Cosmetics and Sunscreen Safety

ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. We have a reputation for applying sound science and novel approaches tailored to meet the specific needs of our clients, whether a rapid response or a comprehensive analysis is required.

Cosmetics and sunscreen comprise two particular areas of expertise within ToxStrategies consumer product and pharmaceutical services. Both are subject to evolving regulatory climates that presents global challenges in development, testing, and compliance. These challenges must be balanced with consumer interest and perceptions in both ecological hazards and personal health benefit. As many companies move towards use of natural ingredients, such as botanicals, new complexities are introduced in ingredient and product safety assessments. Moreover, evaluations must accommodate heterogenous data from emerging technologies, address endpoints beyond those traditionally evaluated (e.g., endocrine disruption), and be conducted according to rigorous standards — collectively demonstrating the need for strategic, multidisciplinary, systematic approaches in the evaluation of safety for these personal care products. Examples of some areas where our scientists have expertise include the following.

Modernization of Cosmetics Regulation Act (MoCRA)

  • Safety substantiation
  • Adverse-event reporting and record keeping
  • Fragrance allergens
  • Talc-containing cosmetics
  • Good Manufacturing Practices
  • PFAS in cosmetics

Cosmetic Safety Assessments (Ingredient and Finished Product)

  • Template and process development and/or review
  • Screening level or comprehensive literature searches
  • Landscape and data gap assessment
  • Identification of unacceptable and restricted ingredients
  • Hazard evaluation (e.g., endocrine activity, mutagenicity, irritation and sensitization, phototoxicity, photosensitization)
  • Ecological and environmental evaluation
  • Utilization of the Toxicological Threshold of Concern
  • Consideration of high-throughput screening (e.g., ToxCast/Tox21) data
  • ADME, exposure, and risk assessment
  • Conditions of use recommendations
  • Final formula assessment
  • Clinical testing design strategies and evaluation
  • Prop65 evaluation

Non-animal testing methods

  • Design of animal-free testing strategies
  • Placement and monitoring of studies
  • Curation and interpretation of high-throughput screening data • Facilitation of new approach methodologies (NAMs)
  • QSAR and read across


  • Regulatory guidance and strategy for:
    • Nonclinical toxicology programs for sunscreen drug products containing a novel molecular entity (NME) (e.g., via the FDA’s NDA pathway)
    • Nonclinical safety testing to support a positive GRASE (Generally Recognized As Safe and Effective) determination for active ingredients for Over-the-Counter (OTC) sunscreens (e.g.,carcinogenicity, reproductive toxicology, toxicokinetics, endocrine disruption)
  • Pharmacology/Toxicology study design, protocol development, and study management for non-GLP and GLP studies
  • Regulatory document preparation and review
  • Toxicology representation on project teams and regulatory authority meetings
  • Nonclinical safety evaluation of sunscreen final formulation excipients


  • Novel ingredient assessment of botanically-derived ingredients including proteins, waxes, and fibers
  • Characterization of plant extract preparations including essential oils, various extraction methods, etc.
  • Search strategies that employ proprietary and other targeted databases (e.g., BotanyExpert, AHPA, ABC, Natural Standard, EMA)
  • Hazard assessment, data gap identification, and prioritized recommendations
  • History of human use
  • Structural screening of unknown compounds or contaminants
  • Quantitative risk assessment (including TTC)
  • Study design, placement, and oversight

Regulatory/Authoritative Frameworks

  • Scientific Committee on Consumer Safety (SCCS)
  • Food and Drug Administration (FDA) (e.g. Sunscreen Drug Products for Over-the-Counter Human Use; Sunscreen drug products developed under an NDA; GRASE)
  • European Commission
  • United Nation’s Globally Harmonized System (GHS)
  • Classification, Labeling and Packaging of Substances and Mixtures (CLP)
  • Cosmetic Ingredient Review (CIR)