Why Sunscreens Are Tricky For Small Businesses

Sunscreen Formulations

Sunscreen products are a staple in many consumers’ skincare routines. They offer protection against the harmful effects of UV radiation, helping to prevent sunburn, skin damage, and premature ageing. That last one is probably the big motivator for a lot of their use. The popularity of sunscreens has grown significantly over the years as awareness of the importance of sun protection has increased. The global sunscreen market is expected to reach 23 billion dollars by 2030. That’s a lot of sales – an appealing opportunity for skincare entrepreneurs.

Sunscreens date back to the 1930s when the first commercial sunscreen products were introduced. The 1st to become widely distributed was L’Oreal’s Ambre Solaire, which remains popular to this day. Since then, sunscreen formulations have evolved to include a variety of UV filters, both chemical and physical, to provide broad-spectrum protection against both UVA and UVB rays. Reflecting, or scattering UV radiation to prevent it from reaching the skin is the basic motor of this type of product.

Why are sunscreen products appealing as a business?

Sunscreens are appealing as a business because they address a fundamental need for sun protection, which is increasingly recognised as essential for maintaining skin health.  This is a real problem looking for a solution. The market for sunscreens is large and growing, with demand spanning various demographics and regions. Sunscreens are also a consumable product, meaning that customers need to repurchase them regularly, providing a steady stream of potential revenue for businesses.

Why don’t many small businesses launch sunscreen products?

Despite the appeal of the sunscreen market, small businesses often face significant barriers to entry. They aren’t easy to formulate, especially with the heroically high SPF levels that are standard these days. People not surprisingly go for the highest number when given a choice.  But getting those high numbers means using lots of sunscreen actives, which make the product less enjoyable to use.

Sunscreens are heavily regulated products that require extensive testing and documentation to substantiate their efficacy and safety claims. The costs associated with formulation development, stability testing, SPF testing, and regulatory compliance can be prohibitive for small businesses with limited resources. Additionally, the sunscreen market is highly competitive, with established brands and large corporations with their deep marketing pockets dominating the space, making it challenging for new entrants to gain market share.

How can you make an SPF claim?

To make an SPF (Sun Protection Factor) claim for a sunscreen product, you need to conduct both in vitro and in vivo SPF testing. In vitro testing is done in a laboratory to measure the product’s ability to protect against UVB radiation. In vivo testing involves applying the product to human subjects and exposing them to UV radiation to determine the SPF value based on the difference in UV exposure needed to cause sunburn on protected vs. unprotected skin. In vivo testing is always expensive, especially so for sunscreens that have to follow a strict protocol such as ISO 24444.

Following a recognised and well-tested protocol is essential and reduces the risk of invalid results. But it can’t get away from the basic nature of in vivo testing. Humans are highly variable, and the results of tests are consequently highly variable. Even the most skilled and experienced formulator can only make a guess as to what kind of SPF the new formulation is likely to achieve when tested in vivo. They can get it wrong. And results vary by pure chance as well. Every SPF determination is something of a lottery.

The other issue is that there are a fairly small number of labs that offer the testing, and the lead times for a slot vary.  You might have to wait quite a few months to get your product on the grid.

So you are faced with having to run an expensive test that might not give you the result you are hoping for, and a potentially long delay before you can try again.

How long does an SPF test take?

Stability testing is required to ensure the product maintains its SPF value over its shelf life. Complying with regulatory requirements and providing necessary documentation is crucial when making SPF claims – and all this needs to be done before you risk the in vivo testing.  So many months will have been consumed before you even get to spin the wheel.  But once you are ready, it will still be likely to be another 2-3 months before you get the results. You can probably speed this up if you don’t mind taking more risk.

How do you make an anti-ageing claim?

You also need to conduct broad-spectrum testing to demonstrate protection against both UVA and UVB rays if you want to make claims about long-term skin damage.  This is an in vitro test.  It’s quite a difficult test by in vitro testing standards, but it is at least a lot easier than the SPF testing.

Can you make sun protection claims without a specific SPF number?

It is possible to make sun protection claims without specifying an SPF number. You can claim broad-spectrum protection, general UV protection, or highlight the presence of known sunscreen ingredients in your product. Claims about preventing sun damage or positioning your product as a complementary product to primary sunscreens are also options. However, any sun protection claims must be substantiated and comply with regulatory requirements to avoid misleading consumers.


While the sunscreen market presents an attractive opportunity for skincare entrepreneurs, the technical and regulatory challenges involved in developing and launching a sunscreen product can be significant. However, entrepreneurs are often the type of individuals who thrive on overcoming obstacles and finding innovative solutions. You might be able to come up with a way of doing things that works for you. But to do so, you do need to be aware of the magnitude of the challenge you’ve chosen to take on.

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