Denise A. Mitchell says
Hello,
Please advise me how to label my products using neon liquid dyes. I know that they are not considered cosmetic grade colors I am not sure how to label them.
Thanks,
Denise
Can "Soap" be a Cosmetic &/Or A Drug?
Confused??
A single bar of soap could be:
By understanding the importance of this topic, vendors—and those considering selling—are better equipped to operate responsibly and avoid common regulatory pitfalls.
Although the main focus is soap, this information is also meant to assist newcomers who plan to sell other handmade bath and body products, including lotions, bath bombs, and related items.
Introduction
Cautiously Describe those Bubbly Bearuties–it Definest the Category
Understanding Product Differentiation in the Soap Market
Imagine walking through a craft market. At one booth, a soap vendor confidently promotes bars with moisturizing benefits, antibacterial essential oils, or antifungal properties—claims that push the product into cosmetic or even medical territory.
Just a few steps away is another booth selling products labeled simply as soap.
Most shoppers gravitate toward the first booth. After all, the seller sounds articulate, informed, and persuasive. But here’s the important question:
Are those claims being made within the legal requirements they trigger?
Image AI generated
Whether you’re buying or selling soap, it’s essential to understand how claims influence product categories and competition. Artisan soap competes with:
- Mass-Produced Soaps: Detergent-based cleansers often marketed as superior to “real soap.”
- Other Artisan Soaps: Found on platforms like Etsy, Amazon, and personal websites.
Why Claims Matter — For Sellers and Buyers Alike
Whether you’re buying soap or selling it, understanding how product claims affect classification and competition is critical. Claims don’t just influence consumer perception—they determine how a product is regulated and what standards must be met.
Artisan soap doesn’t exist in a vacuum. It competes with:
Mass-produced “soaps”
Often detergent-based cleansers marketed as gentler, more advanced, or superior to “real soap.”Other artisan soaps
Sold on platforms like Etsy, Amazon, craft markets, and individual websites—many making very different claims about what their products do.
Knowing where your product fits—and how you describe it—can mean the difference between selling soap… and unintentionally selling a cosmetic or drug.
Why This Matters
Careless wording doesn’t just blur categories—it creates unfair competition and regulatory risk. Clear, honest descriptions protect both vendors and consumers, and help keep the playing field level.
In short: how you describe those bubbly beauties matters just as much as how you make them.
The FDA Defines Soap and Cosmetics
Distinguishing Soap from a Cosmetic
HELPFUL FDA LINKS BELOW
Recognize Cosmetic Claims
- Deodorizes
- Moisturizes
- Nourishing
- Leaves the skin feeling soft
- Imparts a fragrance to the skin
To name only some
Recognize Drug Claims
- Removes impurities from the skin
- Assists with dry sensitive skin
- Supplies the skin with vitamins &/or minerals
- Has or imparts anti-bacterial, anti-fungal properties, etc
- Improves conditions like psoriasis, eczema, acne, oily skin, etc.
FDAs Offical Site Links:
I’m sure the list goes on
Soap Claims Require Compliance
Making cosmetic or medical claims about soap may seem like an easy way to stand out in a competitive market, but every claim places your product into a specific regulatory category—and each category comes with its own legal requirements.
Something as simple as describing a soap as moisturizing, antibacterial, or antifungal can shift it out of the soap category and into cosmetic or drug territory. At that point, additional regulations apply. Disclaimers, fine print, or “I didn’t know” will not protect you if your product does not comply.
As a vendor, it is your responsibility to understand and follow the requirements set by the U.S. Food and Drug Administration.
FDA Inspection and Compliance
Non-compliance with the FD&C Act can result in more than a warning. In some cases, it may open your production space and records to inspection by an FDA specialist—including an unannounced visit.
While formal Good Manufacturing Practices (GMPs) are not required for soap that makes no cosmetic or medical claims, FDA inspectors will still evaluate products for adulteration or misbranding. If issues are found, the outcome may include a cease-and-desist notice and a required compliance plan.
This is one of the primary reasons I choose to sell soap only.
Differentiating Soap Products (Without Risky Claims)
Selling plain soap for cleansing purposes does limit the types of claims you can make—but it does not limit your ability to stand out.
