When Handmade Skincare Crosses Into Regulated Claims

Sunscreen, Diaper Rash Cream, Eczema Treatments & Bug Repellents: Why the Words on a Handmade Product Matter

Walk through almost any farmers market or craft show today and you’ll find an incredible variety of handmade personal-care products.

There are beef tallow balms, herbal salves, magnesium creams, essential-oil blends, zinc balms, goat milk lotions, botanical face creams and dozens of other products inspired by traditional ingredients and old-fashioned approaches to skincare.

As a handmade company ourselves, we think there is something special about that.

Naturally Lathered Tallow Co. was built around an appreciation for traditional ingredients such as beef tallow and goat milk. We also believe small makers have an opportunity to offer something increasingly difficult to find in mass-market retail: transparency, craftsmanship and a genuine connection between the person making a product and the person using it.

But handmade doesn’t mean anything goes.

There is an important side of personal care that customers rarely see from the other side of a market table:

The words used to sell a product can matter almost as much as the ingredients inside it.

A balm can be a cosmetic.

A balm making certain claims may be considered a drug.

A product containing essential oils can be a cosmetic or fragrance product.

Market that product as something that repels mosquitoes, however, and an entirely different federal agency may become relevant.

And a handmade balm containing zinc oxide doesn’t automatically become a tested sunscreen simply because zinc oxide can be an active ingredient in sunscreen.

Understanding those distinctions helps explain why responsible makers sometimes seem surprisingly cautious about what they print on a label or say in an advertisement.

First: What Actually Makes Something a Cosmetic?

Under U.S. law, cosmetics generally include products intended for purposes such as cleansing, beautifying, promoting attractiveness or altering appearance without affecting the body’s structure or functions.

That includes many familiar products: creams, lotions, shampoos, perfumes, makeup and similar personal-care products.

An important misconception is that FDA must approve every ordinary cosmetic before it reaches a store shelf.

Generally, it doesn’t.

With limited exceptions such as certain color additives, cosmetics do not go through an FDA premarket approval process simply because they are cosmetics.

That does not mean cosmetics are “unregulated.”

Cosmetics marketed in the United States remain subject to federal law. They cannot be adulterated or misbranded, and companies are responsible for the safety and proper labeling of the products they sell.

Federal oversight of cosmetics has also changed significantly with the Modernization of Cosmetics Regulation Act of 2022, commonly called MoCRA, which FDA describes as the most significant expansion of its authority over cosmetics since the Federal Food, Drug, and Cosmetic Act was enacted in 1938.

Depending on the business and product, requirements or exemptions may apply differently, particularly to certain qualifying small businesses.

The takeaway for consumers is simpler:

“FDA doesn’t pre-approve most cosmetics” is not the same thing as “cosmetics aren’t regulated.”

When Does a Cosmetic Become a Drug?

This is where things get particularly interesting.

FDA explains that whether something is considered a cosmetic, drug, or sometimes both depends significantly on its intended use.

A company can help establish intended use through the claims it makes.

Consider a hypothetical handmade balm.

If it is marketed to:

• moisturize dry-feeling skin,
• soften rough areas,
• condition the skin, or
• improve the appearance of dryness,

those are generally cosmetic-style claims.

Now imagine essentially the same jar being advertised as something that:

• treats eczema,
• heals psoriasis,
• treats a fungal infection,
• relieves arthritis pain,
• treats acne, or
• prevents a disease.

Those aren’t simply stronger adjectives for moisturization.

They communicate that the product is intended to treat or prevent disease or otherwise affect the body’s structure or functions—territory that can cause a product to meet the legal definition of a drug.

That distinction isn’t unique to handmade businesses. It applies across the personal-care industry.

And it leads to one of the most important principles consumers can understand when evaluating handmade skincare:

An Ingredient Is Not a Claim

Individual ingredients can have fascinating histories and properties.

There may be scientific literature about them. They may have been used traditionally for generations. Some may even be active ingredients used in regulated drug products.

But the presence of an ingredient does not automatically prove what a particular finished formulation will do.

That distinction becomes especially obvious with zinc oxide.

“It Contains Zinc Oxide” Does Not Automatically Mean “It’s Sunscreen”

Zinc oxide is familiar to many consumers because it is used as an active ingredient in mineral sunscreen products.

