How do I legally sell lip gloss?

Below are frequently asked questions and our answers to them.  We have also provided links to learn more information about each of the specific topics identified below. Feel free to contact the FDA - CFSAN - Outreach and Information Center (salesforce-sites.com) for general cosmetic questions or for specific questions regarding Modernization of Cosmetics Regulation Act of 2022 (MoCRA), please contact QuestionsAboutMoCRA@fda.hhs.gov.

1. Does FDA regulate cosmetics?

2. How do I know if my products are regulated as cosmetics, and not as drugs or some other product category?

3. Do I need to have my cosmetic products or ingredients approved by FDA?

4. What do I need to know about using color additives in cosmetics?

5. Do I need to register my cosmetic product facility or list products with FDA?

6. Can I manufacture cosmetics in my home or salon?

7. Can I label my cosmetics “natural” or “organic”?

8. Must I test my products and ingredients?

9. Using available safety data

10. Doing additional testing

11. Can I use a Post Office (P.O.) box or website for the address on the label?

12. Where can I learn more about labeling requirements?

13. What are the local requirements for starting a cosmetics business?

14. Do I need to get a license from FDA to manufacture or market cosmetics?

15. Where can I find more information on FDA requirements I need to know about?

1. Does FDA regulate cosmetics?

Yes. FDA regulates cosmetics under the Federal Food, Drug and Cosmetic Act (FD&C Act). Under MoCRA, which expanded FDA’s authority under the FD&C Act law, cosmetics must not be adulterated or misbranded. For example, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled. Any color additives they contain must be approved for the intended use, and some must be from batches certified in FDA’s own labs. Packaging and labeling must not be deceptive. If you manufacture or market cosmetics, you have a legal responsibility for the safety and labeling of your products.

To learn more, see “Resources for You: Industry” and “Cosmetics: Guidance and Regulations,” where you will find overviews of the laws, links to the laws and regulations themselves, and more.

2. How do I know if my products are regulated as cosmetics, and not as drugs or some other product category?

A product’s intended use is determined by factors such as product claims, consumer expectations, and certain ingredients. A product is a cosmetic if it is intended for uses such as cleansing the human body, making a person more attractive, or changing a person’s appearance. Here are some examples of products marketed as cosmetics:

• Makeup
• Moisturizers
• Hair dyes, permanent waves, straighteners, and removers
• Perfumes and colognes

If a product is intended to affect the way a person’s body works, or to treat or prevent disease, it’s a drug, but sometimes it is both a cosmetic and a drug depending on its claims. Drugs must meet different requirements.

Some “personal care products” are regulated by FDA as medical devices or as dietary supplements, while others, including some soaps, are regulated by the Consumer Product Safety Commission (CPSC). To learn more about these product categories, including how FDA determines a product’s intended use, see Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).

Here are some more resources:

3. Do I need to have my cosmetic products or ingredients approved by FDA?

The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market. However, cosmetics must not be adulterated or misbranded. This means that they must be safe for consumers when used according to the labeling, or as people customarily use them, and they must be properly labeled. To learn more, see Key Legal Concepts: Interstate Commerce, Adulterated, and Misbranded.

With the exception of color additives and ingredients that are prohibited or restricted by FDA regulations, you may use any ingredient in your cosmetic, as long as it does not cause the product to be adulterated in any way. You are legally responsible for making sure your cosmetics are safe and properly labeled, in compliance with all the laws and regulations that apply to them.

Remember, however, that not all “personal care products” are regulated as cosmetics under U.S. law. For example, some are regulated as drugs. If your product is a drug under U.S. law, it must meet the requirements for drugs, such as premarket approval. For more information about how some “personal care products” are regulated by FDA as medical devices, while others are regulated by the CPSC, see #2 above.

4. What do I need to know about using color additives in cosmetics?

A color additive, other than coloring materials intended for use as coal-tar hair dyes, must be approved by FDA for the intended use. These color additives are listed in regulations called “listing regulations.” Some may be used only if they are from batches certified in FDA’s own labs. Here are some resources to help you learn more: 

• Color Additives and Cosmetics — An overview
• Color Additives Permitted for Use in Cosmetics — A quick-reference table, with links to the listing regulation for each of these color additives
• Color Additive Regulations — For links to the color additive regulations themselves

5. Do I need to register my cosmetic product facility or list products with FDA?

Yes, you may need to register your facility and list your cosmetics products. Please see our Draft Guidance that describes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requirements for facility registration and product listing, and the exemptions under MoCRA for certain small businesses.

MoCRA exempts certain small businesses from facility registration and product listing.

However, such exemptions do not apply to manufacturers or facilities that manufacture or process the following cosmetic products: 

• Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use. 

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices (For ex. Class 1 and Class II Device Exemptions).

