August 2005
The Industry Responds

Shortly after publishing my review of the Jack Black men's skin-care line in the March/April issue of this newsletter, I received the following correspondence from the company (edited to address its most critical points):

Dear Ms. Begoun,
There are several false and misleading statements in your review of our formulations. We trust that you will promptly correct untrue, misleading information that is disseminated to the public.

1. Jack Black Cool Moisture Body Lotion: states that the preservatives methylchloroisothi-azolinone and methylisothiazolinone (Kathon CG) are contraindicated for use in leave-on products (Source: Cosmetic Dermatitis, November 2001, pages 257-274). However, these two preservatives are in fact thoroughly researched, widely used in cosmetics/skin-care products, and found to be safe and approved for use globally in leave-on products. The CTFA (Cosmetics, Toiletries, and Fragrance Association) has established a leave-on percentage of 0.5%, and the amount of this preservative used in Cool Moisture Body Lotion is at or below that level. Furthermore, the study you cited above dealt with airborne exposure to Kathon CG from industrial wall-paint products. Based on this false information, we request and expect that a retraction be made and sent to those consumers that received this misleading information.
   
   
2. Regarding the comments you make for our Sun Guard Oil Free Very Water/Sweat Resistant Sunscreen SPF 30+, you suggest that we do not have sufficient film-forming agents in the product and tell readers "don't be surprised if it causes problems when it gets into your eyes." We would never market an over-the-counter sunscreen without doing the necessary, required testing to substantiate SPF value and water/sweat-resistant claims. We have done the in vivo testing and have proven that the product is water- and sweat-resistant at the claimed SPF number. Therefore, the film-formers in the product are indeed sufficient. Your speculation casts doubt on the efficacy and safety of our product, which is unacceptable.

C urran Dandurand & Emily Dalton,
Jack Black Staff

Dear Curran and Emily,
Your letter brings up two interesting points, and I appreciate this opportunity to address them with you and my readers. Regarding your comments concerning what I wrote about Kathon CG, I want to point out that my statement that this preservative is contraindicated is not the same as saying it is prohibited. You are correct: Kathon CG is permissible for use in leave-on products (although it isn't widely used, especially in comparison to many other preservatives). However, the allowable usage level is not 0.5%, as you state in your letter, but rather it is 0.05% (Source: www.rhpersonalcare.com/kathon.html). That extra decimal point makes a big difference! It is certainly feasible that Cool Moisture Body Lotion contains Kathon CG at 0.05% because parabens (another type of preservative) are present as well. However, it is important to keep in mind that, with or without Kathon CG, I do not recommend this body lotion because, as my review also stated, it contains a form of menthol, which can be irritating to skin.

Further, there are several studies indicating that the components of Kathon CG (methylchloroisothiazolinone and methylisothiazolinone) are skin-sensitizing ingredients when used in leave-on products, even when the amount is low. According to an article on www.dermis.net, "the preservative was responsible for an epidemic of contact sensitivity, in some geographical areas, in the 1980s and early 1990s. Problems occurred mostly when the preservative was used in leave-on products at concentrations higher than 15 ppm [parts per million]. It is now mainly used in rinse-off products at lower levels (up to 15 ppm but usually less than 10 ppm). At these lower levels and use conditions, the prevalence of hypersensitivity is acceptably low and individuals allergic to the preservative may tolerate rinse-off products (e.g., shampoos) preserved with it." That sounds foreboding and somewhat encouraging at the same time, depending on how much of the preservative system is used.

However, the same article goes on to state (and I concur with this judgment): "There is no easy mechanism to assess quantitative exposure; it is exposure to an allergen in dose per unit area that is of pivotal importance for induction and elicitation [of an allergic response]. Because of this, for an individual allergic to the preservative, it is most practical to simply avoid using products identified as containing the preservative from the label. Levels of the allergen in a product may be too low to be able to elicit a reaction but the level will not be known." Because cosmetics companies do not have to reveal the percentages of nonactive ingredients on labels, a consumer has no convenient way to ascertain exactly how much of the potentially problematic ingredient is in the product. Therefore, when I come across products with suspect ingredients, I typically indicate this in the product review.

For those not allergic to Kathon CG, this may make it sound as if it's OK for your skin if a leave-on product you're using contains it, but there is further evidence that this preservative complex is sensitizing for skin (Sources: Chemical Research in Toxicology, volume 18, issue 2, February 2005, pages 324-329; British Journal of Dermatology, volume 149, issue 6, December 2003, pages 1172-1182; www.emedicine.com/derm/topic84.htm; and American Journal of Contact Dermatology, volume 11, issue 2, June 2000, pages 115-118). Despite the fact that Kathon CG is allowed to be present at low levels in leave-on products, I stand by my advice to consumers to avoid such products, especially because there are effective, less sensitizing preservatives that are widely used.

As for the source I used to support my statement about Kathon CG in the newsletter review of Jack Black, your statement that the study "dealt with airborne exposure to Kathon CG from industrial wall paint products" is only partially true. The study was designed not only to measure airborne exposure to the substance from freshly painted walls but also to evaluate its potential to cause contact dermatitis, to estimate the level of exposure from products, and to compare epidemiological results to those of other preservatives. The conclusions drawn supported replacing the Kathon CG with other preservatives, both in wall paint and in cosmetic products.

Regarding the comments I made for your Sun Guard Oil Free Very Water/Sweat Resistant Sunscreen SPF 30+, I stand corrected. I was remiss in stating that this product's lack of film-forming agents would inhibit its sweat-resistant properties. In fact, because this product is a water-in-oil emulsion, it is inherently sweat-resistant; therefore, film-forming agents are not required (though in high-SPF sunscreens they can help boost a product's SPF value by improving spreadability of the active ingredients-which is what I was focused on, and I apologize for my short-sightedness). I also want to point out that the FDA does allow a sunscreen to bear a sweat-resistant claim if the product tested as water-resistant (Source: Code of Federal Regulations, Title 21, volume 5, April 1, 2004). However, sweat-resistant doesn't mean the product will not (as you claim on your Web site) "run or drip into eyes." All a sweat-resistant claim means is that the product will not be degraded by perspiration over a certain period of time (typically 40 to 80 minutes, depending on how the sunscreen tested). If you apply a sweat-resistant sunscreen and are active outdoors, you will still perspire, and if the sunscreen/perspiration mix inadvertently gets in your eye, there is no question it will cause a stinging or burning sensation.