Hi Bob. I was wondering if you could comment on the safety of nano zinc oxide? My husband is hesitant to use Solar Rx because he read something *bad* about nano versions of ingredients, but he can't remember where he read it or exactly what the caution was about.

Thanks very much!

Hi Liz,

Let me see if I can shed some light on the topic.

The question of nano particles used for skincare has been percolating on and off for about ten years. In 1996-1998 there was a theory brought forth by an Oxford University professor that nano particles might be hazardous to humans. Most of the theory seemed to move toward airborne particles and lung tissue. Some further research by a professor named Stark tested the theory.

First, I am very familiar with most of the research around nano-particles. We are affiliated with the National Institutes of Health, The National Cancer Institute, the Skin Cancer Foundation and a number of Universities including the University of Hobart in Australia, Ohio State and the University of Maryland.

The Stark reference has been running through the press for the last few months and has uniformly been misquoted. It sparked a flurry of counter research and has been fundamentally been disproved by research by Australian government sponsored projects. Australia is the leading researchers on nano-zinc oxide and nano-titanium dioxide.

Recently, the Friends of Earth (FOE), whom we are also affiliated with through the Environmental Working Group, launched a campaign to curb the marketing of nano materials in cosmetic products. They have called for an FDA hearing, which had already been scheduled for this coming October, to investigate all nano materials in cosmetics. The FDA has already responded offering that they have found no evidence that nano particles in cosmetics are harmful. We have done a great deal of research ourselves on nano and have reviewed all of the research dating back to the early 90’s. Periodically, the press has picked up the controversy over the last ten years and there has been a flurry of articles after the FOE announcement. If I may add, with no hard reference the Stark Abstract

There are two responses as the inventor that I want to offer. The first is the scientific answer and the second is the emotional answer based on the invention of the product for my wife after defeating Melanoma.

First, the scientific answer is fairly straight forward. Stark’s study deals with the effects of soluble oxides in an airborne environment and the effects on lung cells as it relates to asbestos and silica. It had nothing to do with skin tissue. Also, Stark’s study was based on soluble nano zinc oxide (nano ZnO) and we use insoluble. His finding clearly state that insoluble has little to no risk even when it comes to lung tissue. As an overview, Stark conducted some experiments looking at different nano particles and their effect on cellular structures. The problem with all the articles is that they neglect to tell the reader that the research was not conducted in reference to sunscreen, it was conducted on lung cells and the angle was airborne nano particles. Even of greater interest is that this is not really a study, it is a report of initial probing to develop a yet to be stated hypothesis.

The Australian government conducted studies and also reviewed about 12 other studies that all showed no effects of nano ZnO or nano TnO2. Where the articles come unglued is in three areas. When you apply a Sunblock, you are not applying it in a concentration. Our Sunblock is 15.5% insoluble nano-ZnO which technically equates to about an SPF 60. The second problem with the interpretation by the press of the Stark research is that he took living lung cells (not skin cells) and exposed them to a concentration of sub-10 nanometer ZnO particles. When you apply sunbock, you are actually applying it to skin cells that are not alive. Studies have shown that nano-ZnO does not penetrate through this skin level, so it does not get to living cells. So, for me and my scientific advisors, we do not believe that there is any weight to the theory and that industry companies, the FDA and universities have all stated that there is not clear risk. We also have the experience of time. Zinc Oxide itself has been used for over 75 years, not just as a sun precaution, but in baby ointments and even Calamine lotion. Granted, the particle size tends to be large , but the process to make the large particles also creates some nano particles. So in a sense, we have been exposing ourselves to uncoated ZnO for years. Yes, a bit of rationalization, but all are hard data points versus the fear of conjecture.

My emotional answer is also fairly straight forward. I developed the Sunblock for my wife, Wendy Steele. She survived Melanoma skin cancer as well as other forms of skin cancer. When I developed the product, I was aware of all of the controversy and reviewed all of the information I could find. Unfortunately, in our society, fear, uncertainty and doubt seems to carry more weight than science. The many opinions were just that and the amount of science disproving the opinion is deep. So, it was a clear decision to make our product.