That can lead to an understandable assumption:

If a handmade balm contains zinc oxide, doesn’t it automatically provide an SPF?

That’s not how sunscreen claims work.

In the United States, products making sunscreen claims are regulated as over-the-counter drug products. FDA maintains specific requirements concerning OTC sunscreen products, including labeling and effectiveness testing.

Even cosmetics and moisturizers marketed with SPF or broad-spectrum sun-protection claims fall under sunscreen drug requirements.

That means an SPF value isn’t something a maker should simply estimate from a recipe.

Adding a certain percentage of zinc oxide to a balm does not, by itself, establish that the finished product is SPF 15, SPF 30 or SPF 50.

Finished-product performance matters.

How particles are dispersed matters.

The formulation matters.

And testing matters.

FDA’s sunscreen framework includes specific effectiveness-testing requirements associated with SPF and broad-spectrum labeling.

That is why Naturally Lathered Tallow Co. does not simply formulate a zinc-containing balm, calculate what we think its SPF “should” be and print that number on a label.

Sun protection is too important for guesswork.

Consumers deserve to know that when they purchase something labeled with an SPF value, that number is more than a maker’s assumption based on an ingredient list.

What About “Natural Sunscreen”?

The word natural doesn’t create a separate regulatory category that allows a business to bypass sunscreen requirements.

A balm can contain tallow.

It can contain beeswax.

It can contain botanical oils.

It can contain zinc oxide.

Those ingredients don’t make federal sunscreen requirements disappear if the finished product is marketed with sunscreen claims.

This is an important distinction in a marketplace where terms such as “natural sun balm,” “homemade sunscreen” and “non-toxic SPF” can sound reassuring.

Consumers should still ask a basic question:

What exactly is this finished product claiming to do?

Diaper Rash Cream Is Another Good Example

Parents understandably want gentle products for their babies, and handmade baby products have become increasingly popular.

There is nothing inherently unusual about formulating a gentle cosmetic balm intended to condition or moisturize skin.

But treating or preventing diaper rash is not merely a moisturization claim.

FDA’s OTC regulatory materials specifically address diaper-rash products within the skin-protectant drug framework.

That means there’s an important distinction between a cosmetic baby balm and a product marketed specifically to treat or prevent diaper rash.

Again, the ingredient itself isn’t the entire issue.

Zinc oxide can exist in different types of formulations.

The important question is what the finished product is, how it is labeled and what the manufacturer tells consumers it is intended to do.

This is why terminology matters.

“Baby balm” and “diaper-rash treatment” may sound like neighboring phrases to a shopper.

Regulatorily, they can carry very different implications.

The Same Problem Appears With Eczema, Psoriasis and Acne

This is another area where handmade skincare marketing can quickly become confusing.

A customer might use a moisturizer and genuinely believe that it made their eczema-prone skin feel dramatically better.

Their experience is real to them.

But there is an important difference between a customer describing their personal experience and a manufacturer turning that experience into a therapeutic promise.

A company saying:

“This rich balm moisturizes dry-feeling skin”

is very different from saying:

“This balm treats eczema.”

Likewise:

“Helps improve the appearance of dry skin”

is different from:

“Heals psoriasis.”

And:

“Cleanses oily or blemish-prone skin”

is different from:

“Treats acne.”

FDA specifically recognizes that certain claims can cause a product to be regulated as a drug even when the business otherwise presents it as a cosmetic.

This is one reason reputable cosmetic marketing can sometimes sound less dramatic than social-media marketing.

The less dramatic wording may be intentional.

Customer Testimonials Don’t Necessarily Create a Loophole

This deserves attention because testimonials are everywhere.

Imagine a customer writes:

“This completely cured my eczema!”

A business may understandably be thrilled that the customer loves the product.

But there’s a difference between allowing customers to share experiences and a manufacturer actively adopting a therapeutic statement as part of its own marketing.

The broader lesson is that businesses need to consider their overall presentation—not merely the ingredient panel on the jar.

Product names, websites, advertisements, social posts, directions for use and promotional materials can all contribute to how a product’s intended use is communicated.

Putting a general disclaimer somewhere on a website should not be treated as permission to make unlimited therapeutic claims everywhere else.

Bug Repellent Is Different Again

Here’s where the regulatory landscape takes another turn.

When a product is marketed as repelling mosquitoes, ticks or other pests, the primary federal regulator generally isn’t FDA.

