RMS Products are Safe: Benzene Statement

July 2021

Rocky Mountain Sunscreen Statement on Benzene:

Recently test results were released by a lab that found benzene, a known carcinogen, at varying levels in different brands and batches of sunscreens. The list of products that have benzene mostly consisted of spray sunscreens and aloe vera gels, but there were some lotions on the list as well. Both mineral and regular sunscreens were found to contain benzene, and both mineral and regular sunscreens were found to not contain benzene.

Rocky Mountain Sunscreen was not tested by this lab for benzene. Rocky Mountain Sunscreen or Coral Isles were not on any list, however, we have no reason to believe that benzene is in any RMS or CI products. Our lab is working on finding a third-party testing company that will confirm this.

We stand behind our products that are tested by the FDA and ensured to be safe for use by children and adults alike. Their tests are very strict and standards very high, and we meet them all.


Common Questions:

How did benzene get into the sunscreens on the list, if it is not a sunscreen ingredient?

We cannot be sure until the sunscreen labs that were affected release more information. Rocky Mountain Sunscreen was not on any list, however, we have no reason to believe that benzene is in any RMS or CI products.

  • NONE of our sunscreens at Rocky Mountain Sunscreen or Coral Isles have added fragrance.

Benzene is hidden in the term ‘Fragrance or Perfum’ on the ingredient label and used in almost every product from skin care to baby care, cleaning agents, laundry, makeup and more. Benzene is a component of man made fragrances; derived form coal tar, it is a known human carcinogen – it can cause cancer.

https://www.safecosmeticsaustralia.com.au/key-issues/benzene

Benzene is an important starting material for many perfume ingredients. One of the most important perfume ingredients derived from benzene is 2-phenlyethanol. Phenylethanol is a major component of rose oils and is widely used in perfumery for its blending qualities.

http://www.chm.bris.ac.uk/webprojects2003/teo/realbenzenes.htm#:~:text=Benzene%20is%20an%20important%20starting,perfumery%20for%20its%20blending%20qualities

More than 95% of the chemicals in synthetic fragrances are derived from petrochemicals such as benzene derivatives and aldehydes. Synthetic fragrances are largely to blame for an array of adverse health issues, this somewhat vague term is used on cosmetic labels to hide ‘trade secrets’ or to cover up the amount of chemicals they are adding to their products and to hide specific chemicals from the product label. And, it’s legal. NICNAS warns; “If a safer chemical or process can be substituted for one which involves benzene, then this should be done; Avoid skin contact by wearing benzene-resistant gloves and other personal protective equipment.”

https://www.organicbeautyaward.com/articles/how-to-avoid-benzene-in-cosmetics-and-what-the-experts-say-about-this-chemical-273

  • More than likely, benzene is getting into the affected sunscreens (that do not have benzene in their formulas) due to cross-contamination on the conveyor/processing belts at the labs they were made in, as typically, the labs that create sunscreens also create other skincare products (many of which do have benzene in them). Sunscreen companies, including most of the big names and many of the smaller ones, have their own formulas but go to a lab to actually get their products made and tested since the larger labs are FDA certified and can get the ingredients at a cheaper bulk cost.

Martyn Smith, a professor of toxicology and the Kenneth Howard and Marjorie Witherspoon Kaiser Endowed Chair in Cancer Epidemiology at University of California at Berkeley, said he wasn’t surprised by Valisure’s findings, because benzene is difficult to avoid. “It’s the building block for many chemicals in our world, including many drugs like aspirin and other things. It’s also found in all fossil fuels, and anytime you burn anything — from a wood-burning fire to a candle — you are exposed to benzene.”

https://www.washingtonpost.com/lifestyle/wellness/benzene-sunscreen-safe-carcinogen-/2021/06/04/33723cb6-c55f-11eb-9a8d-f95d7724967c_story.html

All that being said, the lab that Rocky Mountain Sunscreen uses is NOT the lab that any of the sunscreens that are being recalled use, and it does NOT make any other products with benzene so there is no risk of cross-contamination on the machines.

Why do we think sprays are most affected?

Spray sunscreens smell like alcohol. Many companies rely on fragrances to cover this smell up. Rocky Mountain Sunscreen does not add fragrances to any of our sunscreen products.

The clear liquid inside the bottles of spray sunscreen that smells like hand sanitizer is liquid spray sunscreen, and smells a bit alcoholic because alcohol is what makes it liquid. It needs to be liquid in order to be sprayable. The nature of spray sunscreen is different than lotion sunscreen – lotion won’t have a strong alcohol smell like spray will since it does not need to be liquified. Many companies choose to cover this smell with fragrance, but Rocky Mountain Sunscreen does not. Once sprayed onto the skin the alcohol dissolves and the sunscreen remains. This is how spray sunscreens work, like all of the spray sunscreens you will find at your local and big box stores. Inside the aerosol cans on the shelf, the sunscreen inside is also clear liquid and smells a bit like alcohol.

Does Avobenzone contain Benzene?

No. Benzene has nothing to do with Avobenzone, nor does it have anything to do with chemical sunscreens. Avobenzene is a completely different chemical from benzene. Aspirin or almond flavoring are more similar to benzene than avobenzone.

“[Benzene] HAS NOTHING TO DO WITH CHEMICAL SUNSCREENS.

It’s not because of particular sunscreen ingredients or chemical sunscreens. Both chemical and mineral sunscreens show up on the list, and Valisure also checked samples of raw sunscreen ingredients for benzene. There are some sunscreen ingredients that have names that look like the word benzene, but they’re not the same thing”.

https://labmuffin.com/will-benzene-in-sunscreens-give-you-cancer-with-video/

Should you stop wearing sunscreen? No.