I developed our Solar Rx to protect my wife’s life, not to put it into jeopardy. We offer it to the public with the same intention. At the point that we receive one shred of evidence that nano-ZnO is even remotely hazardous, we will remove the product from the market. To date, I can find no research, any data or any information that it is unsafe.

Besides the lack of real data, the negative effects of UVA and UVB radiation are an order of magnitude more dangerous to human life. There are direct links to Melanoma and UV radiation. Further, there are links to cancer surfacing that tanning beds using powerful UV lamps are elevating cancer risks. In fact, Brittany Lietz is Miss Maryland in the upcoming Miss America Pageant. She recently survived stage 3 Melanoma that she attributes to tanning beds. Next to her in the hospital bed was a 7 year old with Stage 2. It is the basis of her platform.

As a position, if you read our Solar Rx page, you will see that we believe in covering up with SPF 30+ clothing, wearing SPF sunglasses and an SPF hat. We only recommend sunblocks containing only zinc oxide to be used on exposed skin. It has nothing to do with nano, but our recommendation is based on the reality of people lifestyle. We absolutely disagree with using sunscreens to sunbathe. Her is an article written by Wendy Steele that furthers the thinking.

Of greater concern to me are the chemicals in everyday products. Chemical based sunscreens are not eco friendly. 95% of skincare products contain one or more of the Marin Cancer Projects 'Dirty Dozen' Chemicals. Equally, the phthalates, parabens and glycols in everyday personal care products offer much greater risk of cell damage and have hard research proving it. You may also want to check out http://www.searchforthecause.org. This is the offshoot of the Marin Cancer Project who we support and are affiliated with.

So, I believe that Zinc Oxide in any form is not harmful. I actually believe that it is therapeutic. Conversely, I think the risk of skin cancer is high if you do not use broad spectrum protection. That comes only from Zinc Oxide or Titanium Dioxide. Personally, I have much more concern about titanium dioxide and that is why we use only ZnO.

Finally, the Friends of Earth (FOE) are closely affiliated with the Environmental Working Group. Said, the EWG Skin Deep report ranks our Solar Rx Sunblock as the safest on the market with a rating of 0.2 on a scale of 0-5 ( 0 being the best and 5 being the worst.) Also, if you read the FOE statements, you will see that most of their focus is actually on the marketing hype and overuse of the term nano and nano use in cosmetics. As a public watchdog group they are, by nature sensational.

For a more detailed description of Stark’s work, you can go to the National Cancer Institute Alliance for Nanotechnology at http://nano.cancer.gov/news_center/nanotech_news_2006-04-17d.asp

Also, you can Google the subject to see all that has been written. I will warn you that there is a lot and it is mostly written in Geek Speak. I enjoy it, but it is definitely not something that excites most people.

Best regards,

Bob

WOW, thanks Bob, for such a thorough and informative answer. I've been using SolarRx and hope to get my husband on board soon too!

Hi Liz, you are welcome!

Almost everyday we hear of new concerns about many of the man-made chemicals that we use in our health products. I try not to react to any of them. I do have to say that I am continually amazed that many chemicals that are banned from use by manufacturers are allowed in personal care products or personal care applications. I am also amazed at how many 'Dirty Dozen' chemicals are in prescription products.

As an ex-high tech guy, I walk buy nail salons in the mall and smell MEK (Methyl Ethyl Ketone)and wonder, "How can that be?" When I had a manufacturing facility in San Jose, CA, my team had to wear respirators and bunny suits to protect them for MEK. How can workers in nail places be allowed to breath it. Why?

Well, that is one example, but I wish that taht all manufacturers would adopt a policy that less is more. I challenge my team to make everything with less than 10 ingredients. Everything has to be on purpose. Nothing added that does not contribute. I am still amazed at the number of ingredients in products. Most on the market have more than 40 and some even over 60.

I guess from an engineering perspective, less is more and from a chemist perspective, more is better.

Please fell free to ask anything else. If I don't know, I will find out!

Regards,

Bob