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Acne Cream with Salicylic Acid
Hi everyone. I’m a newbie in natural personal care industry and would like to know why my emulsion keep failed. I know there is so many salicylic acid post ald, but still hope you guys can help me check on my formulation also. Below are my formulation:
Water 67%
Sodium phytate 0.1%
Allantoin 0.5%
Glycerin 2%
Gum 0.5%Polyglyceryl-2-Stearate, Glcyeryl Stearate, stearyl alcohol 5%
Squalane 4%
Jojoba 4%
Heptyl Undecylenate 4%
Vit E 1%
Bisabolol 0.5%
Bakuchiol 1%Propanediol 2%
Salicylic acid 2%
Water 1%
NaOH 0.45%BG based mixture extract 4%
EO 0.5%
Preservative 1%After emulsify, I only add the salicylic acid, and I found that the visco of emulsion is drop after acid, extract and preservative. In RT, it’s stable but when I put into oven, the emulsion is separated. I have no idea on what’s happening, hope you guys can help me to check on this. Thank you
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33 Replies
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What gum and preservative are you using and what is the pH?
Dissolve Propanediol, salicylic acid and NaOH in water phase after adding sodium phytate.
What mixer are you using?
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Gum is mixture of acacia senegal gum and xanthan gum
Preservative is benzoic acid,sorbic acid. pH is 4.74
Did u mean I should add salicylic acid before emulsify? I have tried, but emulsion can’t formed if I did that way.
I use ultra-turrax homogenizer. -
Yes dissolve salicylic acid in water before emulsification.
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SA is oil soluble and I suggest using this advantage. Add it to your oil phase. I am not saying adding it to water is wrong but it’s more difficult to dissolve. Also, SA is irritating enough. Ditch bakuchiol and other unnecessary things. You are adding unnecessary variables.
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ngarayeva001 said:SA is oil soluble and I suggest using this advantage. Add it to your oil phase. I am not saying adding it to water is wrong but it’s more difficult to dissolve. Also, SA is irritating enough. Ditch bakuchiol and other unnecessary things. You are adding unnecessary variables.
He is converting it to sodium salicylate.
That oil phase of it can’t dissolve 2% salicylic acid anyway.
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I don’t put full stock in the HLB system, but your only emulsifers have a somewhat low HLB, you could try adding in something higher to balance out. Also 5% of both of those is likely overkill, try cutting them in half. Also, how long after finishing the mix do you wait before you put the sample in the oven?
Likely unrelated to your issue, but is your vitamin E the acetate form or tocopherol?
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evchem2 said:I don’t put full stock in the HLB system, but your only emulsifers have a somewhat low HLB, you could try adding in something higher to balance out. Also 5% of both of those is likely overkill, try cutting them in half. Also, how long after finishing the mix do you wait before you put the sample in the oven?
Likely unrelated to your issue, but is your vitamin E the acetate form or tocopherol?
Hi, the HLB of the emulsifier is between 8 to 10, still consider low?
After finishing the mix, I will wait for next day before put into oven. Vit E is tocopherol. -
2% Salicylic acid? This is an OTC product and not the best Formula for a self-professed newbie. Have you reviewed the Regs? Again, this would be an OTC Drug.
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Microformulation said:2% Salicylic acid? This is an OTC product and not the best Formula for a self-professed newbie. Have you reviewed the Regs? Again, this would be an OTC Drug.
Hi @@Microformulation Yes, I have reviewed the Regs. 2% is the max to use in skin care product
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2% would be OTC, not a Cosmetic. Again, try something else. An OTC can not be manufactured by a Cosmetic manufacturer. Trust me, I have dealt with this issue and the FDA’s stance with clients.
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On the other hand, if you aren’t going to manufacture and sell it, it doesn’t matter OTC or not. Having said that, you seriously need to rewrite this formula and this is the case where using pH strips isn’t an option at all.
