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…/…

Testing a Sunscreen

The U.S. Food and Drug Administration (FDA) stipulates the testing required to determine the efficacy of a sunscreen…