Safety considerations for sunscreens in the USA

Sunscreens: Regulations and Commercial Development

Volumn , Issue , 2005, Pages 55-69

  Schwen, Richard J ^a  

^a PAREXEL INTERNATIONAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85056942709     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (18)

1. Code of Federal Regulations Title 21, Section 352.10. Sunscreen active ingredients. Revised as of April 1, 2003. Final Rule May 21, 1999.
2. Approved Drug Products with Therapeutic Equivalence Evaluations, US Department of Health and Human Services, Food and Drug Administration, 1996.
3. Robinson MK. Population differences in acute skin irritation responses. Race, sex, age, sensitive skin and repeat subject comparisons. Contact Dermatitis 2002; 46(2): 86-93.
4. Shaath NA, ed. Sunscreens: Regulations and Commercial Development. 3rd ed. New York: Marcel Dekker, 2005.
5. Steinberg DC. Regulations of sunscreens worldwide. In: Shaath NA, ed. Sunscreens: Regulations and Commercial Development. 3rd ed. New York: Marcel Dekker, 2005: 173-198.
6. OECD Guidelines for the Testing of Chemicals. Vol. 1. Paris: Organization for Economic Co-operation and Development, 1993.
7. Haschek WM, Rousseaux CG. Handbook of Toxicologic Pathology. New York: Academic Press, 1991.
8. Niesink RJM, Vries J, Hollinger MA. Toxicology Principles and Applications. New York: CRC Press, 1996.
9. Marrot L, Belaidi JP, Chaubo C, Meunier JR, Perez P, Causse C. An in vitro strategy to evaluate the phototoxicity of solar UV at the molecular and cellular level: application to photoprotection assessment. Eur J Dermatol 1998; 8: 403-412.
10. Nohynek GJ, Schaefer H. Benefit and risk of organic ultraviolet filters. Regul Toxicol Pharmacol 2001; 33: 285-299.
11. Opinion concerning basic criteria for the in vitro assessment of percutaneous absorption of cosmetic ingredients. EU Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers. June 23, 1999.
12. Kasting GB, Filloon TG, Francis WR, Meredith MP. Improving the sensitivity of in vitro skin penetration experiments. Pharm Res 1994; 11(12): 1747-1754.
13. Franz TJ. Percutaneous absorption and the relevance of in vitro data. J Invest Dermatol 1975; 64(3): 190-195.
14. Schwen RJ. Drug development, quality of data, and meetings with the FDA. Presented at the Australian Biotechnology Association Meeting, Brisbane, Australia, Nov 2002.
15. Kimber I, Dearman RJ, Basketter DA, Ryan CA, Gerberick GF. The local lymph node assay: past, present and future. Contact Dermatitis 2002; 47(6): 315-328.
16. Buehler EV, Newmann EA, Parker RD. Use of the occlusive patch to evaluate the photosensitive properties of chemicals in guinea pigs. Food Chem Toxicol 1985; 23(7): 689-694.
17. Gettings SD, Lordo RA, Demetrulias J, Feder PI, Hintze KL. Comparison of low-volume, Draize and in vitro eye irritation test data. I. Hydroalcoholic formulations. Food Chem Toxicol 1996; 34(8): 737-749.
18. New Horizons and Future Challenges. Sixth International Conference on Harmonisation, Osaka, Japan, Nov 15, 2003.