Instead of claims, focus on:
Quality ingredients
Skilled formulation
Transparency
Customer satisfaction
Excellent service
In the long run, honesty and consistency build trust—and trust builds a loyal customer base, even in a crowded market.
Good Manufacturing Pracices Book
A Must-Read for Cosmetic Claims
A Must-Read for Cosmetic Claims
Selling on platforms like Etsy, Amazon, or your own website while making cosmetic claims requires strict adherence to Good Manufacturing Practices (GMP)—a commitment many sellers don’t realize is a significant undertaking.
Having previously operated a licensed daycare, I’m very familiar with the level of paperwork, documentation, and regulatory oversight required to stay compliant. In many ways, compliance itself felt like a full-time job. Because of that experience, I strongly encourage anyone considering cosmetic claims to take GMP requirements seriously.
For those exploring this path, I highly recommend investing time in a Good Manufacturing Practices (GMP) guide. I purchased mine on Amazon specifically to understand what would be required if I ever chose to make cosmetic claims.
Why I Chose to Learn—But Not Claim
Although I do not attach cosmetic claims to my soap, I wanted a clear understanding of what compliance would involve. The GMP book outlines extensive requirements for documentation, organization, sanitation, record-keeping, and traceability.
Reading through it is often enough to make you pause and seriously ask whether cosmetic claims are worth the added responsibility.
If you’re naturally meticulous (like I am), you may already follow some good practices. But when it comes to cosmetic claims, “some” is not enough. Partial compliance is still non-compliance.
Understanding this upfront allows you to make informed decisions—before attaching claims that change how your products are regulated.
Prevent A Knock at Your Door by The FDA
Understanding regulations can save small business owners a great deal of unnecessary stress. A real-world example shared on Modern Soapmaking by Robin of River County Soapworks offers an important lesson:
even if your product meets the narrow definition of soap, the moment you attach cosmetic or medical claims, it is no longer regulated as soap. Instead, it becomes a cosmetic or drug under the U.S. Food and Drug Administration and the FD&C Act.
Robin’s experience highlights how easily well-intentioned sellers can cross regulatory lines—often without realizing it.
Modern Soapmaking tells Robin of River County Soapworks FDA’s story
Who Regulates What?
If you label, sell, and describe your product exclusively as soap, it does not fall under FDA cosmetic regulations. Instead, it is regulated by the Consumer Product Safety Commission (CPSC).
The CPSC has specific labeling requirements, including:
Text size
Placement
Format
Interestingly, traditional soap does not require an ingredient list under CPSC rules. That said, voluntarily listing ingredients in descending order of predominance is considered good practice and helps customers avoid allergens. Transparency and consumer safety should always be priorities—even when not strictly required.
Additionally, labeling and packaging must comply with the Fair Packaging and Labeling Act (FP&L Act), overseen by the Federal Trade Commission (FTC) and FDA, to prevent deceptive practices. Staying informed and compliant can help you avoid regulatory headaches.
If you label, sell, and describe your lusciously lathering lumps of soap exclusively as soap, you’ve met the narrow FDA’s definition; therefore, your products are regulated by the Consumer Product Safety Commission (CPSC) which has very defined labeling rules: Cosmetic Labeling Guide.
I also choose not to sell unlabeled soap, even though traditional soap is not required to carry an ingredient list. Many people avoid certain ingredients for religious, ethical, or personal reasons, and clear labeling allows them to make informed choices.
Transparency matters to me. I wouldn’t purchase a bar of soap without knowing what’s in it, and I won’t ask my customers to do so either. Clearly labeled ingredients are part of responsible manufacturing, respectful selling, and good customer care.
WEBSITE LINKS:
Made in USA and Organic Labeling
If you plan to include “organic” or “made in the USA,” there are rules for this:
Soap Queen, I’ve included some Q & A’s from the site
(click on + and – to open/close the Q & A’s)
Anne-Marie saysYou need to ask your vendor for the INCI for the product. And, small side note, if the product isn’t cosmetic grade, I don’t suggest using it in soap.
