johnb
Forum Replies Created
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It is the responibility of the supplier (your US/CA manufacturer) to supply that information, or have I read this the wrong way round?
BTW, just because your products are 95-98% Naturally Derived does not, in itself, make tham harmless or exempt from governmental red tape.
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Jungbunzlauer
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but for concentrations of over 2% the cream can only be registered as drug and not as cosmetic cream.
The conditions you identify:
Hyperkeratosis dermatitis, follicular hyperkeratosis, ichthyosis,
psoriasis, acne etcare beyond the definition and capability of a cosmetic and any effective product should be classified as a drug.
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The gel was translucent (as stated previously) and contained microcrystals of salicylic acid. The acid was dissolved in the glycol (with heating) and the solution dumped quickly into cold water. There is more to it than stated there but the description gives an outline of the process.
I am becoming a little confused. Are you formulating a cosmetic moisturiser or a fully functional keratolytic?
The product I worked on was intended for the removal of warts and may not be applicable to what you seemingly want now.
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You are quite right that urea at 3% doesn’t do anything. I doubt that higher levels do anything real, either. The reason that urea was included in my formulation was that my client insisted that it should be present. The final product did not contain urea and the only reason I gave the urea formulation here is because you requested that I do so.
If you can get a suitable product without urea, I strongly encourage you to do so. If the main reason for the inclusion of urea is as a moisturiser rather than as a keratolyte then there are plenty of other materials which will fulfil that need (glycerine and propylene glycol even).
In the link you have given, the NaOH containing examples are not of any particular importance, i.e they do not figure anywhere in the Claims.
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I worked on this more than 20 years ago and so any information is from memory and may be somewhat hazy.
The product contained:Behenyl aclohol 5
Propylene glycol 15
Behenamidopropyl dimethylamine 4
Lactic acid 6
Salicylic acid 10
Urea 3
Water to 100There were a few more ingredient but not any that woul make any difference to the overall product.
I have no idea of the pH as any reading would be meaningless in the presence of so many interfering ions so it was not examined.
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OK, I accept that but it does not help with the current problem. Replacing all or part of the ozokerite and ceresin with a wax of the type I suggested is the first step to improving the syneresis that you are experiencing.
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The composition I worked on was more of a translucent gel rather than a cream. The propylene glycol was present to act as a solvent for the salicylic acid and as a humectant to prevent the gel drying out before it had chance to act. It also acted as a stabiliser for the whole product. There were no problems with consistency, possibly because it was not an emulsion in the commonly accepted meaning. My formulation also contained lactic acid as a salicylic acid stabiliser and as an auxiliary keratolyte.
I don’t understand why your composition should generate carbon dioxide. What are the ingredients?
I don’t understand either why you are neutralising the salicylic acid. It is the free acid that has the keratolytic properties, not its salts. From what we have been told, I think the whole concept needs reassessing.
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This is something I cannot tell you. There are so many variables that it requires of experimental work to optimise.
From where does the mixture originate? Is it your own recipe?
As a starter, reduce the amount of ozokerite and ceresin (why use both of these? they are very similar in constitution) and replace with HCO or one of the other materials I mentioned.
Beeswax is another material which may be useful as a stabiliser.
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I would keep to the original regime which met with the approval of the more rigorous inspector. Who knows but the next visit may be from this same person (or someone more finicky) who will tell you that your new system is not acceptable.
It seems that you will never get these officials to either agree amongst themselves or commit to anything of importance. They are in the business to enable them to take home a salary. Real knowledge of their job is usually sadly lacking.
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I am surprised that you find a “real” soap based shampoo acceptable. Do you have a very soft water supply that avoids scum precipitation?
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Hope you copied and pasted that list and did not laboriously type it out yourself.
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What is the purpose of this cream?
If it is as a keratolytic then it would most likely be better not to neutralise the acid with TEA.I worked on a urea/salicylic/lactic application for wart treatment and had no problems with stability. It contained 15% or so of propylene glycol and a fatty alcohol thickener.
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The list offered is more akin to a waterfree ointment than a cream and these quite often separate in the way you describe.
