So, you have an SPF product and you want to sell it overseas. Simple, just ship the product, right? Wrong. As most formulators are aware, unlike other cosmetics and personal care products, sunscreens create unique challenges for brands selling their products internationally. This article will provide a macro view of key elements that differ between the United States and other regulatory schemes in their treatment of sunscreens.
Classification of Sunscreens
To begin with, sunscreens are classified differently around the world. The United States classifies sunscreens as over-the-counter (OTC) drugs. Canada, which bases much of its system on that of the United States, has a two-part classification: natural health products and drugs, depending on the sunscreen actives. However, in the European Union (EU), Middle East and ASEAN markets, sunscreens are classified as cosmetics. Korea, China and other Asian markets consider sunscreens to be special function cosmetics, similar to OTCs. Australia classifies sunscreens as therapeutic goods unless exempted. As such, the requirements to formulate, test, label and register sunscreens can vary greatly.
Formulating a Sunscreen
Table 1 shows a comparison of approved sunscreen ingredients and levels for the United States, Canada, Australia and the EU. While this is only a sampling of countries, it clearly illustrates the difficulty in creating a single global formula. The United States, having the least number of approved sunscreen actives, may drive global formulations. Table 1 also illustrates why certain ingredients are used more often than others; for example, octisalate is permitted in all four of these markets at 5%.
The process of adding new sunscreen ingredients, depending on the country, can be cumbersome. The large data requirements and associated costs often keep new ingredients from being introduced in markets that consider sunscreens as drugs.
Testing a Sunscreen
The U.S. Food and Drug Administration (FDA) stipulates the testing required to determine the efficacy of a sunscreen. In most other regions, with the exception of Australia and New Zealand, ISO sunscreen test methods are used. While all have similar elements, SPF test methods differ slightly, for example, in their determination of SPF or static SPF, UVA or broad-spectrum coverage, waterproof or water-resistant properties, photostability, critical wavelength and stability. Table 2 and Table 3 summarize the basic requirements and differences between test methods for static SPF and broad-spectrum testing. Table 4 provides in vivo requirements.
Labeling a Sunscreen
The required labeling for sunscreens makes it virtually impossible to sell a single global product. The United States and Canada require Drug Facts boxes, which identify the active ingredients, their functions (sunscreen) and the percentage of the actives in the formula as well as directions, warnings and other FDA requirements as established for OTC drug products in the Sunscreen Monograph.
Since the EU does not consider sunscreens as drugs, only the labeling requirements established in EC No. 1223/2009 are required. ASEAN markets and the Middle East, as well as some South American countries, generally follow the same requirements as the EU.
Further, with the exception of the United States, in most markets that classify sunscreens as drugs—e.g., special function cosmetics, therapeutic goods or medicinal products—the registration number must be printed on the package. In some cases, over-labeling can be used to satisfy this requirement so long as the label is permanently affixed. Table 5 summarizes basic differences in labeling requirements.
Registering a Sunscreen
Finally, requirements to register sunscreens are different in most markets, often due to differences in classifications. Example requirements include: annual vs. one-time registration; free vs. paid; and registration vs. notification, in addition to data requirements. Markets requiring registration will request a combination of safety testing, efficacy (SPF) testing, certificates of analysis, stability testing, formulas, specialty testing of actives, labeling and product samples.
Further, while sunscreens are considered cosmetics in the EU, safety assessments and entry into the Cosmetic Products Notification Portal are required, which depending on the company, may incur associated costs.
Clearly, developing sunscreen products in a global market poses challenges, but having all the facts in place and understanding the various requirements sheds some light on the process to make it much easier.
Acknowledgements: Tables were created with support from Suncare Labs, Winston-Salem, NC.