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Is Octocrylene Safe?

Posted by on May 27, 2011 · 28 Comments 

Yesterday, we asked what your sunscreen questions were. Here is the answer to one of the questions asked:

Octocrylene has been evaluated by the FDA and is considered safe for use up to 10% in the forumla.  The European Union has allows its use up to 10% in a formula and Health Canada allows a maximum use level of 12%

I haven’t looked at the data and am not a professional toxicologist so am in no way qualified to dispute people who are. The question of safety is different from the question of whether something is an allergen.  There are lots of “safe” ingredients that are used in cosmetics which also happen to be allergens that some people should avoid.

A brief search through the published literature shows that Octocrylene had 2 reported cases of being an allergen in 2003 but according to an article published in the Contact Dermatitis journal, reports of positive patch testing have been increasing.  According to this more recent review in Archives of Dermatology more cases have been identified.  Their conclusion is interesting…

” Octocrylene appears to be a strong allergen leading to contact dermatitis in children and mostly photoallergic contact dermatitis in adults with an often-associated history of photoallergy from ketoprofen. Patients with photoallergy from ketoprofen frequently have positive photopatch test reactions to octocrylene. These patients need to be informed of sunscreen products not containing octocrylene, benzophenone-3, or fragrances.”

So, it seems like their is some legitimate concern and children & some adults with skin that is “easily irritated” (still a minority of the population) will want to avoid it.  This means it’s an allergen to some people not that it is “unsafe”.

Are Sunscreens adequately tested?
Chemical sunblocks are tried and tested more thoroughly than any other ingredient that’s found in cosmetics.  They are drug ingredients so the FDA requires specific testing and validation.  Are they tested enough?  I don’t know but according to the independent, toxocologists that helped develop the testing guidelines, YES they are tested enough for you to feel confident about using them.

No level of testing can guarantee that everyone who uses a compound will react perfectly well to exposure.  The testing that is done now is determined to be as good as needed.  But identification of reactions in the marketplace is part of the testing.  The FDA and other groups will take the results into consideration and revise testing standards if it makes scientific sense.  That’s just how science works.  It is not perfect.

Why Use it?
There are a variety of reasons a cosmetic chemist might want to replace titanium dioxide.

1.  Aesthetic.  It is not always clear and leaves white streaks on skin that consumers do not like.

2.  Performance. It doesn’t cover the entire spectrum of UVA and UVB so additional protection is needed.  In this case something like octocrylene would be added in addition to a mechanical sunblock.

3.  Water resistance.  Octocrylene helps make formulas more water resistant than titanium dioxide.

In truth, Octocrylene is a more expensive sunscreen and difficult to formulate so formulators stay away from it.

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More about the author:  Perry received his B.S. in Chemistry from DePaul University. He has written and edited numerous articles and books, teaches SCC continuing education classes in cosmetic science, and is the primary author at ChemistsCorner.com a website dedicated to training current and future cosmetic scientists. Read more from this author

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  • http://twitter.com/RealizeBeautyEd AmandaFoxon-Hill

    That seems to be a fair appraisal of this ingredient that is put into a formula to make it more stable.  I think that the logical progression for the sunscreen industry is to move to more stable formulations which sounds like a ‘huh, of course dummy’ thing to say but the filters were simply not available until recently.  Most brands are working to do this but new filters do come with a price tag and at the end of the day if people can’t afford to use sun protection they WILL be worse off.   I think it is easy to forget that years of testing, millions of dollars and thousands of research hours go into developing these things to help us enjoy our wear nothing, stay-outside-all-day lifestyles! Like any science, sunscreen development is a work in progress but I think we’ve come a long way so far and I’m proud to be a part of it all.

    • Lynda

      hi-im-from-oz-and-have-just-broken-out-in-allergy-dematitis-rash-all-over-body-have-been-doing-my-research-and-worked-out-its-the-octocrylene-20mg-in-the-woolworths-spf30+-that-did-it-as-everytime-i-put-it-on-i-started-itching-over-the-space-of-a-week-and-then-it-went-full-blown-im-a-mess.

