PERRY ROMANOWSKI 
Element 44 Inc, Chicago, USA

Abstract

To understand the problem of sunscreen actives it’s helpful to know how these formulas are regulated. Unlike most personal care products, in the US sunscreens are regulated as Over-the-counter (OTC) Drugs.

MAIN SUNSCREEN FORMULATION CHALLENGES

There are a number of sunscreen challenges but the two things that make it most difficult are a lack of acceptable sunscreen actives and concern about sunscreen impact on the environment. Let’s look at each of those.

To understand the problem of sunscreen actives it’s helpful to know how these formulas are regulated. Unlike most personal care products, in the US sunscreens are regulated as Over-the-counter (OTC) Drugs. That’s because they are designed to treat or prevent disease, namely sunburns. The OTC status means that the government has created a monograph which lists the only legal types and levels of active ingredients allowed for use in sunscreens. If you want to make and sell a sunscreen in the US, you have to follow the monograph. Things are slightly different in the EU and elsewhere around the world. Sunscreens are considered cosmetics so it is easier to get approved sunscreen actives.

LIMITED ACTIVE INGREDIENTS

The challenge of making sunscreens in the US starts with the limited number of approved sunscreen actives in the monograph. There are 16 appr ...