Home Cosmetic Science Talk Formulating How would you formulate a salicylic acid moisturizer for acne prone skin? Proposal within

  • How would you formulate a salicylic acid moisturizer for acne prone skin? Proposal within

    Posted by Zink on June 5, 2015 at 1:56 am

    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%

    AnnalisaB replied 8 years, 4 months ago 10 Members · 21 Replies
  • 21 Replies
  • cherri

    Member
    June 24, 2015 at 5:15 pm

    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

  • Bobzchemist

    Member
    June 24, 2015 at 9:34 pm

    What is the point behind not using an emulsifing system?

  • MarkBroussard

    Member
    June 24, 2015 at 10:39 pm

    @Bobz:

    The answer should be self-evident.
  • belassi

    Member
    June 25, 2015 at 12:16 am

    It does have an emulsifier, the NF wax.

  • Bobzchemist

    Member
    June 25, 2015 at 2:08 am

    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.
  • MarkBroussard

    Member
    June 25, 2015 at 12:15 pm

    @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
  • belassi

    Member
    June 25, 2015 at 4:44 pm

    Yes Bob, taking another look there is too much sunflower oil for it to work.

  • Zink

    Member
    June 25, 2015 at 5:15 pm

    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.

  • ytzme

    Member
    July 9, 2015 at 9:27 am

    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

  • AuroraBorealis

    Member
    July 9, 2015 at 1:36 pm

    @ytzme - Is your formula FDA/Health Canada OK? 

    Also, where are you based and can you manufacture yourself or just do the formula?  
  • DavidW

    Member
    July 9, 2015 at 7:15 pm

    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. 

  • Zink

    Member
    July 9, 2015 at 11:37 pm

    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.

  • ytzme

    Member
    July 10, 2015 at 4:35 pm

    DavidW thanks very much for your opinion.  best regards edward

  • georgiliolev

    Member
    January 17, 2016 at 9:30 pm

    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?

  • AnnalisaB

    Member
    January 25, 2016 at 5:31 am

    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!

  • MarkBroussard

    Member
    January 25, 2016 at 6:08 am

    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.
  • MarkBroussard

    Member
    January 25, 2016 at 6:12 am

    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.

  • Bobzchemist

    Member
    January 25, 2016 at 3:29 pm

    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.

  • AnnalisaB

    Member
    January 27, 2016 at 6:26 pm

    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!
  • MarkBroussard

    Member
    January 27, 2016 at 9:53 pm

    @AnnalisaB:

    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.
  • AnnalisaB

    Member
    January 28, 2016 at 2:02 am

    @MarkBroussard

    Clear, thank you!

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