      My-son-said-he-stopped-it-cause-he-was-starting-to-itch.

      Problem-now-is-its-itchy-and-is-starting-to-join-up.
      Have-been-on-25mg-steroid-4-days-tapering-down-to-1/2-for-4-days-to-avoid-more-flareup-although-it-looks-hideous-and-i-dont-know-what-to-use-to-get-rid-of-it.

      Sudocrem-zinc-oxide-seems-my-only-relief-but-its-still-here-and-still-itches-especially-in-night.

      Any-suggestions/remedies-etc.

      Cetaphil-made-me-burn-had-to-wash-it-off.

      Lynda

  • Anonymous

    I don’t know it Zinc Oxide is water resistant or not but it does provide full protection and I think it does leave patches on the face but so does the other sunblocks which do not have these ingredients so how to identify them and avoid those sunscreens???
    And, you said that chemical sunblocks are drug products so that includes all the sunscreens produced in the market????

    • Anonymous

      I think that’s how the FDA has it set up, regulation-wise.

      • Sarah

        Only an expert could really answer, but my guess is all sunscreens, zinc oxide and titanium dioxide included, are regulated in the same way–right?  Maybe we could get some clarification on that.

        • Rich Summers

          Simple answer, yes. They are regulated in different ways in different countries, but in each all sunscreens will be treated identically. In the EU all sunscreens are listed under the sunscreen annex of the directive ( regulation ), in the states all sunscreens have to comply to the ( very outdated IMHO ) FDA sunscreen monograph ( an update of which has been on going for about 20 years I believe ), Japan follow the Australian rules and Australia are regulated by the TGA ( from the deep depths of my very untrustworthy memory its been too long since I dealt with Oz on sunscreens, Amanda will probably correct me on this one ).

          Water resistance is a specific claim that has a very specific test protocol. It actually only applies to sunscreens. It is something along the lines of “after immersion in wtaer for X time there must be Y% of the original SPF” if you don’t meet the criteria you can’t claim water resistancy, and it has nothing to do with which UV filters you use ( it is actually normally more to do with the film formers and emolients used ). If anyone is interested I can dig the water resistance method out, I have got a copy somewhere in the depths of my very untidy desk.

    • Sarah

      I’ve seen plenty of zinc oxide sunscreens that are marketed as water resistant.  Which sunscreens do you want to avoid?  The active ingredients should be listed, at least here in the U.S.

  • chemist

    I still wonder why nobody ever wants to talk about the study out of Switzerland last year that found many sunscreens, including, oxycrylene in human breast milk (M. Schlumpf et al./ Chmeosphere 81 (2010) 1171-1183).  Many of the other chemicals founds could be from environmental exposures.  I do not, however, know of any industrial uses of sunscreen ingredients other than cosmetics.  This would seem to point very strongly that the body does absorb these chemicals through the skin, and the damage could be much more widespread than we think.  Also exposures greater than we think to the most vulnerable of our species.  
    I strongly disagree that the FDA has the capacity of will to adequately evaluate and test all the materials introduced into commerce in regards to cosmetics.  I don;t think more regulation is the answer, but i would like to see this industry take its head out of the sand (or its pocketbooks) and truly look at what materials it calls “completely safe” .
    Sorry a bit of a tangent, but every time I see an article on sunscreen safety now, my mind goe to that study, and i wonder why so many conveniently ignore it.
      
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    • Colinsanders

      I remember that study coming out and I don’t think there were many inhibitions about talking about it.  There just isn’t much to say about it. 

      I have just looked again at the abstract.  It doesn’t give any levels in the abstract and I can’t justify paying $40 for what looks like a fairly uninteresting piece of work.  The conclusion is simply that women who use sunscreens have some components of those sunscreens present in their breast milk. That is hardly surprising.  Molecules are very small and there are lots of them.  Within a few days of the accident at the nuclear plant in Japan isotopes from the reactor were being detected in Oxford, England. That is how quickly they move. 

