Background
Before a sunscreen product can be supplied to consumers in Australia, the Therapeutic Goods Administration (TGA)’s approval for its ingredients and their maximum safe concentration is essential. However, the risk assessments for sunscreen ingredients have traditionally been conducted on a case-by-case basis, relying on data provided by sponsors. Different approaches and international models have been employed, while some of these approaches may be conservative or not align with the Australian context. In addition, the variance in exposure calculation methods can result in regulatory inconsistencies and uncertainties for sponsors introducing new ingredients. In this context, a standardized, evidence-based approach is therefore needed to ensure regulatory consistency.