On July 31, 2025, in order to further regulate and guide the research and evaluation of sunscreen cosmetics, the Cosmetic Supervision Department under China's National Medical Products Administration (NMPA) organized the National Institutes for Food and Drug Control (NIFDC) to draft two technical guidelines: the Technical Guidelines for the Research of Sunscreen Cosmetics (Trial) (Draft for Comments) and the Technical Guidelines for the Research on Quality Control Standards of Sunscreen Cosmetics (Trial) (Draft for Comments), along with their respective drafting instructions. These documents have been released to the public for consultation.

The following content provides an interpretation of sunscreen cosmetics from the perspectives of definition and classification, mechanism of action research, and quality controllability research, for reference.

Definition and Classification

Sunscreen agents incorporated into sunscreen cosmetics are capable of absorbing, reflecting, or scattering ultraviolet (UV) radiation, thereby protecting the skin and lips from damage caused by specific UV rays. As sunscreen cosmetics are applied directly to the skin and may be exposed to sunlight for extended periods, the safety and stability of their ingredients are directly related to consumer health. Therefore, it is necessary to conduct research on aspects such as the mechanism of action, quality controllability, safety, product efficacy, labeling, and label claims of sunscreen cosmetics. This ensures that sunscreen cosmetics can effectively defend against UV radiation while minimizing the risk of skin irritation, allergic reactions, or other adverse effects.

In accordance with the Cosmetics Supervision and Administration Regulations, sunscreen cosmetics fall under the category of special cosmetics and are subject to registration management. According to the Cosmetic Classification Rules and Classification Catalogue, sunscreen cosmetics refer to cosmetics intended to protect the skin and lips from damage caused by specific ultraviolet (UV) radiation. In the classification code, the efficacy claim must include “sun protection,” and the site of action must not correspond to hair. For infants and children, the site of sun protection is limited to the skin.

The research content of sunscreen cosmetics primarily includes studies on the mechanism of action, quality controllability, safety, product efficacy, labeling, and label claims.

Mechanism of Action Research

When conducting research on sunscreen cosmetics, it is essential to determine their mechanism of action. Excessive ultraviolet (UV) radiation can cause skin damage, and different wavelengths of UV radiation may produce distinct biological effects. UVA radiation, with wavelengths ranging from 320 to 400 nm, is also known as the "tanning" range. It has strong penetrating power, reaching the dermis, accelerating melanin production, and leading to skin darkening. Prolonged exposure to UVA can damage elastic fibers and collagen in the skin, resulting in photoaging.

UVB radiation, with wavelengths between 280 and 320 nm, is referred to as the "burning" range. It is the primary cause of sunburn, leading to skin redness and pain; in severe cases, it can cause blistering and peeling. UVC radiation, with wavelengths between 200 and 280 nm, is almost entirely absorbed by the Earth's ozone layer and generally does not pose a threat to human skin.

The efficacy ingredients in sunscreen cosmetics-referred to as sunscreen agents-include physical and chemical sunscreens. Physical sunscreen agents primarily function by reflecting or scattering ultraviolet (UV) radiation, while chemical sunscreen agents mainly work by absorbing specific wavelengths of UV radiation. During formulation research of sunscreen cosmetics, the mechanisms of action of different sunscreen agents should be comprehensively considered. Appropriate sunscreen agents should be selected to achieve effective sun protection performance.

Quality Controllability Research

The quality controllability research of sunscreen cosmetics primarily includes the evaluation of raw materials and their safety information, formulation and design, as well as manufacturing processes and quality control measures.

1. Raw Materials and Safety Information

The selection and use of raw materials shall comply with the requirements of relevant regulations and technical standards. Taking into account the product dosage form, the primary intended function of each ingredient should be clearly defined based on its actual role in the product. The chosen materials must be compatible with their physicochemical properties, product characteristics, and formulation processes. When selecting nano-sized materials, factors such as the product dosage form and target consumer groups should be considered, and the safety of such materials under actual use conditions must be thoroughly evaluated.

2. Formulation Design

(1) General Requirements for Formulation Design

The formulation of sunscreen products typically includes sunscreen agents, emulsifiers, stabilizers, and other components. Appropriate sunscreen agents and base materials should be selected based on factors such as the product dosage form, characteristics of raw materials, desired sun protection efficacy, method of application, and target consumer groups.

Physical sunscreen agents, such as zinc oxide and titanium dioxide, are generally more stable and less prone to oxidation or degradation. In contrast, chemical sunscreen agents tend to have lower stability and require the addition of suitable stabilizers during formulation design. When multiple sunscreen agents are used in combination, compatibility and potential synergistic effects should be evaluated in accordance with the formulation characteristics.

(2) Imported Sunscreen Cosmetics Specifically Designed for the Chinese Market

For imported sunscreen cosmetics specifically designed for the Chinese market (excluding those manufactured overseas under domestic commission), formulation design should be based on the skin types and consumer needs of Chinese consumers. Research and development efforts should include analyses such as the Fitzpatrick skin type classification of Chinese consumers, their specific ultraviolet (UV) response characteristics and associated health risks, the intensity and distribution patterns of UV radiation in China, and market research based on domestic health and consumer demands.