If, however, your products are drugs, or both cosmetics and drugs, they must meet the requirements for drug registration. Similarly, importers of cosmetic ingredients that are also classified as food products must meet the registration requirements of the Bioterrorism Act of 2002.

6. Can I manufacture cosmetics in my home or salon?

It’s not against the law to manufacture cosmetics in your home. Keep in mind, however, that it’s your responsibility to manufacture products in an environment that will not cause them to become adulterated.

Here are some of the ways in which a cosmetic can become adulterated:

• Color additive violations: Misuse of color additives makes a product adulterated. (See examples at Import Alerts & Refusals Involving Color Additive Violations)
• Prohibited and restricted ingredients: Violating the restrictions on the use of these substances makes a cosmetic adulterated. (See Prohibited & Restricted Ingredients in Cosmetics)
• Packaging: The composition of its container may make the contents "injurious to health," such as a lipstick packaged in a container with lead coating.
• Microbial contamination: Cosmetics are not required to be sterile, but microbial contamination can pose a health hazard, making a product adulterated. (See Microbiological Safety and Cosmetics)
• Other contaminants: Unwanted substances from a number of sources may adulterate a product, such as asbestos in talc-containing cosmetics. (See Potential Contaminants in Cosmetics)
• Any other problem that could make the product unsafe for consumers when they use it according to directions on the label, or as it is customarily used. (See the FD&C Act, Section 601)

FDA intends to conduct rulemaking as part of the implementation of MoCRA, which requires FDA to establish good manufacturing practices (GMP) that, to the extent practicable and appropriate, are consistent with national and international standards. If you manufacture homemade cosmetics or own a salon, exemption from GMP requirements may apply. For more information on GMP, please see: 

7. Can I label my cosmetics “natural” or “organic”? 

The same requirements for safety and labeling apply to all cosmetics, no matter what their source. This includes, for example, making sure that all your labeling is truthful and not misleading. 

FDA has not defined the term “natural” and has not established a regulatory definition for this term in cosmetic labeling. 

FDA also does not have regulations for the term "organic" for cosmetics. The U.S. Department of Agriculture (USDA) regulates the use of the term “organic” for agricultural products under the National Organic Program (NOP). If you have questions about the use of the term “organic,” contact USDA. Answers to some common questions about "organic" cosmetics are available on our website under “‘Organic’ Cosmetics.” 

Don’t use terms such as “natural” as part of an ingredient statement, because ingredients must be listed by their common or usual names, without additional description. 

And remember, choosing ingredients from sources you consider “organic” or “natural” is no guarantee that they are safe. You are still responsible for making sure your ingredients are safe when used according to the labeling, or as they are customarily used, no matter what kinds of ingredients you use.

8. Must I test my products and ingredients?

In general, a manufacturer, packer or distributor whose name appears on the label of a cosmetic product is required to ensure adequate substantiation of safety of their cosmetic product and to maintain records that support substantiation. Adequate substantiation of safety means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe. Animal testing is not a requirement. It’s important, however, that all data used to support the safety are derived from scientifically robust methods.

FDA does not require specific tests to demonstrate the safety of individual cosmetic products or ingredients. Nor does FDA require cosmetic companies to share their safety information with FDA prior to marketing of their products. However, if certain conditions are met, FDA can access and copy records, including safety substantiation data for cosmetic products and their ingredients. 

FDA has consistently advised manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients. Firms may substantiate safety in a number of ways. FDA has stated that "the safety of a product can be adequately substantiated through: 

1. reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and 
2. performance of any additional toxicological and other tests that are appropriate in light of such existing data and information." (Federal Register, March 3, 1975, page 8916).

Additionally, there are regulations that prohibit or restrict the use of several ingredients in cosmetic products. (See 21 CFR 700.11-700.35.)

For more resources on cosmetics safety substantiation, please see Product Testing of Cosmetics.

9. Using available safety data

Manufacturers can use relevant safety data that is already available to support the safety of their products.

Here are some examples:

• Cosmetic ingredient suppliers often have safety data on their products.
• Safety data may be published in scientific journals (sources include PubMed and ToxNet). 

The Cosmetic Ingredient Review (CIR) website has information on the safety of cosmetic ingredients that they have reviewed. (CIR is an industry-funded panel of scientific and medical experts who review the safety of cosmetic ingredients. FDA participates in CIR meetings, but does not vote, and we may agree or disagree with CIR conclusions. However, we do take CIR reviews into consideration when we evaluate cosmetic ingredient safety.)

10. Doing additional testing

You may also need to do toxicological testing to fill in any gaps in the information that’s available. Toxicology or other testing methods may be necessary to determine the safety of each ingredient and the finished product. And don’t forget microbiological safety. Cosmetics do not have to be sterile, but they must not contain any harmful microorganisms, and the number of aerobic microorganisms per gram must be low. To learn more, see “Microbiological Methods for Cosmetics.”

