Last year I wrote and article in July of 2011 about what to expect from the new regulations. The article outlined all of the changes we as manufacturers had to make to make the regulatory changes seamless to consumers. You can read the article titled “New FDA Sunscreen Regulations.”
There are a number of new things to expect to see in place by June 12, 2012. Rather than bore you with details, here are some bullets of the major changes
- SPF used to mean only UVB protection. Now manufacturers have to guarantee that protection is “Broad Spectrum” covering both UVA and UVB
- All the outrageous SPF numbers (i.e. SPF 75, SPF 100+ etc.) are now illegal. The top rating is now SPF 50+
- The use of the term sublock is no longer allowed. We can only use the term sunscreen
- Cosmetic moisturizer like Solar Rx must comply with all of the regulation applying to sunscreens
- Waterproof is a no no term. Now a sunscreen can be water resistent, but the manufaqctuer must prove it and list the minutes of water resistent protectin on the label front
- There is now a very specific Drug Facts label that has to appear on the back of the product with very spefici language. Below is an image of our new label with the drug facts panel. The panel looks very similar to the panel we have used for the last five years, but is different.
The Not New Solar Rx – Improved
Solar Rx is not new in the sense that we have not changed the formulation or concentration of the ingredients. We have been in compliance with the new FDA regulations for the last two years. That said, we do have a new labels and a few process changes.
Here is the new label in flat art. You can click on it to enlarge
On the front panel, you will notice the familiar name and description, but now instead of saying sunblock, we refer to the sun protection factor as a sunscreen. Solar Rx has always been almost identical to Luminos and now we note that on the label as well. We have maintained our SPF 30+ rating and the acknowledgement of UVA and UVB protection.
The left panel has changed a bit also acknowledging that an alternative use of Solar Rx is as a zinc oxide lotion. Solar Rx can be used for this purpose because we use uncoated therapeutic zinc oxide.
The big change is on the right side label. Instead of our Therapy Facts panel, there is the new very restrictive FDA Drug Facts panel with very specific language about sun protection and the effects of UV radiation on skin cancer.
Well, not really! Confused yet? Said, we have been working on the process of how we make Solar Rx ever since the very first batch. The changes in Solar Rx this month were mostly label changes. What we found in the process of reviewing how we make Solar Rx we were able to make a few changes about how it is assembled in our factory. These changes listed below have made Solar Rx smoother, silkier and with an improved feel.
On the top of each Solar Rx will be an additional label like the one to the right that acknowledges the new changes we have made to our process. Our customers are so sensitive to changes in the products that we felt that it was a good idea to acknowledge the fact that we have made some changes and thate the ingredients are still the same and in the same proportions.
So, here is basically what we did.
- We have changed the order of when and how we add some of the ingredients. This changes how some of the ingredients blend. Unlike chemical based products, Solar Rx is assembled more like food is created. In other words, the order of the ingredients is important.
- We have added some ingredients into the cold side of the process instead of the warm portion. This gives the product a bit of a richer feel
- We have always use a low level sound generator to mix our products and to blend them without adding air to the mixture. Air/oxygen in a mix directly effects the shelf like of a product. Most, if not all but Keys, use a homogenizer to whip up their lotions. We have found that this shears the product ingredients, adds air and increase the volume in a container. That air reduces the efficacy of the product as well as shortening the shelf life. We have made a change to Solar Rx by changing the frequency of that infrasonic sound wave. Well below the range of human hearing, infrasonics, agitates the molecules of a solution in a way that we have found how to use it to blend our products without homogenizing with an aerator type of device.
So, we have made some changes to make Solar Rx creamier, more luminescent and with a better feel. The label has changed, but not the efficacy. The look is a little different outside and improved on the inside without compromising the quality that you have come to trust from Solar Rx.