Do I Need FDA Approval to Start a Skincare Line?


Skincare products are used every day by millions of people in the United States. Skincare companies understand how vital these products are to their customers and their brand, which is why they are continually looking to produce high-quality products. One of the ways companies achieve this is by hiring private label companies to mass-produce their skincare products. However, there is concern about relegating this responsibility to a third party. After all, there are regulations in place that may significantly impact your overall business if you fail to comply. You may wonder if you need approval from the FDA (Food and Drug Administration) to start your skincare line in the United States. Anthem United States of Beauty explains.

What is the FDA’s Authority Over Skincare Product Manufacturing?

Typically, the law does not require cosmetics – including skincare products – to be FDA-approved. However, cosmetics are FDA-regulated. The FDA has to approve the inclusion of certain types of color additives that may impact the end-user. Under federal law, cosmetics are articles intended to be applied to the human body for “cleansing, beautifying, promoting attractiveness, or altering the appearance.” This represents the definition of cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C), one of the most important entities when it comes to cosmetics marketed within the United States.

Typically, the FDA’s legal authority rests within the parameters of drugs, biologics, and medical device regulation. The FDA doesn’t have to pre-approve a cosmetic to be launched to market. However, the FDA can intervene in situations where a cosmetic brand is non-compliant with laws regulating its contents or ingredients. In other words, the FDA can take action against those who violate FD&C regulations, guidelines, and laws.

When it comes to skincare product manufacturing – or any other cosmetic – the FDA has been consistent in advising any and every manufacture to exercise the utmost caution and run whatever tests are necessary to ensure their products are safe. The FDA will not require a manufacturer to turn over their client’s formulations and run independent testing to determine whether their products are safe. However, if a skincare product contains ingredients that may be detrimental to a person’s health, they can enforce the law and go against the product manufacturer.

How Can a Private Label Manufacturer Ensure FDA Compliance?

Private label manufacturers provide a suite of different ingredients to formulate a particular product such as facial masks, wipes, lotions, and other cosmetics. During the formulation process, these companies have to remain compliant with any state and federal regulation. This means your skincare product manufacturer can take care of making sure their ingredients – and by default, your final product – fall within FDA-mandated guidelines.

Many private label companies have in-house chemists who work with different ingredient combinations to create specific formulations. The advantage of this is that it allows private label manufacturers to control their ingredients and make sure they fall within the established legal parameters.

However, what does this mean for customers retaining the services of a private label company? You may understand little or nothing about the latest FDA regulations pertaining to cosmetics – particularly skincare products. Entrusting your cosmetic to a private label company can help you develop a consistent product within the laws and regulations set forth by the FDA. Additionally, you can make sure your customers are using a perfectly safe product, thus, increasing your transparency while building customer loyalty.

How Does Private Label Skincare Manufacturing Work?

Private label manufacturing is a streamlined process consisting of steps that allow a customer to create their own cosmetic. Unlike contract manufacturing, where you’d be responsible for most of the work, in private label manufacturing, you entrust the creation of your product to experienced professionals. The concept of private label manufacturing exists to provide customers with a turn-key process that allows them to control their product’s creation process and packaging. Creating a skincare product through a private skincare label typically requires the following steps:

Initial consultation

During your initial consultation, you will sit with a professional who can walk you through the entire process and what it takes to create your skincare product. This is also the first opportunity to provide your private label manufacturer with input about the skincare product you wish to create.


Once you have provided your skincare manufacturer with ideas about the product you wish to create, your product will go through the formulation phase. During this stage, dedicated chemists will add the ingredients necessary to create your product, following FDA regulation.


Once the formulation phase ends, your private label manufacturer will enter into full production. Following formulation indications, your manufacturer will produce your skincare product according to the amounts of product you require.


One of the most critical aspects of skincare product manufacturing is packaging. Packaging is essential for two main reasons. First, it is the first thing a customer will look at when deciding their purchase. Presentation is key when packaging your product. Additionally, your product’s packaging has to hold its content safely. Thus, professionally-designed packaging can help you boost your presence while preserving your skincare product’s integrity.


The last thing you want is to invest in your product’s production and have a delayed turn-in. This is something you can avoid with private label skincare manufacturing services. Typically, your manufacturer will formulate, create, package, and deliver your product as soon as production is done. This way, you can have peace of mind knowing you can rely on a fast turn-in.

Skincare Product Manufacturer Providing Private Label Services in the U.S.

Skincare companies looking to enter into the beauty market or established businesses looking to expand their product lines should consider Anthem United States of Beauty. We are a dedicated B2B company providing professional private label services to companies in the U.S. Thanks to our experience, skill, and knowledge, we can provide our customers with the services they need. To learn more about our turn-key process, call our offices today and schedule a visit with one of our team’s professional. Our phone number is (973) 779-1982.