26Understanding the U.S. FDA requirements for skin care products is the primary hurdle for any related product to enter the U.S. market. Within the U.S. regulatory system, “skin care products” do not constitute an independent legal category; their regulatory pathway depends entirely on the product’s intended use — whether it is defined as a “cosmetic”, a “drug”, or an “over-the-counter (OTC) cosmetic-drug combination product”. Enacted in 2022, the Modernization of Cosmetics Regulation Act (MoCRA) has brought about fundamental changes, significantly enhancing the proactivity and stringency of regulation. Therefore, accurately grasping the FDA’s requirements for skin care products is crucial for enterprises to achieve compliance and market success.
1.Regulatory Watershed
The FDA requirements for skin care products have entered a new era since 2022. The passage of the Modernization of Cosmetics Regulation Act (MoCRA) represents the most significant reform of the U.S. cosmetics regulatory system since 1938, marking a shift from an industry-self-regulation-dominated model to one of proactive FDA oversight.
This Act has granted the FDA a series of new key authorities. Among these, the most deterrent power is the mandatory recall authority — when the FDA determines that a cosmetic product poses a serious health risk, it may compel the enterprise to recall the product. Meanwhile, all facilities engaged in the manufacture, processing, packaging, or storage of cosmetics within the United States must register with the FDA and renew their registration every two years.
In addition, the Responsible Person of a product must submit a detailed list of all products sold in the U.S.—including ingredient information—to the FDA, with annual updates required. Enterprises must also establish and maintain adequate records of Safety Substantiation to prove product safety, which constitutes the core embodiment of clarifying the responsible entity in the FDA requirements for skin care products.
2.How Products Are Classified
Under the framework of the U.S. FDA, there is no legal category of “skin care products”. The regulatory status of a product is determined entirely by its “intended use“, which is primarily judged by the claims made on product labels, websites, and advertisements.
The FDA requirements for skin care products vary drastically depending on their classification:
- Cosmetics: Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these refer to articles intended solely for cleansing, beautifying, enhancing attractiveness, or altering appearance (e.g., regular facial creams and cleansers that only claim “moisturizing” or “cleansing” benefits).
- Drugs: These refer to articles intended for diagnosing, treating, mitigating, or preventing diseases, or affecting the structure or function of the body (e.g., products that claim to “treat acne” or “provide sun protection”).
- Cosmetic-Drug Combinations (Over-the-Counter): Products that serve both of the above purposes and are subject to the strictest regulatory oversight (e.g., anti-wrinkle creams that both beautify appearance and claim to affect skin structure).
Classification Judgment Comparison Table
| Judgment Dimension | Classified as a “Cosmetic” | Classified as a “Drug” | Classified as an “Over-the-Counter (OTC) Cosmetic-Drug Combination Product” |
| Legal Basis | Federal Food, Drug, and Cosmetic Act | The Definition of “Drug” under the FD&C Act | Meet the requirements of both simultaneously |
| Key Judgment Criteria | Claims Involve Only Cleansing and Cosmetic Purposes | Claims involve the treatment, prevention of diseases, or the modification of bodily functions | Make both cosmetic and efficacy/therapeutic claims |
| Pre-market Approval | Generally no FDA approval is required (except for color additives). | Generally required (e.g., when complying with OTC drug monographs or submitting new drug applications) | It must meet the dual requirements of both cosmetics and drugs simultaneously. |
| Regulatory Core | Enterprises bear sole responsibility for product safety, and MoCRA has strengthened post-market supervision tools. | Strict compliance with drug safety, efficacy, and labeling regulations is required. | It has the most complex regulatory chain and the highest requirements |
| For example | Ordinary perfumes, moisturizers without special claims, and color cosmetics | Sunscreen, anti-dandruff shampoo, and fluoride-containing toothpaste | Anti-acne facial cleanser, anti-wrinkle cream, and day cream with sun protection factor |
An important regulatory red line is as follows: in the United States, all sunscreen products are explicitly classified as over-the-counter (OTC) drugs rather than cosmetics, and enterprises must comply with pharmaceutical regulations. This is a distinctive feature in global regulation and also a key aspect requiring special vigilance in the FDA requirements for skin care products.
3.Core Compliance Obligations
Regardless of the classification a product falls into, enterprises are required to fulfill a series of core compliance obligations. Under the framework of MoCRA, these obligations for cosmetics have been significantly strengthened and clarified.
Safety Certification and Adverse Event Reporting
Enterprises must ensure that they have sufficient evidence to prove product safety, and report any serious adverse events (such as those resulting in death, hospitalization, disfigurement, etc.) to the FDA within 15 working days of becoming aware of them. This reflects that the FDA requirements for skin care products are shifting from a “reactive post-event” approach to a “full-cycle monitoring” approach. Enterprises are required to retain all records of adverse events for a minimum of 3–6 years.