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This one is ok. Try something like that. Ignore TEA%. The % of neutralizer depends on the desired ph and in this case it was low. -
Q: Propanediol 2%
Salicylic acid 2%
Water 1%
NaOH 0.45%Is this a separate phase where you try to dissolve the salicylic acid? I think @Abdullah may be right in suggesting dissolving the acid in larger amount of water. This is just an idea because I have never tried to dissolve it in such a small amount, but even in the larger amount it was quite difficult, the proportions in the other formulations suggested more water to prepare pre-solution.
What is the pH of this solution? It should be around 10. Do you add a solution with this pH directly to the cream? This can raise the ph above the allowable range for the emulsifier you are using. pH shifting can also destabilize the emulsion. If you lower the ph after adding the solution, do you do it by stirring? Lowering the pH below a certain level may cause salicylic acid to recrystallize. Your emulsifier is somewhat resistant to electrolytes, but the amount may be too high.
Generally, I think the salicylic acid may not be fully dissolved, I would try to make a pre-solution with more water, lower its pH before adding it to the cream. But this formulation seems very difficult, I would try it with an idea from @ngarayeva001@Microformulation, several popular brands have been selling products with 2% salicylic acid in the US for years, and their labeling does not imply that it is OTC, there is no mention of “acne” in any of them. It is not like in Europe that generally 2% is acceptable, but there is a rule that you cannot suggest a medicinal effect of a product? -
@Microformulation, several popular brands have been selling products with 2% salicylic acid in the US for years, and their labeling does not imply that it is OTC, there is no mention of “acne” in any of them. It is not like in Europe that generally 2% is acceptable, but there is a rule that you cannot suggest a medicinal effect of a product?I will let other Professional Chemists weigh in, but simply NOT mentioning acne but using an OTC active is NOT allowed. THIS IS NOT A LOOPHOLE.Again, a self-professed “newbie” (in the original post) should NOT be attempting an OTC product. Endorsing such is foolish.
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The use of any particular ingredient that is on an FDA OTC Monograph list takes into account not only the ingredient itself, but its intended use, so just because an ingredient is on an FDA OTC Monograph does not mean that any product containing that ingredient is automatically an OTC drug product.
Take Dimethicone for example. It is an FDA OTC Skin Protectant Monograph ingredient at 1% to 30%. Dimethicone is also commonly used in cosmetic products to enhance skin sensorials or to reduce soaping of emulsions. If the product is a moisturizer cream, it’s intended use is cosmetic, not as a skin protectant product and it makes no claims as a skin protectant. If it did make skin protectant claims, then it would be an OTC drug product.
Same with Salicylic Acid … it can be used simply as a cosmetic exfoliant. The intended use is exfoliation, not as an OTC ingredient for acne and no acne claims are made. However, a product can be considered both a cosmetic and an OTC drug product. Take Paula’s Choice 2% SA Exfoliating Solution … this product is sold as a cosmetic product and makes no OTC drug claims. You’re straddling a line where the FDA could declare your cosmetic product as also being an OTC, but if you do not make acne claims, then I have not seen any instance where the FDA had declared a cosmetic product with SA as an exoliant to also be an OTC drug product.
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I haven’t found a document that would fully explain this issue, but on the other hand, I haven’t found any indication in any document that the use of an ingredient that can be used in OTC automatically makes the product an OTC. Moreover, on the FDA website:
A product intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance is a cosmetic. If this product claims to accomplish these deeds through physiological activity or by changing the structure of the skin, it is also a drug. The product categories “drug” and “cosmetic” are not mutually exclusive. This is recognized in sec. 509 of the FD&C Act.
If a cosmetic is also a drug, the label must list first the established name of the drug ingredient(s) and the quantity, kind and proportion of any alcohol, in compliance with sec. 502(e) of the FD&C Act, as “Active Ingredients” and then the remaining ingredients, in compliance with § 701.3(a) or (f), as “Cosmetic Ingredients.”
https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide#clgl7
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The title to this thread is “Acne Cream With Salicylic Acid” … so the proposed formulation would be an OTC Drug product.