Not all sunscreens were found to contain benzene; in fact, the majority of them did not contain it. “An individual make and car can have a part recalled, but you aren’t likely to stop driving.”

Even those that did contain it had such a negligible amount that the danger level of getting cancer, is the same as spending a day breathing in air in a city. The amounts found were such small traces, that it was not a toxic level with regular use.

Smith said he compared the highest level of benzene contamination mentioned in Valisure’s report to urban air breathing for 24 hours, and estimated that applying 10 ml of the contaminated sunscreen (approximately one application) could — in the worst-case scenario — result in absorbing about half the amount of benzene one gets from breathing city air in for a day.

https://www.washingtonpost.com/lifestyle/wellness/benzene-sunscreen-safe-carcinogen-/2021/06/04/33723cb6-c55f-11eb-9a8d-f95d7724967c_story.html

Skin cancer, however, is the most common cancer in the United States. According to the Skin Cancer Foundation, more people are diagnosed with skin cancer every year in the United States than all the other cancers combined and every hour, more than 2 people die of skin cancer. Regular daily use of SPF 15 or higher sunscreen reduces your risk of melanoma by 50%.
https://4ag46i294nta1038p13v77x1-wpengine.netdna-ssl.com/wp-content/uploads/SCFSkinCancerPrevention.pdf

We stand behind our products that are tested by the FDA and ensured to be safe for use by children and adults alike. Their tests are very strict and standards very high, and we meet them all.


From our lab:

This is in response to the actions taken by Rocky Mountain Sunscreen (RMS) to address the concerns identified with the Valisure Citizen Petition pertaining to the recent finding of trace amounts of benzene in certain sunscreen products.

To begin with, benzene is not an ingredient used in sunscreen products, and at this point, the manufacturers of the finished products and the manufacturers of sunscreen chemicals have not identified, or at least publicly identified, its source in the finished products. However, RMS has been making inquiries of its vendors to try and ascertain if any specific raw material or packing may be the contributing source. It has also been monitoring FDA statements, the industry trade/press, and public media for new information on the issue as it becomes available. Finally, RMS has been identifying labs that can perform the test or the presence of benzene.

However, while RMS recognizes the importance of this issue, we think it is necessary to keep in mind a broad perspective of the situation. There is presently a large amount of information in the public domain that is helpful in this regard. For example, the following excerpts from statements made by various organizations are informative.

First, a statement by the Personal Care Products Council, states:

“…Benzene is not an intentionally added ingredient in sunscreen products, however, the U.S. Food and Drug Administration (FDA), as well as product manufacturers, are aware that benzene may be found in food and drugs at very low levels. FDA offers guidance on the level of residual solvents as a companion document for the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). PCPC strongly supports FDA/s guidance and activities in monitoring for conformance to these recommendations.

Sunscreens on the market today are backed by decades of safe use to help adults and children guard against the dangers of sun exposure. The FDA, Centers for Disease Control and Prevention (CDC), US Surgeon General, American Academy of Dermatology, Skin Cancer Foundation, and health professionals worldwide consistently advocate for the use of broad-spectrum sunscreens as part of a safe-sun regimen. These products play a critical role in the fight against skin cancer.

Nonprofit health organizations and government agencies recommend using sunscreens as part of a safe-sun regimen. CDC’s Sun Safety recommendations note the importance of daily sunscreen use to help prevent most skin cancers, even on cloudy and overcast days…”Source: https://www.personalcarecouncil.org/tag/sunscreen/

Second, the threshold defined in the ICH guideline (Impurities: Guideline for Residual Solvents, Q3C(R8)) for Benzene is a maximum of 2 parts per million (ppm) for drug substances excipients and drug products.

Source website: https://database.ich.org/sites/default/files/ICH_Q3C-R8_Guideline_Step4_2021_0422_1.pdf

Third, the Johnson and Johnson voluntary recall notice posted on the FDA website stated the following:

“Based on exposure modeling and the Environmental Protection Agency’s (EPA) framework, daily exposure to benzene in these aerosol sunscreen products at the levels detected in our testing would not be expected to cause adverse health consequences. Out of an abundance of caution, we are recalling all lots of these specific aerosol sunscreen products…”

Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/johnson-johnson-consumer-inc-issues-voluntary-recall-specific-neutrogenar-and-aveenor-aerosol

Note that the J&J products were found to have substantially higher levels (>2ppm) of benzene.

In the Citizen Petition, Valisure has stated that no residual level of benzene is acceptable; however, FDA has not established a limit for standard drug products of set a daily exposure limit. They have petitioned the FDA to updated the provisions of the ICH guidelines.

Any discussion of benzene is not complete without mentioning that it is a ubiquitous substance and is formed from both natural processes and human activities. Natural sources of benzene include volcanoes and forest fires. Benzene is also a natural part of crude oil, gasoline, and cigarette smoke. Benzene is widely used in the United States. It has also been identified in air samples of both rural and urban environments and indoor air.

In conclusion:

  • Benzene is not an added ingredient in RMS sunscreen products
  • The current regulatory guideline for the benzene level in drug products is 2ppm
  • The FDA has not ordered a recall of the sun care products found to contain trace amounts of benzene
  • The voluntarily recalled J&J products have benzene levels substantially higher than 2ppm
  • Sunscreens play a critical role in the prevention of skin cancer

Based on the above, we do not believe any further action is needed at this time. We will continue to monitor the situation and will update communications in the event new relevant material is discovered. Also, please feel free to contact us if you have further questions.

Sincerely,

Rocky Mountain Sunscreen


Here is more in-depth information about benzene in sunscreens from chemists:

Labmuffin Blog Post:

https://labmuffin.com/will-benzene-in-sunscreens-give-you-cancer-with-video/

Chemist Confessions In-Depth Video:

 

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