      I think all this paper shows is that analytical chemistry has become highly advanced and can detect very low levels of just about anything you care to look for.  

      • Dene62

        Colin – the “offending” substances are detected at the usual levels – low ng/g – in other words, miniscule! Some are in double figures, but most are single figures ng/g.

    • Dene62

      @ Bruce – I am not aware that “nobody wants to talk about” Schlumpf’s study. I thought that you were going to write an article about it (and I was also going to consider doing the same, but I will confess that I have not yet got around to it). On the face of it, her study DOES seem to confirm that the substances may be absorbed through skin (although, in the apparent absence of negative controls, this may not be as clear cut as it may appear), but you take a huge leap of logic to then claim that “the damage could be much more widespread than we think”. What damage? Where is the proof that the concentrations allegedly detected are high enough to cause actual damage? Simply demonstrating a presence is a far cry from proving any kind of adverse causal effect, although that doesn’t stop some people from drawing that conclusion (reference Darbre’s classic work with parabens in breast cancer tissue, although I would not be so rude as to draw a comparison of the quality of Schlumpf’s work with that of Darbre!).

      I am happy to talk about Schlumpf’s work – but in the correct context.

      • chemist

        Dene.. What damage?  Exactly.. we do not know if there is damage, or not damage, but it would seem that denying that anything is absorbed through the skin from cosmetics is no longer valid.  That is my only point Cosmetic safety has many facets, not just in use, which is all many in the industry only concern themselves with.

        Colin.. I sent Dene a copy of the report, I could send you a copy if you would like.  I think you have my email.

        Peace
        B

        • Dene62

          Bruce – my point is that you originally used the word “damage” as though it is proven that there IS damage from the presence of these substances. As far as I am aware, there is no proof of this (certainly not at the concentrations claimed by Schlumpf). I am not aware of anyone denying that there IS some absorption (to varying degrees) of some cosmetic ingredients – Schlumpf gives us nothing new in her work. Who on PCT has ever claimed that no cosmetic ingredients are absorbed?

  • Lise M Andersen

    THANK YOU! I knew I would get a thorough answer from PCT. :)

  • Sarah

    I thought one of its advantages was its ability to photostabilize avobenzone.

  • Rebecca

    I tried a sunscreen with 10% of this in the product ANTHELIOS XL and had an allergic reaction, same as I have with all the chemical sunscreens. Burning skin and runny eyes. I think if you have allergies to chemical sunscreens it may just be to all of them. I can’t use Helioplex either. So for better or worse Zinc and Titanium are a godsend to those of use that can’t use the other chemicals.

    • Sarah

      It could be an irritant rather than an allergic reaction.  It is hard to envision someone having a true allergy to all chemical sunscreens, because they are not one chemical or even one family of chemicals–and as far as I understand it, true allergy is an immune response and tends to be specific to particular chemicals (and sometimes to their close chemical cousins).  But as someone with rosacea, I do get mild irritation from chemical sunscreens on my face, and if I use them too near my eyes, I also get burning/stinging.  Again, I define this as irritation rather than allergy.

      • Harald Jezek

        In addition to my other post to Rebecca, I should also mention that the irritation problems might come from mineral oil which is still commonly used in cosmetic products, although it´s known to be comedogenic. This, together with sweating and the sunscreens might lead to irritations (also known as Mallorca Acne) in some people.

        • Sarah

          I had always heard that for the most part, mineral oil is not particularly comedogenic.  Did you see this article?  http://personalcaretruth.com/2010/11/the-top-5-myths-about-mineral-oil-part-1/  Regardless, in my case, I get no irritation from mineral oil or petrolatum (at least in the concentrations I’ve encountered in products I’ve used)–but I do get irritation from chemical sunscreens (if used often enough and in enough quantity), AHAs, BHAs, retinoids, and some plant essential oils (lavender, peppermint).  There are probably other things I’ll remember later, but those are the ones that come to mind.

