In order for a sunscreen to be marketed in the country, it must meet some basic requirements, which aim to establish a quality product and guarantee consumer safety. These requirements include

• The formulation: Present the physical and chemical agents that are part of the composition, which ingredients are present in the formula and their purpose, if there are any limitations or prohibitions.
• Efficacy: Evaluation of UVA and UVB protection in relation to different levels of sun protection factor (SPF).
• Safety: Skin sensitization tests in the general population, and in specific populations such as children and pregnant women.
• Labeling: The information must be legible and presented in a clear and objective manner.
• Stability: Shelf life of the product and expiration date.
• GMP: The facilities and manufacturing processes must comply with the Good Operating Practices required by ANVISA.

As previously mentioned, ANVISA seeks to ensure that products marketed in Brazil meet certain quality and safety standards, and for this reason the registration process requires complete and detailed documentation. The company responsible for manufacturing the product, in this case the sunscreen, must prepare a technical dossier containing all the relevant information about the studies and tests carried out, as well as other specific documents that ANVISA may request. This documentation will be submitted for analysis to check that all the technical and legal requirements have been met. This stage can take time depending on the complexity of the product and the amount of information submitted. Depending on the case, ANVISA may carry out an inspection at the manufacturer's premises to check that Good Manufacturing Practices are being properly implemented. After these steps, a decision is issued on the registration of the product, which may be favorable or unfavorable.

The legislation that regulates sunscreens is constantly evolving, as it keeps pace with advances in research and new scientific evidence, which provides information on the mechanisms of action of sunscreens and the effectiveness of different formulations, thus meeting the new demands of consumers. These updates and changes are fundamental to guaranteeing the safety, efficacy and transparency of products, as well as promoting innovation by encouraging the development of new products with safer ingredients and more advanced technologies for consumers.

The process of registering a sunscreen can be very extensive, detailed and bureaucratic, and to reduce the risk of errors it is important to rely on a strategic partner like Stone Okamont, which has a team of trained professionals with in-depth technical and specific knowledge. This way, we can streamline your process and avoid unnecessary rework costs. Talk to us!