As the cosmetic industry committed to a non-animal policy in alignment with consumer sentiment and regulatory restrictions, the industry is challenged with how to address some human health endpoints that new approach methodologies (NAMs) have not yet reached maturity to support. For ingredients that have been on market and had considerable human exposure for many years, it is a compelling thought to leverage real-world data to inform, address, and assure human health is protected. The session will start with a general overview of real-world evidence (RWE) and the key data sources associated with this type of evidence. This introduction will be followed by an example of how real-world data can be packaged together to address emerging concerns around key ingredients, including caffeine, talc, and synthetic colors. A survey of approaches to assess and integrate observational data, including methodological tools that best facilitate integrating this type of RWE into next-generation risk assessment (NGRA) and traditional risk assessment frameworks, will also be included. The session concludes with a panel discussion exploring how RWE could be leveraged for sunscreen ingredients.