Many factors can affect how your product may become contaminated, including use by consumers, such as dipping one’s fingers into a jar. If you do not have the technical expertise to determine the best way to ensure that your product is protected from contamination, you may want to work with a consultant.

For more resources on cosmetics safety substantiation, please see Product Testing of Cosmetics.

11. Can I use a Post Office (P.O.) box or website for the address on the label?

A post office box or website address is not adequate for this labeling requirement.

The FD&C Act requires cosmetic labels to identify the name and place of business of the manufacturer, packer, or distributor. By regulation, this includes the street address, city, state, and ZIP code, although you may omit the street address if your firm is listed in a current city or telephone directory. You may use the main place of business instead of the actual place where the cosmetic was manufactured, packed, or distributed, unless such a statement would be misleading.

If you use the distributor’s address, you must use a phrase such as "Distributed by" or "Manufactured for," followed by that firm's name and place of business. The name of the firm must be the corporate name. See the regulation on name and place of business at 21 CFR 701.12.

12. Where can I learn more about labeling requirements?

Cosmetic labeling is not subject to premarket approval by FDA. It’s your responsibility to make sure your labeling meets all requirements. For specific labeling questions, please contact the FDA - CFSAN - Outreach and Information Center (salesforce-sites.com) or for specific questions regarding Modernization of Cosmetics Regulation Act of 2022 (MoCRA), please contact QuestionsAboutMoCRA@fda.hhs.gov.

Here are some useful resources:

• Cosmetic Labeling and Label Claims: An overview to help you get started
• Cosmetic Labeling Guide: For step-by-step help that answers many common questions
• Cosmetic Labeling Regulations: For links to the full text of the regulations that apply to cosmetic labeling

Some cosmetic labeling requirements are regulated by other federal agencies. For example, the U.S. Federal Trade Commission regulates claims of “Made in USA.” Other country of origin labeling is regulated by U.S. Customs and Border Protection (see “Chapter 13-Country of Origin Marking”).

You may wish to work with a labeling consultant. FDA, as a government agency, does not provide referrals to private consultants.

13. What are the local requirements for starting a cosmetics business?

You will need to contact your state and local authorities for that information. The Small Business Administration can also help.

14. Do I need to get a license from FDA to manufacture or market cosmetics?

FDA does not license cosmetics firms. However, state or local authorities may require licensing or have other requirements you need to know about. You will need to contact your state or local authorities directly. Again, the Small Business Administration may be able to help.

15. Where can I find more information on FDA requirements I need to know about?

See “ Resources for You: Industry" for a list of resources for members of the cosmetics industry, large and small. You will find information on labeling, color additives, imports, exports, other agencies you need to know about, links to the laws and regulations, and more.

 

 

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If you’re looking for a side hustle that pulls together your do-it-yourself skills and your creativity, look no further than a lip gloss business.

Is Selling Lip Gloss Profitable?

Selling lip gloss has three key things working in its favor.

First, startup costs can be low. Lip gloss startup kits can be less than $100 if you know where to look, and those kits come with everything you need to get your private label up and running.

Note that you’ll pay more money if you’re looking for higher quality products, but even then, the cost to profit ratio is reasonable.

Second, creating your own lip gloss is a relatively easy skill to learn. You don’t have to pay for classes, and usually, you’ll get it right on your first or second attempt meaning there’s no wasted supply.

Third, the lip gloss business is a growing industry.

According to Grand View Research, the lip care industry reached an $820 million valuation in 2020. Grand View Research projects that the industry will jump to $1.17 billion by 2025. In other words, sales are trending up.

Why Is The Lip Care Industry Trending?

One of the reasons the lip care industry is growing is that people are looking for more variety.

According to the Grand View Research report, a couple of key changes are occurring in the industry.

For one thing, consumer demand is changing. People are now looking for natural components in their lip care products, including beeswax, essential oils, aloe vera extract, green tea extract, and shea butter, to name a few.

People are also looking for something more in their lip care products, such as sun protection.

Also, the market is expanding. Men are starting to look for personal care products, including lip care products.

These changes are things that you want to consider as you start to create and grow your lip gloss brand.

 

Homemade Lip Gloss Business Types

One of the great things about the lip gloss business is choosing to create a type of gloss that speaks to you.

Makeup brand L’Oreal has a breakdown of the types of lip gloss you can create for your brand, including:

• Sheer Lip Gloss – Sheer lip glosses “…often provide a light wash of color, or are clear, making them perfect for topping off a lipstick that packs a more colorful punch.”
• Pigmented Lip Gloss – “Free of shimmer, but just as shiny as any other lip gloss, [pigmented lip glosses] provide bold color that isn’t quite as long-lasting as a lipstick.”
• Shimmer Lip Gloss – “Packed with fine-milled shimmer, [the shimmer lip gloss] type of lip gloss was an early 2000s staple.”
• Glitter Lip Gloss – Glitter lip gloss is a little chunkier than shimmer lip gloss, but it also has a lot more sparkle.
• Matte Lip Gloss – No shine, just a matte finish.