It may improve if you include a wax with better structure forming properties to replace part or all of the waxes you are already using. The materials I have in mind are carnauba wax, candelilla wax, hydrogenated castor oil (castor wax).
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I meant to say that I think what would work best is that you have a
system that includes (1) hair tonic, (2) shampoo, and (3) conditioner.
You could sell them together and separately. The main thing is that
it’s best to have the scalp/hair growth treatment to be a separate
product.I completely agree.
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manstra Please don’t think I was endorsing the use (or acceptablility) of DMDMH. I can see that my contorted use of English may have suggested that I was.
What I meant was that I would not use DMDMH (or any other formaldehyde derived/releasing product) nor would I use any thiazolone containing preservative under any circumstances.
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The biggest problem that amateur/hobbyist/artisan perfumers have is the lack of availability of a large number of (mainly) synthetic raw materials which are readily accessible to the professional perfumers employed by the established perfume houses.
The materials have many and varied attributes which cannot be imitated by essential oils and can have hundreds, perhaps thousands of times more powerful odours. These odours may not be pleasant per se but, under the expertise of a professional perfumer they contribute many important aspect to modern perfumes. As a rather old example of this, dodecanal - the odour of which can be described as unpleasant or even very unpleasant when smelled alone is the characterising note used of Chanel No 5. The use of dodecanal dates back to 1923 and Chanel No 5 is still one of the most popular perfumes available. It doesn’t take much imagination to appreciate the advances made in synthetic chemistry since then and the influence that has had on perfumery.
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I don’t know where you are located but, in most countries, any product claiming to be a sunscreen must have been tested to prove that it is a sunscreen and offer a numerical indication of the effectiveness.
To save yourself a lot of marketing and regulatory problems, I suggest that you forget about including a sunscreen material.
To help stabilise carbomer against UV degradation, one of the easiest ways is to use a chelating agent e.g a gluconate or EDTA.
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I would tend towards working on either a hair conditioner OR a scalp product and not try to combine the two. They are, after all, intended for different parts of the body (albeit in close proximity) for different purposes.
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Olive oil derived squalene/ane is a marketed product and far from being a mysterious “unsaponifiable”. Available from eBay and Amazon (and many other places) quite easily.
You might like this https://www.ncbi.nlm.nih.gov/pubmed/10908812
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Why are you including a sunscreen in this?
There is most likely insufficient present for the product to marketed as an effective sunscreen and if it is there to stabilise the carbomer against UV degradation, then other materials can perform this function.
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I agree.
I have not, nor ever would I, use DMDMH or thiazolones in anything at all - not even drain cleaner.
The sensitising potential of Kathon (thiazolone) preservatives was known at the time of their introduction in the late 1970’s early 80’s. Rohm & Haas who introduced the products brought them on to the market seemingly in the hope that their very small in-use concentration would allay any fears of adverse effects.
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There is a lot more to making a lipstick than melting the ingredients together and pouring into a mould - just as there is with melting a pre-made base and adding colourants/pigments.
The ingredients list you have given does not correspond to any
lipstick that I have come across. Where was it from?Lipstick colours require to be very finely dispersed by milling (or a similar process). This is not easily achieved by hand mixing.
I recommend that you find out exactly what procedures are involved before even contemplating actually making a product. For example, bentonite clay requires a very specific dispersing procedure before it can perform any useful function. Most bentonite clays used in cosmetics are modified and predispersed to some extent (e.g as Bentone Gels). The same effect cannot be achieved by any procedure you appear to be using.
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A lactate buffer can help stabilise urea in solution but it is difficult to make an informed recommendation without knowing the identity of this other active ingredient and the other components of the cream.
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Rereading the above I notice part of a sentence has been lost somewhere. What it should read is:
The term “saponifiable” should only be applied to materials capable of
forming a soap and glycerol when hydrolysed by appropriate treatment with an alkali.
This being so, the only materials capable of saponification are fats (
which are defined as the fatty acid esters of glycerol). Naturally
occurring fats are seldom 100% glyceride and contain minor amounts of
other materials which may not be reactive under the conditions imposed
by the saponification process - these are the unsaponifiables.