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Amy limit to how much Retinol can be used?
Does anyone know if in the USA there is a limit set forth by the FDA as to how much retinol (not palmitate or any other form) can be used in a topical cosmetic (not OTC) skin product? Can a product contain 3%?
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17 Replies
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I don’t know of any limit except for use during pregnancy but 3% is very high and unnecessary .You are likely to get adverse reactions such as stinging/redness and doubt you would pass RIPT safety test.We have used it up to 0.3% which is borderline for sting etc, although I have seen it used up to 0.5-1%.
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Thanks DrBob, I appreciate your input
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If you’re just using retinol for marketing purposes, 0.2-0.5% is enough. If not, you can use it up to 1% only.
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Yes 3% it is the level of a retinol peel you will have severe side effects. I also think 0.25 is more than enough in a product for daily basis.
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You can’t use 1% retinol in formula. Is to much.
The SCCS has estimated that exposure to Vitamin A (retinol, retinyl palmitate, and retinyl acetate):
- via hand cream at the maximum concentration of 0.3% may lead to daily systemic
dose of 1661 IU for an adult. This exposure could constitute up to 33% of the UL of
5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in
hand cream products per se is safe.- via face cream at the maximum concentration of 0.3% may lead to daily systemic dose of 1185 IU for an adult. This exposure could constitute up to 24% of the UL of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in face cream products per se is safe.- via rinse-off products at the maximum concentration of 0.3% may lead to a daily systemic dose of 408 IU for an adult. This exposure could constitute up to 8.8% of the UL of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in rinse-off products per se is safe. -
The max I’ve seen on a leave on formula is 600.000 IU, more than that might be a prescription cream for specific purposes.
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Here is what the CIR has to say about Retinol (and Retinyl Palmitate). Basically, it’s safe to use <1%.
https://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/pr160.pdf
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@PerryCan you copy and paste what you found. I can’t see the article because I am not signed up with the.
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Sorry about that. You can try this link.
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Great, thank you Perry
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@Perry Good post as I was looking for it but couldn’t find it.
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Now I come to find out the customer wants 3% “retinol or retinoid complex”. Not straight retinol. Now the fun begins trying to find out exactly what retinoid or retinol complex means.
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Using clever marketing, “retinol complex” could be anything you want.
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In case anyone runs into the same thing I have found a product by Wacker called “Cavamax W-8 Retinol Complex”.
Some companies with a “complex” are actually using Retinol, retinyl palmitate, retinyl acetate combination. Others may be using a Retinol 10S at 3% but that’s not really “active” amount.
Skinmedica has a product they call “Retinol Complex 1.0” IS that the percentage or merely a part of the name? Ahh, have to love marketing.
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If your customer will accept 3 percent of retinol complex,Cavamax W 8 is 8 percent of active retinol in cyclodextrin. Sooo 3 percent of the complex provides 0.24 percent which is an effective level.We have used the product but did not do hydrolytic stability which is a concern but CD complex should help.
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Thanks DrBob. My customer did agree to use 3% of the complex itself. This is the best resolution as it greatly reduces the safety concern.
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It should be noted that some dermatologists and estheticians use 5-10% Retinol for peels, basically to get peeling effects and the effects or regular retinol use with less frequent applications. So depends who your customer is selling to.
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