These studies provide a scientific basis for product development and formulation design, and demonstrate the necessity and relevance of tailoring formulations specifically for the Chinese market.

(3) Formulation Design for Children's Products

The formulation design principles for children's products should comply with the Provisions on the Supervision and Administration of Children’s Cosmetics and the corresponding technical guidelines.

3. Manufacturing Process and Quality Control

(1) Manufacturing Process

The manufacturing process should be designed based on the characteristics of the product dosage form, with full consideration of the physicochemical properties of raw materials to ensure uniform mixing. The registrant should take into account the specific features of the product and the actual production process, with particular attention to the procedures and parameters involved in the addition of sunscreen agents-such as the accuracy of sunscreen agent dosing. Comprehensive studies should be conducted on the effects of factors such as temperature and processing time on the stability of sunscreen agents during manufacturing.

(2) Quality Control

Quality control specifications should be scientifically and reasonably established based on the product formulation, manufacturing process, usage method, and stability study data. Necessary quality control measures should be implemented to ensure product quality and safety. These measures must be practical, scientifically justified, and appropriate to the actual production conditions. The quality control standards for sunscreen cosmetics primarily focus on aspects such as product stability, quality control specifications, and quality management measures.

(a) Stability Studies

Stability studies are a fundamental component of product quality and safety evaluation, providing a scientific basis for determining the product’s shelf life and setting quality control specifications.

Stability studies should focus on parameters that are prone to change during storage and may impact product quality, safety, or efficacy. These parameters include, but are not limited to, product appearance (e.g., color), microbiological indicators, and the content of sunscreen agents (active ingredients). The studies should monitor how these parameters change over time under the influence of factors such as temperature, humidity, and light. In addition, the potential impact of packaging materials on product quality should be fully considered.

(b) Study on Quality Control Items and Specifications

Based on stability studies, and taking into account the product formulation, manufacturing process, and stability data, scientific, reasonable, and feasible quality control items and specifications should be established under the product’s applicable standards for "Microbiological and Physicochemical Indicators and Their Quality Control Measures." These indicators should effectively reflect product safety and quality controllability.

For sunscreen cosmetics, quality control items and specifications include harmful substances, microbiological indicators, and active ingredient (sunscreen agent) indicators. The specifications for sunscreen agents should be determined in accordance with the product formulation, in order to ensure batch-to-batch consistency and stability, and to maintain overall product quality under control.

(c) Study on Quality Management Measures

To ensure the safety and quality of sunscreen cosmetics, each quality control item and its corresponding specification should be supported by scientific and reasonable quality management measures. At least one quality management measure should be implemented for each control item, and a brief description should be provided to elaborate on the specific implementation plan. The "quality management measures" and the "brief description" for the same item and specification should correspond to each other, align with actual manufacturing conditions, and be feasible in practice, in order to ensure that the final product complies with the Technical Guidelines and applicable product standards.

Quality management measures may include inspection-based or non-inspection-based approaches. Inspection-based approaches include, but are not limited to, batch-by-batch testing and type testing, and should specify reasonable testing frequencies, among other requirements.

Non-inspection-based approaches include, but are not limited to, control of raw material specifications and monitoring of manufacturing process parameters.

Safety Assessment

After finalizing the formulation and manufacturing process of a sunscreen cosmetic product and completing its production, safety testing should be conducted. Safety evaluation primarily includes microbiological testing, physicochemical analysis, toxicological studies, and human safety tests. The product safety assessment should be based on all ingredients in the formulation, as well as any known hazardous substances. It must also take into account relevant factors such as the product’s intended use, site of application, and exposure level to ensure an accurate and comprehensive risk evaluation. The safety assessment report must be complete, standardized, and compliant with applicable regulatory requirements.

The types of evidence used in product safety assessment shall comply with the requirements outlined in relevant documents such as the Guidelines for Use of Cosmetic Ingredient Data. The assessment may also refer to technical documents including the Guidelines for the Submission of Cosmetic Safety Assessment Data, Information on Ingredients Used in Marketed Products, Technical Guidelines for the Application of the Threshold of Toxicological Concern (TTC) Approach, and Technical Guidelines for the Application of the Read-Across Method. These documents provide scientific and regulatory frameworks to support comprehensive and reliable safety evaluations.

For aerosol sunscreen products, particular attention should be paid to the safety assessment of propellants. If nano ingredients are used, their safety evaluation must also be addressed accordingly.

(1) Safety Assessment of Aerosol Sunscreen Products

Due to the high volatility of propellants, only trace amounts typically remain on the skin after use. Therefore, the actual exposure of the human body to the non-propellant ingredients should be calculated based on their concentrations in the formulation excluding the propellant (i.e., normalized to 100% without the propellant). Propellants and non-propellant ingredients should be assessed separately. The concentration of each non-propellant ingredient for safety evaluation should be based on its proportion in the reformulated composition excluding the propellant. The propellant may be evaluated independently or based on its use concentration in the overall formulation.

