Skincare and Soap Labeling: MoCRA 2024 Update for Small Business

If you make soap, lotion, serums, or any other personal care products, 2022's Modernization of Cosmetics Regulation Act (MoCRA) changed the regulatory landscape in ways that are still rippling through the small business world.

Here's what MoCRA actually requires, what it means for your labels, and how to stay compliant without needing a regulatory consultant.

What Is MoCRA?

The Modernization of Cosmetics Regulation Act of 2022 is the first major overhaul of cosmetics regulation in the US since 1938. It gives the FDA significantly more authority over cosmetic products — including labeling, safety, and facility registration.

For small soap and skincare makers, the key new requirements are:

• Facility registration with the FDA
• Product listing through the FDA's electronic system
• Serious adverse event reporting
• Safety substantiation — having documented evidence your products are safe
• Fragrance allergen labeling (phased implementation)

Facility Registration Under MoCRA

Any business that manufactures or processes cosmetic products must register its facility with the FDA.

Timeline:

• Large companies (over $1B in annual sales): registered by December 29, 2023
• Small businesses (under $1M in cosmetic sales): December 29, 2025
• Very small businesses (between $1M–$50M): phased registration schedule

If you're a micro-business — selling at farmers markets, craft fairs, or through a small online store — you may qualify for the small business exemption. But "small" still means under $1 million in annual cosmetic sales, so many growing businesses will eventually hit this threshold.

What facility registration means:

You register through FDA's Cosmetics Direct system. You provide your business information, the types of cosmetics you make, and the responsible person contact. This is separate from drug registration — pure cosmetics go through Cosmetics Direct.

Product Listing Requirements

Under MoCRA, cosmetic products must be listed with the FDA, including:

• Product name and category
• Responsible person information
• Ingredients list (using INCI nomenclature)
• Any applicable professional-use designation

This is different from pre-market approval. You're not getting FDA approval for your products — you're registering their existence. Small businesses have the same phased timeline as facility registration.

What's Changed for Labels Themselves

MoCRA brought one significant label change that affects small makers:

Fragrance Allergen Labeling

The EU has required disclosure of 26 specific fragrance allergens on cosmetic labels for years. MoCRA directs the FDA to establish a similar system for the US.

The FDA is still developing the specific regulations, but expect a requirement to disclose fragrance allergens (above certain concentration thresholds) on US cosmetic labels within the next few years. This will affect most soap and skincare makers who use fragrance oils.

What to do now: Know what's in your fragrance oils. Request SDS (Safety Data Sheets) from your fragrance supplier. When the FDA finalizes the allergen list, you'll need to add those ingredients to your label.

Current Soap Label Requirements (What You Need Now)

Regardless of MoCRA, your soap and skincare labels must already comply with existing FDA cosmetic labeling rules:

What must be on every cosmetic label:

Principal Display Panel (front):

• Product identity (what it is: "Bar Soap," "Face Serum")
• Net weight or volume — in both US and metric units

Information Panel (back or side):

• Manufacturer/distributor name and address
• Ingredients list in INCI format, descending order by predominance
• Any required warnings

The soap vs. cosmetic distinction

True soap (made with saponified fats/oils, cleaned only by the mechanism of soap) can be regulated differently than other cleansing products. If you call it "soap" and it meets the FDA's definition of soap, it may fall under CPSC jurisdiction rather than FDA cosmetics regulation — which means different labeling rules.

Most commercial "soap" products (including many handmade bars with moisturizing claims) are technically classified as cosmetics. If you make claims beyond cleaning ("moisturizes," "softens skin"), it's a cosmetic.

Specific Label Requirements by Product Type

Bar soap / liquid soap

• Product name, net weight, ingredients (INCI), manufacturer address
• If cosmetic: full cosmetic label requirements apply
• If drug (antibacterial claims): drug labeling required

Lotion, cream, serum

• Full FDA cosmetic label requirements
• INCI ingredients list mandatory
• Net weight in both units
• Manufacturer name and address

Exfoliants and scrubs

• Same as above
• If making any active ingredient claims: may be drug territory

Lip products

• Cosmetic label requirements
• If SPF: must comply with OTC drug labeling (Supplement Facts panel, drug facts panel)

Safety Substantiation

MoCRA requires that cosmetics be "adequately substantiated for safety" before being marketed. For small makers, this means having documented evidence your products are safe — typically:

• Ingredient safety data (INCI database, CIR reports)
• Patch testing documentation
• Manufacturing process documentation

You don't need to submit this to the FDA, but you need to have it. If the FDA ever audits you or a consumer reports an adverse event, this documentation matters.

Adverse Event Reporting

MoCRA requires manufacturers to report serious adverse events (events requiring medical treatment, hospitalization, or involving severe reactions) to the FDA within 15 business days.

For small businesses, this is a new obligation. If a customer contacts you with a serious reaction to your product, you have a reporting requirement.

The Bottom Line for Small Makers

MoCRA is phased — most small soap and skincare makers have until late 2025 to register their facilities and list products. But it's worth starting now:

1. Audit your current labels against existing FDA cosmetic requirements
2. Request ingredient SDS sheets from all your fragrance and ingredient suppliers
3. Set up your FDA Cosmetics Direct account and register when your deadline hits
4. Document your safety data for every product you sell

The fragrance allergen requirements will eventually affect your labels — start gathering that data now so the transition isn't a scramble.

If you're producing at any real volume, consistent professional labels matter too. A semi-automatic labeler keeps your label placement consistent across every bottle, which matters both for shelf appeal and for label compliance (information panel placement requirements).

How We Can Help You

Zap Labeler builds semi-automatic machines for exactly the kind of small-batch skincare and soap operations MoCRA affects most. Consistent label placement across every unit is both a compliance asset and a retail presentation win. Take a look at what we offer for your container type.

See our semi-automatic labeling machines