To understand whether your product requires this level of approval, start with what you're trying to claim. Many brands only discover this late in development, leading to delays and extra work. Here are some key signs that your formulation might need to comply with stricter regulations:

Carefully examine your claims.

First, check how your product claims to help improve skin. Claims such as treating acne, soothing eczema, or providing sun protection will categorize your formulation as a therapeutic product. If your wording promises to change the condition of your skin, you've likely entered regulated territory. This means your advertising must adhere to permitted language.

At DAAO Cosmetic OEM, we help you understand which product claims are safe to use, which require in-depth review, and how they affect your development schedule. We see many brands experiencing delays due to not reviewing product claims early enough, so we provide clear guidance to help you through this step. If you need guidance on product claims before starting production, we are always available to support you.

Check the active ingredients in your formulation. Some ingredients have approved medical functions, which automatically subject your product to stricter regulations. Benzoyl peroxide, salicylic acid, hydrocortisone, or zinc oxide are common triggers. If your formulation contains these ingredients at certain concentrations, you may no longer be producing a regular cosmetic.

You must also ensure that the ingredient ratios comply with regulations in your market. Checking this early helps your team choose the right direction before investing in packaging or design.

Consider the markets you plan to enter. Different regions have different standards for determining therapeutic use, which can affect your final decision. A product considered a cosmetic in one country may be subject to stricter regulations in another.

This is especially important if you plan to enter international markets or work with distributors in multiple markets. Depending on the sales location, your team may need different labels, documentation, or testing methods. Planning ahead and considering market rules helps you stay ahead of the curve and avoid costly relabeling later.