The New FDA Sunscreen regulations are about to go into effect.
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.
Now Better!
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.
Absolutely LOOOOOOOOOOVE the not new improved unchanged Solar RX
Seems like Keys products just keep getting better & better & better!
Are you currently selling the improved and unchanged Solar RX Moisturizer with Sunscreen or is it still the Moisturizer Sunblock?
Dear Lori,
Yes, we have been shipping the revised process version for about a month. Some retailers still have the previous version on the shelves. The easiest way to tell is that the latest version has a sticker on the cap with NOW in large letters and/or the front now says Sunscreen instead of Sunblock.
Regards,
Mickey
I have been using your Solar Rx for a couple of months now and I really like the feel of it. However, I still struggle mentally with using a nano based sunscreen. I was just reading an article suggesting that making nano particles out of rutile titanium dioxide/zinc oxide is safer than using anatase particles.
Would you please let me know how your nano particles are made?
Thank you,
Stephanie
Hi Stephanie,
Anatase is one of the three mineral forms of titanium dioxide, the other two being brookite and rutile. Zinc oxide is not a pyramidal structure crystal and does not fall under the same crystalline structures of TiO2. This is one of the major reasons we do not use TiO2. The spherical structure of Zinc contrasts the sharp edges of TiO2 do not structurally compact well when used together.
I actually do not know of any sunscreen makers using anatase method. Crystals of anatase can be prepared in laboratories by chemical methods such as sol-gel method. Examples include controlled hydrolysis of titanium tetrachloride (TiCl4) or titanium alkoxides. Such synthetic anatases are of considerable interest for photocatalysis and for Grätzel-cell photovoltaics and would be considered expensive for sunscreens.
We use a proprietary method of making our uncoated ZnO, used primarily for the sun blocking and therapeutic aspects. The method we use is a vapor deposition process that achieves equally sized spheres without chemical fracturing. They achieve tighter compaction than conventional ZnO and do not have sharp edges like TiO2.
I hope this helps.
Regards,
Mickey
Hi! I love your product and was wondering if you could tell me the critical wavelength of your moisturizer? I am choosing zinc products now and finding all of the information so confusing.
Also, if you could possibly explain what changing the particle size means for Uva protection verses uvb protection.
Thank you in advance,
Jill
Dear Jill,
Dear Beatriz,
The wavelength of our particle ranges from approximately 30 nm to 420 nm. We have done some testing with helium argon welders down into the soft xray area, but nothing we are able to publish at this time.
We have written a number of articles in http://www.cleangreencafe.com about the subject of particles always attempting to simplify the subject. Said, it is fairly complex and a bit confusing even to many “experts.” I will try to bulletize our beliefs herein:
• The particle size range is driven by the scientific law of compaction. Generally speaking, the smaller the particle the closer they fit together increases the coverage and therefore the protection. Some people argue that multiple layers of larger particle have an overlapping effect and therefore have equal coverage. This is true, but that is where the sunscreen/sunblock moves from transparent to a white cast. Our Solar Rx is not a go to beach sunscreen and it is designed for everyday use. Our customers do not want to look like mime’s
• Particle coating versus uncoated is a big concern for us. We use uncoated because of the law of compaction above and for the therapeutic reason. Of concern is that we purchased the substance used by most zinc oxide makers to coat the particle. We then coated a glass plate with it and cured it per manufacturers instructions. We then sent UV light through it and then measured to see how much UV was sent through. It was nearly 100% transmission. Extrapolating, the coating on the ZnO particles would make then somewhat transparent and “leak” UV. Again, some use the argument that layering improves coverage. Again, as a cosmetic moisturizer with sun protection, we do not want any whitening.
There are some other factors that come into play. The above are the two major facets.
I hope this helps!
Regards,
Mickey
I love your solar RX but have concerns because am seeing articles/research on uncoated zinc nano particles causing free radical damage on the skin vs. coated zinc nano particles, coated with dimethicone which eliminates free radical activity. Can you address this?
Dear Virginia,
I have read some articles written by bloggers about uncoated ZnO producing free radicals, but no real research. If you can provide me a link to the specific research, I can offer more detailed comments.
Basically, the supposition that uncoated ZnO produces free-radicals is not well founded or provable. First, the outer layer of the skin is comprised of dead skin cells. Applying any surface based barrier that does not penetrate the skin cannot cause free radical generation in live skin cells below the surface. So, the potential of damage is not based on good science.
Most coated zinc oxide was originally designed to make the manufacturing process easier because the ZnO particle agglomerate or clump. Most people use a steric coating that encapsulates the particle, but also renders the therapeutic properties of the ZnO useless. Now some manufacturers has decided to use dimethicone to suspend the particles. It is a derivative of silicone and is anything bet green. It is a dirty 30 chemical and suspends the ZnO particles. Here is a link to the EWG Skin Deep database that show the rating and concerns for dimethicone http://www.ewg.org/skindeep/ingredient/702011/DIMETHICONE/
Besides the concern over the chemical, we know for a fact that dimethicone is UVA and UVB transparent. This means that it transmits UV as opposed to blocking it. We have tested dimethicone for UV transmissivity and it transmits >99% of UV. This means that it will reduce the efficacy of the ZnO blocking. In fact, our scientists presented to the EWG a “lens effect” from coated ZnO that may actually intensify the UV on the skin.
I hope this makes sense and helps you.
BTW, I am glad you like Solar Rx!
Regards,
Mickey
Since it is a physical sunblock, when I apply it in the morning, is it going to protect me all day? (If I don’t get wet, rub it off, or sweat?) . It should, because it’s physical, I shouldn’t have to keep re-applying, right?
Hi Lee, Yes, that is correct. As long as you do not perspire or wash it off, it will remain efficacious.
Regards,
Mickey
Hi Mickey, I’ve been using Keys Sunblock (ahem, sunscreen) for several years, and I love it; in fact, I’d love to see a powder sunscreen to set it with and augment the sun protection, but the real reason for my comment here is to ask what you mean in your description of the new product by “more luminescent.” I struggle with the shimmery products today because, as a woman of 50, too much shimmer is, well, too young of a look for me. Thanks, Kimberly
Hi Kimberly,
Most of our input comes from customers like you and our makeup artists who test every new product. Words are always tough to choose, but the general consensus of our customers is that they do not want to look flat or matte which powders tend to do. Our position as is some of the top makeup brands is that skin looks healthier and younger when it is not flat and has a dewy iridescent look. Studies have shown that when people are very happy their skin glows. There are scientific principle of how this happens, but to try and get the “look”, we use aloe and the shape of our zinc oxide particles to create as close to that happy look that we can get. Said, you can always powder down the look, but we personally think that a slight dewy look denotes happier and healthier looking people.
Regards,
Mickey