          • Harald Jezek

            Hi Sarah, yes, I´m aware that opinions are divided whether mineral oil is actually comedogenic or not. In any case, this will also depend on the oil grade as well as the concentration used.
            Truth is, some people are just more sensitive than others. A particular product might work just fine for one person and cause irritations in another one. Since cosmetic formulations are usually rather complex concoctions, it might be a good idea to keep a list of products that cause you problems and write down the ingredients mentioned on the label. Maybe that helps you, at least, narrow down what causes your irritation and avoid these particular ingredients. It seems you already have some idea anyway what might cause you problems.
            AHAs, retenoic acid (Vit. A) can be used in peeling products, which already shows you that, depending on concentration, they can be aggressive to your skin.
            So, it´s really a bit of trial and error until you figure out what works for you and what not.

          • Sarah

            Agreed.  For example, people with rosacea are not all alike–and I’ll often see recommendations that such-and-such is rosacea safe or rosacea unsafe.  I think that’s a bad idea because we’re not all alike and, as you say, the formulations may differ.  For myself, I’ve got it down to a science now with products that work for me and those that don’t.  Even retinol I can use, but I have to restrict myself to several times per week at a fairly low concentration.

          • Sarah

            Agreed.  For example, people with rosacea are not all alike–and I’ll often see recommendations that such-and-such is rosacea safe or rosacea unsafe.  I think that’s a bad idea because we’re not all alike and, as you say, the formulations may differ.  For myself, I’ve got it down to a science now with products that work for me and those that don’t.  Even retinol I can use, but I have to restrict myself to several times per week at a fairly low concentration.

    • Dene62

      I agree with Sarah’s response below, but would add that it may be the case that there is another ingredient common to all the products you have used to which you react. It is extremely unlikely that you have a skin response to ALL “chemical” (ie non-physical) sunscreens.

      • Sarah

        Yes, a lot of the broad spectrum chemical sunscreen formulations seem to have multiple ingredients in common–including octocrylene, which I think is favored especially because it helps to stabilize avobenzone (and maybe others that would otherwise tend to break down in sunlight)–is this right?

    • Harald Jezek

      As Dene and Sarah pointed out, the problem might very well be related to some other ingredient common to all the formulations you had problems with.
      Usually and especially in products with high SPF, chemical filters are combined with physical ones (mostly Titanium dioxide). This is mostly because all the chemical filters have a maximum allowed concentration and sometimes it´s just not possible to reach the desired SPF just with chemical filters.
      Then, there is also the question of esthetics. Too much of chemical filters don´t feel so good on the skin. In the past, Titanium Dioxide was also frowned upon because it left a white residue on the skin (no wonder since it is the component in dispersion paintings you use to paint your walls white). This, however, improved a lot with new grades that are micronized and coated (which helps in formulating as well as skin feel).

  • Jennysmithx

    My 5yr old daughter seems to be allergic to octocrylene. we’ved tried multiple sunscreens and she only got a reaction when octocrylene was present. she got a bad rash on the v-neck area of her chest and her face was red and puffy for several days. seems to be pretty rare condition, and not harmful (just looks bad for several days!) and easy to solve — just avoid sunscreens with octocrylene (although that means no quick spray on kind since those all seem to have octocrylene…)

  • http://twitter.com/DiscordantFlesh Silent Agony

    I am allergic to this it especially on my face I get an intense burning sensation its horrible but I’m glad it works for most since it sounds like a really effective sunblock!

  • http://twitter.com/DiscordantFlesh Silent Agony

    It looks so bad my face gets puffy and red, I get rashes on the other areas that it touches, the burning is also very bad on my hands. Needless to say I figured it out and do not use this ingredient anymore.