It’s the U.S. Environmental Protection Agency.

EPA regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA.

Most skin-applied insect repellents must be registered with EPA before they can be marketed.

However, there is an important exception that sometimes gets oversimplified online.

EPA provides an exemption from federal registration for certain qualifying minimum-risk pesticides.

That doesn’t mean:

“It’s made with essential oils, therefore it’s exempt.”

To qualify for the federal minimum-risk exemption, the product must satisfy the applicable conditions established by EPA, including requirements concerning ingredients, labeling and claims. State requirements may also apply even when a product qualifies for the federal exemption.

That’s a much more accurate explanation than simply saying natural bug repellents are either universally legal or universally prohibited.

“Citronella Is in It” Isn’t the Whole Analysis

This brings us back to the same principle:

An ingredient is not a claim.

Someone can put citronella, cedarwood or another aromatic ingredient into a personal-care formulation for an appropriate cosmetic or fragrance purpose.

But when the finished product is marketed specifically as something that repels mosquitoes, the intended use has changed.

The question isn’t simply:

“What essential oils are in this?”

The question becomes:

“What is this product being sold to do, and which regulatory framework applies to that intended use?”

That distinction is especially important when products are promoted on social media, where a casual sentence in a caption can make a much stronger promise than the carefully worded label on the container.

Handmade Does Not Mean Exempt

This may be the biggest misconception of all.

Small makers sometimes operate in a world that feels completely different from the conventional cosmetics industry.

Products may be made on a family property instead of in a giant factory.

Customers may purchase them at a farmers market instead of a national retailer.

The person who formulated the product may also be the person standing behind the table selling it.

Those differences are meaningful culturally.

They don’t automatically erase regulatory responsibilities.

FDA even maintains guidance specifically for small businesses and homemade cosmetics, explaining that while most cosmetics don’t require premarket approval, businesses remain responsible for ensuring that their cosmetics are safe and properly labeled.

Small and handmade are descriptions of a business.

They aren’t regulatory classifications that make every other rule disappear.

Why Doesn’t FDA Stop Every Questionable Product Immediately?

This is another reasonable consumer question.

If cosmetics and therapeutic claims are regulated, why can shoppers still find questionable claims online?

Part of the answer is how the cosmetic marketplace operates.

Most cosmetics don’t receive individual FDA approval before going on sale. A company can therefore place a cosmetic on the market without FDA first sitting down and approving every sentence on its Shopify page.

That should not be confused with FDA endorsing the claims.

FDA can inspect products and facilities, review labeling and promotional claims, issue warning letters, pursue enforcement and exercise other authorities provided by law.

There are real examples of FDA warning companies after websites and promotional materials established intended drug uses for products marketed outside the applicable drug requirements.

The fact that a product is currently available for purchase online does not, by itself, establish that every claim attached to it has been reviewed or approved by a regulator.

That’s an important piece of consumer literacy in the age of direct-to-consumer ecommerce.

Traditional Ingredients and Modern Responsibility Can Coexist

None of this means we believe handmade skincare needs to become sterile, corporate or disconnected from traditional practices.

Quite the opposite.

Naturally Lathered exists because we believe ingredients like beef tallow and goat milk still deserve a place in modern personal care.

But appreciating traditional ingredients doesn’t require ignoring what we’ve learned about cosmetic chemistry, microbiology, preservation, stability, labeling or consumer safety.

We formulate.

We test.

We research.

Sometimes we reformulate.

Sometimes we decide against a marketing claim that would probably sell more product.

And sometimes we use carefully selected modern cosmetic ingredients when they’re appropriate for preservation, stability, texture, performance or safety.

To us, those decisions don’t make a product less authentic.

They are part of taking responsibility for putting our family’s name on something another family will bring into their home.

Why You May Notice More Careful Language From Naturally Lathered

There are plenty of exciting words we could put on labels.

Some would probably make products easier to sell.

But there is a reason we often choose words such as:

moisturizes

conditions

softens

helps protect against moisture

improves the appearance of dry skin

instead of promising to cure, heal or treat medical conditions.

There’s also a reason we don’t assign an SPF value to something merely because it contains an ingredient associated with sunscreen.

And we won’t turn a customer’s wonderful personal experience into a medical claim simply because it would make a great advertisement.

That restraint isn’t an absence of confidence in what we make.