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I think this regulation from the FDA on intended use is relevant.
Basically, if your intention is to add SA for it’s anti-acne effect, even if you do not call out or advertise that effect your product is considered a drug by the FDA.
If your intention is to add SA for it’s exfoliation effect, you’ll have to be able to prove that’s why you added it. Calling your product an acne cream but saying the SA was added for some other reason seems a difficult claim to prove in my opinion.
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If you use the word “Acne” in describing your product, you are automatically under the FDA Acne Monograph and must use one of the 4 approved acne monograph ingredients within the allowed ranges or combinations. There is no wiggle room.
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Perry said:I think this regulation from the FDA on intended use is relevant.
This was the Regulation the FDA cited in a Warning Letter for a similar product. We were called in afterwards, but the FDA essentially felt that a 2% Sal Acid O/W Emulsion was “intended” as an OTC
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@grapefruit22 I would try it with an idea from @ngarayeva001
I didn’t edit the formula properly so would clarify just in case: it has separate water and oil phases and germaben goes to the cooldown phase. I added SA to oil phase (it can be heated). Try not to replace gelling agent unless you replace it to something electrolytes tolerant. You can replace preservatives and oils. Use pH meter or you risk getting irritation. 2% of SA might bring pH quite low.
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grapefruit22 said:Q: Propanediol 2%
Salicylic acid 2%
Water 1%
NaOH 0.45%Is this a separate phase where you try to dissolve the salicylic acid? I think @Abdullah may be right in suggesting dissolving the acid in larger amount of water. This is just an idea because I have never tried to dissolve it in such a small amount, but even in the larger amount it was quite difficult, the proportions in the other formulations suggested more water to prepare pre-solution.
What is the pH of this solution? It should be around 10. Do you add a solution with this pH directly to the cream? This can raise the ph above the allowable range for the emulsifier you are using. pH shifting can also destabilize the emulsion. If you lower the ph after adding the solution, do you do it by stirring? Lowering the pH below a certain level may cause salicylic acid to recrystallize. Your emulsifier is somewhat resistant to electrolytes, but the amount may be too high.
Generally, I think the salicylic acid may not be fully dissolved, I would try to make a pre-solution with more water, lower its pH before adding it to the cream. But this formulation seems very difficult, I would try it with an idea from @ngarayeva001@Microformulation, several popular brands have been selling products with 2% salicylic acid in the US for years, and their labeling does not imply that it is OTC, there is no mention of “acne” in any of them. It is not like in Europe that generally 2% is acceptable, but there is a rule that you cannot suggest a medicinal effect of a product?Based on your question, kindly refer to the below:
1. The pH of this premix is pH 4.5
2. Yes, I added directly to the cream by stirring
3. I didn’t lower the pH as the pH ald within the effective range of SABut I have another question is did you mention that my emulsifier is unable to resistant for the electrolytes as the amount of electrolyte is too high?
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They mentioned in the brochure that the emulsifier passed stability tests at elevated temperature in the presence of electrolytes without affecting the viscosity, but there is no information on what formulation was tested. They use acrylic thickeners in some other available formulations. Can you use Sepimax Zen?
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What preservative are you using … you only list preservative? Depending on the composition, the preservative may be the culprit in the reduction of viscosity.
(1) Add the SA directly to your oil phase. As mentioned by @ngarayeva001 it is oil soluble, so you don’t need the premix you are preparing. Note: why are you using both Sodium Phytate and NaOH … you only need one base to raise the pH. Unless you’re using Sodium Phytate as a chelating agent?
(2) Prepare the emulsion without the addition of the preservative. If the emulsion will not form or breaks, then you know that you need to choose a different emulsifier that works with SA. If the emulsion does form, but thins or breaks when you add the preservative, then you need to choose a different preservative.
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