Mandatory Requirements for Labeling and Packaging
Product labels must be clear, truthful and include the following elements: product identity statement, net content, ingredient list in descending order of concentration, and the name and address of the responsible party. The new MoCRA regulations require the provision of a U.S. address, telephone number, or electronic contact information to facilitate the receipt of adverse event reports. It is particularly important that products must not bear the claim of “FDA-approved”, as the FDA does not conduct pre-market approval for cosmetics.
For specific products, such as certain liquid products, tamper-evident packaging must be used to ensure that signs of tampering are clearly visible, thereby protecting consumer safety.
Good Manufacturing Practices(GMP)
MoCRA mandates that the FDA formulate Good Manufacturing Practices (GMP) regulations for cosmetics. Currently, the FDA has a draft GMP guideline dating back to 2013 for reference, which draws on the international standard ISO 22716. The mandatory GMP regulations will ensure product quality and safety at the production source, representing the future direction for the systematization and refinement of the FDA requirements for skin care products.
4.Facility Registration and Product Listing
MoCRA has established mandatory facility registration and product listing procedures for the cosmetics industry for the first time, which serve as the cornerstone of building a product traceability system.
Who Needs to Register: All facilities engaged in the manufacture or processing of cosmetics in the United States must register. However, certain small businesses (with average annual sales of less than $1 million over the past three years) may be eligible for exemption, except for those producing specific high-risk products (e.g., injectable cosmetics, eye-contact cosmetics, and leave-on cosmetics).
How to Proceed: Enterprises are required to submit applications via the FDA’s Cosmetics Direct online portal or the Electronic Submission Gateway (ESG). Registrations must be renewed every two years following initial submission, and any changes to registered information must be updated within 60 days.
Deadlines and Statistics: As of January 6, 2026, over 14,000 facilities and nearly 993,000 products have completed listing. Notably, China is the overseas origin with the largest number of registered manufacturing facilities.
5.Frequently Asked Questions (FAQ)
Will the FDA approve skincare products before they are marketed?
For products legally defined as “cosmetics”, the FDA generally does not require pre-market approval (except for color additives), and enterprises bear full responsibility for product safety. For “drugs” (e.g., sunscreens, anti-acne products), pre-market approval or compliance with OTC drug monographs is usually mandatory. This constitutes the core classification-based distinction in the FDA requirements for skin care products.
Is the claim of “natural” or “organic” subject to special regulation by the FDA?
The FDA does not have an official definition for the term “natural”. As for “organic”, its agricultural sources may be subject to the standards of the U.S. Department of Agriculture (USDA), but the FDA does not certify it when used as a cosmetic claim. Enterprises must ensure that such claims are not misleading and are supported by evidence.
How can consumers quickly determine whether a product complies with FDA requirements?
Consumers can check whether the label contains all mandatory information (such as ingredients and responsible party); be alert to any suspicious or exaggerated claims (e.g., “curing” a certain skin disease); and check the FDA official website for any warnings or recall information about the product.
What does it mean if a product is labeled as “FDA-registered”?
“FDA-registered” only indicates that the manufacturing facility has been filed with the FDA or the product has been listed, and by no means implies that the FDA has approved or endorsed the safety and effectiveness of the product. Such labeling may be misleading to consumers.
Is there an exemption for small businesses under the new bill?
Yes, MoCRA grants exemptions to eligible small businesses (those with average annual sales of less than $1 million over the past three years and that do not deal in specific eye products, injectables, etc.) with respect to facility registration and product listing. However, such businesses are still required to comply with the requirements for safety certification, adverse event reporting and GMP.
Summary and Outlook
The U.S. FDA has established a dynamic and rigorous regulatory framework based on precise classification by “intended use”. For enterprises, the compliance of product claims has become an insurmountable red line and primary consideration throughout product development and marketing.
Currently, the FDA requirements for skin care products are increasingly aligning with pharmaceutical regulatory standards, with an emphasis on safety evidence and traceability throughout the entire product lifecycle. Enterprises must deeply integrate compliance into every stage of the product lifecycle—from formula design and claim formulation to production, packaging, and post-market surveillance.
Looking ahead, as the detailed provisions of MoCRA (such as specific GMP standards and labeling requirements for fragrance allergens) are further refined, and with state-level legislative initiatives targeting specific ingredients (e.g., PFAS), the regulatory landscape will grow increasingly stringent and complex. Only by proactively building a product safety culture and compliance system that exceed baseline requirements can brands win consumer trust and achieve sustainable success in the world’s largest consumer market.
If you are seeking a reliable skincare OEM manufacturer to help your products meet stringent FDA compliance requirements and succeed in the market, please feel free to contact us. Our professional team possesses in-depth expertise in U.S. regulations, and we can provide end-to-end support covering formula R&D, safety testing, compliance documentation preparation, and full-cycle production that complies with Good Manufacturing Practices (GMP). This allows you to focus more on brand building and market expansion.