Theraisa K saysSo confusing :/ So let’s say I want to put a label on my bath fizzies, is this the correct way to list the ingredients: Sodium Bicarbonate (Baking Soda), Zea Mays (Corn) Starch, Magnesium Sulfate (Epsom Salts), Citric Acid, Water. Or would I leave out the generic terms for Baking Soda and Epsom Salts and just have their latin names? Also I read somewhere that you have to list them in descending order based on their quantity of use, is this true?
Kelsey saysHi Theraisa! In the U.S., the INCI names are not required. You only need the common name. However, you can list both to be extra careful. It’s also a good idea to list both if you are selling internationally, as the INCI names are global. If you like, you can just list INCI names. However, the common names in parentheses are helpful for people who aren’t familiar with INCI names. Also, you will want to list the ingredients from most used to least used. 🙂
Read more about how to label your products here: https://www.soapqueen.com/bath-and-body-tutorials/lip-products/labeling-your-products-lip-balm/
This book on labeling is really helpful as well: https://www.brambleberry.com/Soap-And-Cosmetic-Labeling-Book-1-Book-P3663.aspx
-Kelsey with Bramble Berry
SR says
I purchased some soap awhile back and there were not labels of ingredients at all. What can happen of they do not label their products??
Donna C. saysSoap is not considered a cosmetic by the FDA so has no requirements to be labeled IF it’s true soap (not a synthetic detergent bar) and IF there are no cosmetic claims (moisturizing or deodorant). But if it’s a syndet bar or makes a cosmetic claim, then it would have to follow the cosmetic labeling rules.
That’s my understanding from this FDA page that talks about soap:
Tara saysThanks Becky!
One other question, with me making my products at home, do I need to put my full address on the label? Kind of nervous about putting a personal address on the label :/
Thanks again!!Hi Tara!
We totally understand how putting your home address on a label can make you nervous. According to the FDA’s website, you will need to list that name of the maker of the product (yourself) as well as your address. If you have a P.O. Box or business address, you can also use that as well. I hope this helps! =)
-Becky with Bramble Berry
Michelle says
I am reading all the comments and have read your information regarding labeling and it’s great. I come with a question however. Regarding challenge testing creams, I am only beginning with my small company and do not have the money to challenge test. My cream is 100% concentrated, no water and I read on your website one of your creams is as well and so does not need any preservative. Would this hold true for any concentrated cream? Also, if we add fragrance oils/essential oils, does that change the answer?
Also, I am in the process of forming an LLC for protection purposes as well. Regarding insurance, would you still suggest purchasing cosmetic insurance as secondary protection? I am in the process of differentiating between the protections both would offer. Any suggestion would be helpful!
Thanks! 🙂
Good morning Michelle!
Could you tell me a little bit more about your recipe? Is there any other liquid like Aloe Vera or anything that could be a water-like substance in your recipe? If so, you will want to use a preservative. But, if it is more like a body butter consistency (just oils), you won’t have to. Fragrance and essential oils aren’t going to change a cream or a lotion to need (or not need) a preservative. It really boils down to if you are using water or a water-like substance in your recipe.
We always recommend getting insurance for the peace of mind of yourself and your business. Here is a great post that Anne-Marie wrote about the different types of insurance that many soapers have. I hope it helps.
Business Insurance for the Handcrafted Industry: http://www.soapqueen.com/business/business-insurance-for-the-handcrafted-industry/
-Becky with Bramble Berry
Art saysUmm I’m not sure how, but Blistex tubes use a P.O. Box. address. Maybe because the claims classify it as a OTC drug due to the ingredients. BTW the FDA website says that if it includes cocoa butter then it has active ingredients, and as another poster said, falls under much stricter rules. If it contains active ingredients, it’s considered an OTC drug. A way around this is to not use the ingredients listed with medicinal properties on the FDA website. You can’t legally claim moisturizing, treat chapped skin etc. without it being labelled an OTC drug. That’s why commercial lip balms have “Drug Facts” on the packaging. Everyone knows lip balm is not “medicine,” but that’s how they categorize it. I actually just read all this today, but you have a very good and MUCH SHORTER lol summary of cosmetic requirements. I guess it just wouldn’t apply when considered both a cosmetic and a drug… Be careful.
