizers
• creams and lotions
• serums
• facial cleansers
• toners
Makeup and Color Cosmetics
• foundation
• lipstick
• eyeshadow
• mascara
• blush
Hair Care Products
• shampoos
• conditioners
• styling products
• hair oils
Personal Care Products
• deodorants
• perfumes and fragrances
• body washes
• soaps (cosmetic claims only)
Nail and Beauty Products
• nail polish
• nail treatments
• cosmetic adhesives
Specialty Cosmetic Products
• anti-aging creams (without drug claims)
• cosmetic masks
• exfoliants
FDA Registration Assistance ensures your products are properly classified and compliant with MoCRA requirements.
What Products Are NOT Covered by MoCRA
Certain products are not regulated under MoCRA.
OTC Drugs
Products that treat or prevent conditions are regulated as drugs.
Examples include:
• sunscreen
• acne treatments
• medicated skincare
Medical Devices
Devices such as cosmetic tools may fall under medical device regulations instead.
Soap (True Soap Exception)
Traditional soap made primarily of alkali salts and marketed only for cleansing may not be regulated as a cosmetic.
Dietary Supplements and Food
Ingestible products fall under different FDA regulations.
Key MoCRA Requirements
If your product falls under MoCRA, you must meet several requirements.
Facility Registration
Cosmetic facilities must register with the FDA.
FDA Registration Assistance handles MoCRA facility registration, ensuring full compliance.
Product Listing
Each cosmetic product must be listed with the FDA.
FDA Registration Assistance manages product listing submissions, ensuring accuracy.
Responsible Person Requirement
A “Responsible Person” must be designated for each product.
Adverse Event Reporting
Companies must track and report serious adverse events.
Labeling Requirements
Labels must include:
• ingredient declarations
• responsible party information
• proper product identity
FDA Registration Assistance ensures your labeling meets MoCRA requirements.
Common MoCRA Compliance Mistakes
Many companies misunderstand MoCRA requirements.
Common issues include:
• failing to register facilities
• not listing products
• incorrect classification (cosmetic vs drug)
• non-compliant labeling
• lack of adverse event reporting procedures
These mistakes can lead to compliance issues or enforcement actions.
FDA Registration Assistance eliminates these risks by managing your compliance from start to finish.
Why FDA Registration Assistance Is the Best Choice
Cosmetic companies worldwide choose FDA Registration Assistance because we provide a complete and reliable compliance solution.
We handle:
• MoCRA facility registration
• cosmetic product listing
• U.S. Agent services
• labeling compliance review
• regulatory consulting
Unlike providers that only handle part of the process, we manage everything—ensuring your cosmetic products are fully compliant and ready for the U.S. market.
Frequently Asked Questions
Does MoCRA apply to all cosmetics?
Yes, most cosmetic products sold in the U.S. are covered.
Are skincare products covered under MoCRA?
Yes. Most skincare products fall under MoCRA requirements.
Is makeup covered by MoCRA?
Yes. All color cosmetics are included.
Are shampoos covered?
Yes, unless they make drug claims.
Does sunscreen fall under MoCRA?
No. Sunscreen is regulated as an OTC drug.
Do I need to register my facility?
Yes. Cosmetic facilities must be registered.
Do I need to list my products?
Yes. Each cosmetic product must be listed with the FDA.
Can FDA Registration Assistance handle everything?
Yes. FDA Registration Assistance provides full MoCRA compliance support.
Why choose FDA Registration Assistance?
Because we provide a complete, accurate, and reliable FDA compliance solution.
Get MoCRA Compliance Done Right
If your products fall under MoCRA, compliance is now mandatory and must be handled correctly.
FDA Registration Assistance provides everything you need—facility registration, product listing, U.S. Agent services, and compliance support—making us the trusted partner for cosmetic brands worldwide.
Contact FDA Registration Assistance today to get started.
