Product Development Office Hours with Yoana Dvorzsak: The Basics of SPF Testing

Highlights:  

• SPF testing is required by law in order to launch a sunscreen in the US.   
• Solésence provides a testing quote for brand partners to clearly set expectations at the outset.  
• Solésence specializes in mineral-based environmental protection — we've put in the scientific research as well as the financial and operational work so that brands don't have to shoulder the burden of SPF product development and testing.  

Let's start with the basics. What is SPF testing?   

Though other tests are commonly done, there is only one test that is required by the FDA to launch a sunscreen in the US, and that's SPF testing, which tests specifically for UVB performance. You can have a static SPF test — which allows for the SPF number up to 50+ but does not allow for any water resistance claims. Per the FDA mongoraph you can also have 40-minute water resistance or 80-minute water resistance. People may recall sunscreens with waterproof claims or with SPF numbers above 50, even up to SPF 100, but much like a “sunblock” claim, that is no longer allowed. So any product you see on the market with those numbers or claims has been grandfathered in. Static SPF and water resistance (if applicable) is the must-have test so that you can get your SPF number, along with the SPF broad spectrum claim, which is an additional but very important test for making any claims involving UVA protection. We think of broad-spectrum as a must-have claim beyond what the FDA recommends because UVA is the trigger for melasma, persistent pigment darkening (PPD) and of course skin cancer.  

How much does it cost to substantiate SPF claims, and how long does this process take?  

It depends on where you plan to launch, and what tests you wish to perform in addition to the minimum requirement. Our standard regulatory package, which includes SPF testing, starts at $16,000 and goes up from there. Every country or territory has its own test. We of course follow FDA testing, which allows for launches in the USA and, with the addition of some regulatory registration efforts, in Canada. If you want to launch in Europe, there is a different monograph you have to follow and you have to adhere to their regulations. The third regulatory body is Australia and New Zealand, and they require a third process which is an extra cost. So, depending on where you are launching, the cost can vary.  

How long does SPF testing take?  

The process typically take 12-20 weeks. This 20-week endpoint is longer than typical due to Covid-19-related delays. We try to have more than one option for each test so we can gain speed there, but all of these in vivo tests are done on humans so there is a slight delay. Most results have still returned in within 14 weeks, but we still guide brands that 20 weeks is the estimated outer limit. If there is an additional test outside of the usual scope then that can extend things. For example, we only have one lab that we have qualified for the biodegradability test, and it is only scheduled twice a year, so that of course takes longer than 20 weeks.  

What SPF testing does Solésence typically do, and who pays for it?  

Our standard regulatory package for all our white label products includes static SPF, broad spectrum, and water resistance testing in addition to Human Repeat Insult Patch Test (HRIPT), phototoxicity studies, and the other testing that is required for the Skin Cancer Foundation Shield. All of this is done as our gold standard to ensure safety and bullet-proof data so that you know a product is safe for use in addition to being truly effective. For any white label or white label + approach, Solésence covers the cost of SPF testing. If we are doing full custom development, the brand is responsible for the cost of SPF testing but we handle the logistical burden.    

If brands have an additional test they want to add for a certain claim, like moisturization or a non-comedogenic claim, that's beyond the scope of our standard package. Some of our formulas include some of this testing, but it's really outside of our standard regulatory testing package. Other testing that's considered beyond the scope of our standard testing package would be biodegradability testing or a pediatrician signature.  

What SPF testing is required for a global launch?  

In Europe, there is an equivalent static SPF and water resistance test, again 40-minute water resistance and 80-minute water resistance. The way they score is different than how the FDA scores but it is pretty much equivalent. There is also a test for UVA performance — which is where you see the PA, PA+, PA++, PA+++ on a product pack. This really equates to the UVA performance of a product. For brands selling in Europe and Asia, the UVA test is preferred. Even in North America, it's sometimes added. In the US, the broad-spectrum test also pertains to UVA protection, so this less frequently used UVA performance test can offer additional support for your claim. Then in Australia, testing is different still. So, it really depends on where you are launching, and that's why launch plans are one of the first questions we ask when speaking with brands about a new product.  

How does Solésence ensure that a product is testing at the proper level?  

We are deeply invested in each and every one of our brand partners seeing success on the market — our success quite literally depends on the success of our brand partners — so we take testing very seriously. We believe it is important to use a third-party lab that has been audited and validated through blind studies, and these are sources we are transparent about once we're under NDA with a brand partner. We are sure to use labs where the numbers will be correct rather than giving us the results we want to hear, and one of the ways we do that is through multi-lab benchmarking studies. All of this is extremely important, crucial really, for our reputation as well as for our brand partners' reputations. 

Another way we ensure accuracy and quality in our testing and products is that we are much narrower and more specialized in our focus than other contract manufacturers, and we really think this works to brands' advantage. We employ other screening techniques that look at a formula, not just its in-vitro SPF, to ensure that micro-scale stability is achieved and maintained through the life of the product. We literally have invested hundreds of thousands of dollars in developing this know-how including the formulation techniques and analytical methods to create a viable product. This specialization and expertise is something brands should look for in a manufacturing partner so they don’t have to shoulder the financial and knowledge burdens that come along with SPF-containing products. 

Thanks, Yoana, for joining us for this Office Hour!