- Kelsey says
The difference between products that are cosmetics and drugs can be a bit confusing! For instance, products that claim to treat chapped lips or lip balms that have SPF in them are considered a drug and are regulated that way. However, moisturizing is a tricky one. It claims to beautify the skin rather than treat or cure it, so that term can be used for cosmetics! You can read more about the difference between drugs and cosmetics here: https://www.soapqueen.com/business/understanding-fda-cosmetic-vs-drug-claims/
As for cocoa butter, I don’t believe it is considered an active ingredient. According to Marie Gale, “There IS a monograph for using cocoa butter at 50% – 100% as an active ingredient for a skin or lip protectant. Using it at that rate and claiming the product actually PROTECTS the skin or lips causes the product to be a drug. In order to be marketed as such it would need to follow the regulations for Skin Protectant Drug Products for Over-The-Counter Human Use, covered in 21 CFR 347, AND the manufacturer would need to be registered with the FDA as a drug manufacturer and follow all the required good manufacturing guidelines for drug manufacture (which are in regulation).”
Read more in her blog on the subject: http://www.mariegale.com/more-on-lip-balm/
So, as long as your cocoa butter is used as a smaller amount and the lip balm isn’t marketed as a lip protectant, it should be fine. To be 100% sure I would recommend contacting the FDA! They can tell you more about cocoa butter. Find their contact information here: http://www.fda.gov/AboutFDA/ContactFDA/default.htm
Marie Gale’s book, Soap and Cosmetic Labeling, has a lot of helpful information as well: https://www.brambleberry.com/Soap-And-Cosmetic-Labeling-Book-1-Book-P3663.aspx
Also, I’m not sure why Blistex is allowed to use a PO Box! Because their products are sold as a drug they will have different regulations. For handmade cosmetics, the label will need a street address. Hope that helps! 🙂
-Kelsey with Bramble Berry
Rachel saysHi Anne-Marie,
I really appreciate this post! I try so hard to follow the FDA labeling requirements and it frustrates me that others either don’t know the regulations or choose not to follow them.I was talking with some friends over the weekend who purchased some handmade sunscreen on Etsy. I cringed on the inside because I’m not sure about claiming that a product has sun protection and marketing it as a sunscreen. If I read the Etsy policy doesn’t it seem that anything branded as sunscreen would fall into the “drug” category and not be allowed to be sold on Etsy?
Thanks,
Rachel
Amber saysYes, as far as our research has shown claiming a specific SPF is a drug claim and you have to have your product tested to ensure that the SPF is correct.
So I agree with you. Claiming that a product is a sunscreen is a drug claim and requires special labeling. It’s one of the reasons Bramble Berry doesn’t sell SPF additives, we don’t want our customers to get in trouble!
Educational & Informational Disclaimer
The information provided on this website is for educational and informational purposes only. It is intended to share general knowledge about traditional soapmaking, ingredient behavior, historical context, and manufacturing processes.
Nothing on this site is intended to diagnose, treat, cure, or prevent any disease or medical condition. The products offered are classified as soap under FDA guidelines and are not intended to affect the structure or function of the skin or body. Individual experiences and preferences may vary.
Information presented here should not be considered a substitute for professional medical advice, diagnosis, or treatment. If you have a medical condition, skin concern, or sensitivity, please consult a qualified healthcare professional before using any product.
This website may reference or link to third-party scientific, technical, or educational resources for general learning purposes. These references are provided to support transparency and encourage independent research, not as endorsements or medical guidance.
Click here to read the full disclaimer.
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Contact me:
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(479) 651-2760
I typically respond to texts almost immediately unless I’m in the middle of making soap.
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I’ve been seeing companies that make claims that their product will help with wrinkles but then on the same page says these comments have not been tested and evaluated by the FDA. Wouldn’t they need FDA approval just to be able to say this?
Hi Liz!
If the customer believes the product helps with wrinkles, even if there is a disclaimer, it is considered a drug and is regulated as such. It’s best to be very careful when labeling your product. If you intend to sell it as a cosmetic, make sure it only claims to beautify instead of treat a condition. Stick to words like skin loving and moisturizing. 🙂
-Kelsey with Bramble Berry