In addition, for aerosol sunscreen products with potential inhalation exposure, the inhalation toxicity of the propellant must also be evaluated as part of the safety assessment.

(2) Safety Assessment of Nano Ingredients

When nano ingredients are used in sunscreen cosmetic products, the quality specifications and safety information provided by the raw material manufacturer must be clearly defined. Such specifications and safety data should include, but are not limited to, information on purity, crystal structure, primary particle size distribution, and surface coating substances.

The safety evaluation should be based on these quality specifications and safety data, and must comprehensively assess the nano ingredient at the level used in the formulation. Additionally, the applicability of the toxicological testing methods used in the assessment to nano materials should be clearly justified. Due to their small particle size, nano ingredients carry a higher risk of inhalation exposure. Therefore, the use of nano materials in products with potential inhalation exposure is not recommended.

In accordance with the Provisions on the Supervision and Administration of Children’s Cosmetics and the associated technical guidelines, the use of raw materials manufactured using new technologies such as nanotechnology is not permitted in children's sunscreen products. If no suitable alternative is available and such materials must be used, the justification for their use must be clearly explained, and a dedicated safety assessment for use in children's cosmetics must be conducted.

(3) Safety Assessment of Children's Cosmetic Products

When conducting the safety assessment of children's cosmetics, the principles underlying the formulation design must be clearly stated. The formulation should adhere to the principles of safety first, efficacy as necessary, and minimalist composition. Each ingredient should be evaluated for its scientific rationale and necessity based on its safety profile, stability, function, and compatibility, taking into account the physiological characteristics of children and potential usage scenarios.

Particular attention should be paid to the assessment of ingredients such as fragrances, colorants, preservatives, UV filters, and surfactants. The evaluation should consider the specific risks these substances may pose to children and their appropriateness in pediatric formulations.

The safety assessment should comply with the requirements outlined in the Technical Guidelines for Cosmetic Safety Assessment and associated technical documents. The types and sources of safety evidence should meet the standards specified in relevant documents such as the Guidelines for Use of Cosmetic Ingredient Data.

Efficacy Evaluation of the Product

The registrant shall conduct efficacy studies of sunscreen cosmetic products in accordance with the Cosmetics Supervision and Administration Regulations, the Cosmetic Classification Rules and Classification Catalogue, and relevant technical guidelines, based on the product's research and development background and its actual characteristics.

The efficacy evaluation of sunscreen products primarily includes efficacy testing for sun protection performance (e.g., SPF, UVA protection), as well as other claimed efficacy studies, where applicable. All efficacy claims must be supported by scientific evidence derived from standardized testing methods, and the test design should be consistent with the product's intended use and target population.

Labeling and Claim-Related Studies

The usage instructions for sunscreen cosmetic products should be designed to ensure that consumers apply the product correctly in order to achieve the intended sun protection effect. For example, the instructions should clearly specify the recommended amount of application, timing of application prior to sun exposure, and reapplication frequency. All information provided should be scientifically sound and reasonable.

For aerosol sunscreen products that use flammable gases as propellants, the labeling must comply with relevant Chinese regulations and technical standards. It should include warnings such as "Caution: Flammable. Keep away from fire and explosion hazards", either in text or pictogram form. In addition, the label should contain clear precautionary statements such as:

• "Do not spray directly onto the face"
• "Spray onto hands before applying to the face"
• "Avoid inhalation"

Sunscreen cosmetic products must indicate sun protection-related claims. The claimed content shall be consistent with the results of sun protection efficacy tests. The labeled SPF value, PA rating, and post-immersion SPF value shall correspond to the results of human efficacy evaluation test reports. The minimum labeled SPF value shall be 2, and the maximum labeled value shall be 50+. The PA rating shall correspond to the measured PFA value.

For products with non-separable packaging (different formulations in each part and only one product name), if each part may be used independently, sun protection efficacy studies shall be conducted separately for each part. If the sun protection efficacy test results of each part are the same and support the same labeled value, a unified label may be used; otherwise, the sun protection efficacy of each part shall be labeled separately.

Based on the product formulation and the results of efficacy evaluation tests, sunscreen cosmetic products may claim the mechanism of action of the sunscreen agents or related functional benefits, such as “protects against/isolation from UVA and UVB,” “prevents tanning, sunburn, and redness,” “protects against UVA to prevent tanning,” or “protects against UVB to prevent redness,” and similar claims.

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

Cosmetic services in China:

• China Cosmetic Registration and Filing;
• China New Cosmetic Ingredient Registration and Filing;
• China Cosmetic Ingredient Quality and Safety Information Code Application (NMPA Code);
• China Cosmetics Efficacy Evaluation;
• In-vitro Safety and Efficacy Evaluation;
• China Cosmetic Safety Assessment Report;
• China Toothpaste Filing;
• China Disinfectant Notification; 
• China Cosmetic Formula/Label/Claim Review; and
• Customs Clearance

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.

Further Information

https://www.nifdc.org.cn//nifdc/bshff/hzhpjssp/hzpsptzgg/202507310840431663213.html