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How would you formulate a salicylic acid moisturizer for acne prone skin? Proposal within
Here’s a simple emulsion that could work, but the resulting low ~pH 3 could potentially destabilize the emulsion and cause curdling. Looking to make a formula that’s nourishing and relatively gentle used as an everyday moisturizer (if making claims about treating acne it would be a OTC drug limited to 2.5% salicylic acid).
Could a silicone based and/or water based formula work better and still work well as a moisturizer? Do you know any good formulas already on the market? Paula’s choice 4% SA formula seems to be quite popular.Water 64%
Sunflower Seed Oil (High linoleic) 10%
Propylene Glycol 8% (SA solubilizer)
Emulsifying Wax NF 6%
Lactic Acid 3%
Sodium Lactate 3%
Glycerin 3%
Salicylic Acid 2%
Phenoxyethanol, Caprylyl Glycol, Sorbic Acid (Optiphen Plus) 1%
Xanthan Gum 0.5% -
21 Replies
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I thought highest you can go with SA is 2 %?
How are you going to solubilize SA?
Doesn’t matter what base you use. make sure you don’t form any crystals for SA -
What is the point behind not using an emulsifing system?
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@Bobz:
The answer should be self-evident. -
It does have an emulsifier, the NF wax.
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Belassi, I still don’t think there’s enough Polysorbate 80 in the ewax to act as an emulsifier for any more than a 1:1 ratio with an emollient, at best.
And Mark, I think that there are better ways to do this. -
@Bobz
I was being facetious … Highly likely the formula simply will not work … for reasons that are self evident from looking at the proposed formulation -
Yes Bob, taking another look there is too much sunflower oil for it to work.
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Formula works just fine, rock stable over 6 months at 45C. In fact It’ll work with twice the amount of oil.
I was more so wondering what changes would make it more effective as an acne treatment.
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Hello, I do have such a formulation that I think would solve your problems, however I do not work for free. If you would like to receive a sample to try out let me have your address and I will send you one. However if you like it you will have to buy the formulation from me. Best regards edwardgaunt@gmail.com
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@ytzme - Is your formula FDA/Health Canada OK?
Also, where are you based and can you manufacture yourself or just do the formula? -
Zink is asking for opinions on what may make his existing formulation more effective and you offer to sell him a formula, hmmmmm. My opinion is if someone asks for help and you don’t want to help then don’t. Zink does his own formulating from what I have read and like many of us comes here to help others and also seeking help sometimes. Amongst other things this forum is a resource for all of us who need help sometimes.
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I intended this as a kind of open ended discussion about what type of formulation would be the most effective as a base for salicylic acid - e.g. an emulsion like I proposed, or perhaps a water or silicone based formula.
Ideally there’d be studies comparing its efficacy vs acne in different types of vehicles, but I’m not aware of any looking at that.
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DavidW thanks very much for your opinion. best regards edward
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What’s the possibility of this formula being too greasy? I experimented with a similar idea ,however, felt my face was too shiny and oily.
Could adding a silicone make it more dry-feeling?
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Hello all,
I am very confused from the fact that salicylic acid is considered as an OTC drug from the FDA.
In this monograph I see Salicylic Acid over 2 up to 5%http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM135691.pdf
Does it mean that if I use for instance 1.5% SA, my product is not considered an OTC drug by FDA?
How can I legally use SA in a cosmetic, for instance face cream, without it being considered OTC drug?Thank you!
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It all depends on what function the salicylic acid is performing in your product and at what level you have incorporated the salicylic acid. Salicylic Acid is an OTC acne drug and can also be used in OTC wart treatment products, albeit it a much higher levels than in OTC acne products (0.5% to 2.0%) per the Acne OTC Monograph: (www.fda.gov/downloads/Drugs/…/Guidances/UCM259744.pdf).
Salicylic Acid can also be includes as a component of a cosmetic preservative and/or as an exfoliant. It all depends on if you are making claims as an acne treatment or wart treatment product or not. If you are not making any drug claims, then it is a cosmetic ingredient.In some instances, a product can be considered both a cosmetic and a drug. So, unless you’re using Salicylic Acid as part of a preservative, depending on your product end use, inclusion of SA could land you in OTC drug status as opposed to cosmetic status, or both. -
As it relates to Salicylic Acid at level over 2% and up to 5% relative to acne OTC treatments, this is what they are referring to:
Sec. 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. (a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses:
(1) Topical acne drug products.
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One of the areas that has gotten chemists and companies in trouble is the use of drug ingredients without making drug claims, thinking that this will keep them out of the drug category. This is NOT true. From the FDA’s website: http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm
” The FD&C Act defines drugs, in part, by their intended use…How is a product’s intended use established?Intended use may be established in a number of ways. The following are some examples:1)Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials…2) Consumer perception, which may be established through the product’s reputation. This means asking why the consumer is buying it and what the consumer expects it to do.3) Ingredients that cause a product to be considered a drug because they have a well- known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.”So, this means that the FDA can declare your product to be a drug, regardless of ANYTHING you do or do not claim, if either enough people think your product is a drug, OR, if your product has a well-known drug ingredient in it.Sal Acid is a special case, because the FDA doubts that it works. But still, be very careful. -
Mark and Bob thank you!
I was thinking of using Sal Acid around 1.5% not specifically against acne, but as a “purifying” ingredient, as it is supposed to act on the sebum in pores.But I guess then it would be better to use white willow extract, to not get in trouble with FDA?Thanks! -
Salicylic Acid is sebum-soluble. What is actually does is form a “coating” so the dead skin cells that normally she do not form a sticky plug when mixed with sebum that clogs the hair follicles.Yes, you would be better off using a natural source of salicylates as opposed to SA directly.
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Clear, thank you!
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