Things You Need To Start A Lip Gloss Business

Once you’ve decided what type of lip gloss you’re going to create, it’s time to gather the ingredients. The Naturally Handcrafted blog says you will need the following:

• Grapeseed Oil or Olive Oil;
• Coconut Oil;
• Cocoa Butter (If you want a chocolate flavor to your lip gloss) or Shea Butter;
• Beeswax;
• Vitamin E Pills (Should be D-alpha-tocopherol Vitamin E which is natural);
• Lip Gloss Tubes/Containers;
• Mica Powder (Color will depend on what color you want to make your lip gloss);
• Essential Oils (Scent will depend on what you want your lip gloss to smell like).

You may also want a double boiler, though you can also use a glass measuring cup and a pot of water to get the same result.

Naturally Handcrafted also has a recipe and step-by-step instructions to help get you started on your lip gloss journey. You can find it here.

Create Your Own Lip Gloss Line

Now that you have your lip gloss made, you’re ready to create your brand.

Possible Names For Your Lip Gloss Line

The first thing you need to do is come up with a name for your lip gloss brand. If you’re stumped, there is plenty of help out there.

The marketing brand agency Soocial brainstormed and created a list of 469 potential names for a lip gloss brand. While some of the names may already be taken, you’re sure to find one that you love.

The site Biz Name Wiz has created a list of more than 1,000 other potential names.

When you find a name you like, Google it. If no one has it, snag it for yourself.

Legal Requirements For Starting A Lip Gloss Line

The Food and Drug Administration (FDA) is the federal agency that oversees the cosmetics industry. While you are not required to register your lip gloss line with the FDA before putting it on the market, you must work within the FDA’s guidelines.

Guidelines include making sure that your cosmetics are unadulterated and are not misbranded. They must be appropriately labeled, with all of the ingredients listed. If you add color additives to your the additive must be FDA approved, and you must use it as it was intended.

The FDA has pulled together a Q&A for people looking to sell homemade cosmetics. I suggest you read it before you start labeling and selling your products. You can find it here.

Do I Need A Business License To Sell Lip Gloss?

In addition to the rules put in place by the FDA, you also need to take into account the basic business needs of your new cosmetic line.

For example, do you need a business license? Some states will require you to have a business license while others will not. Usually, the answer depends on whether or not the state collects sales tax.

If you need more guidance, I looked into the issue in this post here.

Do I Need Insurance To Sell Lip Gloss?

The blog Modern Soapmaking has tackled this issue. While, the site specializes in soap, it’s also dabbled in lip gloss and balm as well. The bottom line, you need product liability insurance.

“Product liability insurance protects you from claims made against you as the manufacturer and seller of your products, including soap, lotions, lip balm, and more. It’s a common misunderstanding that if you formulate your products correctly, you don’t need product liability insurance because nothing can go wrong,” writes Modern Soapmaking.

Get insurance. Don’t stop your business before it starts going.

Branding Your Own Lip Gloss Line

With the legal all sorted out, you now need to consider branding your lip gloss business. You need to create a logo that people will associate with your business.

You will also need to create stickers that you will apply to your lip gloss. These stickers will include your company logo, all of the ingredients in the lip gloss as well as other requirements from the FDA. Again, if you have not read the FDA Q&A, read it!

You can find it here.

Where to Sell Your Homemade Lip Gloss

With your lip gloss all packaged and ready to go, you now need to find some customers.

Locally

You can choose to sell your lip gloss locally. That means you visit local beauty shops, talk to fellow crafters and attend local events to get the word out about your brand.

The benefit of selling locally is that you’re building a grassroots effort. You’re meeting personally with your clients and you’re getting immediate feedback on your brand and its products.

The downside is, building a brand like this takes a lot of time.

Online

Your other option is to sell your products online. For a little extra, you can create a website and an online store and then market your brand through social media such as Facebook, Instagram and Pinterest.

If you’re not sure how to get a shop started online, then turn to a ready-made marketplace like Etsy to sell your products.

Hybrid

There is also the hybrid option, which can offer the best of both worlds, but also requires more work for you as the small business owner. You can create an online shop, but also attend local events to get the word out about your product.

Conclusion

Whether you sell online, locally or both, a lip gloss business can be a very fulfilling and profitable side hustle.

Your own lip gloss line does not cost a lot of money to start and it’s fairly easy to learn. As you get better and your sales increase, you can increase your production to match.

Like many of the small businesses we feature a lip gloss business can be as much or as little as you want. It all depends on how you fit it into your lifestyle.

 

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