It’s part of respecting the difference between believing in a product and making a claim that requires evidence and regulatory responsibility.

Questions Consumers Can Ask

You don’t need to become a regulatory expert to shop thoughtfully.

When you encounter a handmade personal-care product making an unusually strong promise, consider asking:

• Is this being sold as a cosmetic, or is it claiming to treat or prevent a condition?
• Is an SPF value being presented as an actual tested sun-protection claim?
• Is the company describing an ingredient, or making a claim about what the finished product will do?
• Is a customer testimonial being used as evidence of a medical treatment?
• If something claims to repel insects, does the business explain the regulatory basis under which it is marketed?
• Does the company’s marketing sound dramatically more medical than the actual product label?

None of those questions require consumers to distrust handmade businesses.

They simply encourage the same informed purchasing decisions we should make with products from companies of every size.

Transparency Is More Valuable Than the Biggest Claim

The handmade industry is growing quickly.

We think that’s a good thing.

It gives consumers more choices, supports small businesses and has helped bring renewed attention to traditional ingredients that many people had forgotten.

But growth also brings responsibility.

Our goal at Naturally Lathered Tallow Co. isn’t to make the biggest promise that can possibly fit onto a label.

It’s to continue learning, continue improving our formulations and communicate as accurately as we can about what we’re selling.

We aren’t perfect, and we don’t pretend to know everything. Responsible formulation is an ongoing process.

But one principle is simple enough to keep:

A good formula shouldn’t need an exaggerated claim to make it worth using.

Sources & Further Reading

U.S. Food & Drug Administration (FDA)
Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) — FDA explanation of how intended use affects whether a product is regulated as a cosmetic, drug, or both.https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap

U.S. Food & Drug Administration (FDA)
Cosmetics & U.S. Law — Overview of the legal definition of cosmetics and how certain claims can cause products to meet the definition of drugs.https://www.fda.gov/cosmetics/cosmetics-laws-regulations/cosmetics-us-law

U.S. Food & Drug Administration (FDA)
Small Businesses & Homemade Cosmetics: Fact Sheet — FDA guidance specifically addressing responsibilities applicable to homemade and small cosmetic businesses. https://www.fda.gov/cosmetics/resources-industry-cosmetics/small-businesses-homemade-cosmetics-fact-sheet

U.S. Food & Drug Administration (FDA)
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — Overview of FDA’s expanded cosmetic regulatory authority and current requirements. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra

U.S. Food & Drug Administration (FDA)
OTC Monograph M020: Sunscreen Drug Products for OTC Human Use — Federal requirements governing qualifying OTC sunscreen drug products. https://www.fda.gov/drugs/understanding-over-counter-medicines/questions-and-answers-fdas-regulatory-actions-over-counter-sunscreen

U.S. Food & Drug Administration (FDA)
Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use — FDA guidance concerning sunscreen labeling and effectiveness testing.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-and-effectiveness-testing-sunscreen-drug-products-over-counter-human-use-small-entity

U.S. Food & Drug Administration (FDA)
OTC Monograph M016: Skin Protectant Drug Products for OTC Human Use — Federal OTC framework covering skin-protectant drug products, relevant to certain diaper-rash claims. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/choice-all-natural-inc-dba-om-botanical-685615-10212024

U.S. Environmental Protection Agency (EPA)
Regulation of Skin-Applied Repellents — Explanation of EPA regulation and registration of most skin-applied insect repellents. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-and-effectiveness-testing-sunscreen-drug-products-over-counter-human-use-small-entity

U.S. Environmental Protection Agency (EPA)
Minimum Risk Pesticides Exempted from FIFRA Registration — Explanation of the federal minimum-risk pesticide exemption. https://www.epa.gov/insect-repellents/regulation-skin-applied-repellents

U.S. Environmental Protection Agency (EPA)
Conditions for Minimum Risk Pesticides — EPA’s requirements that must be satisfied for a product to qualify for the federal minimum-risk exemption. https://www.epa.gov/minimum-risk-pesticides/conditions-minimum-risk-pesticides

This article is provided for general consumer education and reflects Naturally Lathered Tallow Co.’s approach to product formulation and marketing. It is not legal or regulatory advice. Businesses should consult current FDA, EPA, and other applicable requirements when determining the classification, labeling, testing, and marketing requirements for their own products.