Home Cosmetic Science Talk Formulating General FDA Urea limitations on cosmetic products???

  • FDA Urea limitations on cosmetic products???

    Posted by Graillotion on March 12, 2023 at 3:43 pm

    I was discussing urea in the context of cosmetics, and our memories led us to believe that possibly their was some regulations of the upper end of the Urea inclusion rate….for cosmetics.

    A cursory search…and I could not find this.

    Can anyone (in the context of USA) confirm or deny…if there is any cosmetic regulation to this effect?


    Still winter here….as well!

    • This discussion was modified 1 year, 1 month ago by  Graillotion.
    Unknown Member replied 1 year, 1 month ago 4 Members · 7 Replies
  • 7 Replies
  • PhilGeis

    March 13, 2023 at 6:14 am

    Urea is GRAS - re. foods https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1923

    “In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice.”

    Found nothing from FDA re cosmetic application. Here’s CIR https://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/PRS310.pdf. Looks likke they considered up to 10%.

    • Graillotion

      March 13, 2023 at 3:19 pm

      @PhilGeis ….as I am not a paid member…I could not open the bottom link.

      So….what I hear you saying is…. in cosmetics….there is no limit (legally) to how much Urea a product can contain? Correct?

  • PhilGeis

    March 13, 2023 at 3:37 pm

    Both links should be accessible - maybe I screwed up the cut and paste.

    The 1st was from FDA’s GRAS (Generally Recognized As Safe) notice for foods and it said there was no limitation - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1923

    The second was from CIR (Cosmetic Ingredient Review) and they concluded was safe as used in cosmetics but the max they saw used was 10% so that’s the limit of what they said was safe. They didn’t say greater was unsafe and talked about results for some exposures up to 60%. You can also find the info below on Google Scholar. Let me know if it still won’t open - I’ll down load andemail to you.


  • Pharma

    March 14, 2023 at 12:42 am

    GRAS doesn’t mean it’s even allowed in cosmetics… see choline chloride.

    Higher % can result in keratolysis. If the aim of your product isn’t of such nature, then you have your onw upper limit 😉 .

  • Unknown Member

    March 19, 2023 at 11:10 am

    Hello, it’s a simple OTC.

    Also available on Amazon – anyone can buy.

    • Graillotion

      March 19, 2023 at 3:34 pm

      I understand that. 🙂

      Just when formulated say at 40% by a novice…it becomes a bit more than a moisturizer. 😂

      I was wondering if there was any safety net in place.

  • Unknown Member

    March 20, 2023 at 11:05 pm

    Hi, 40% Urea is actually the standard concentration.

    There are no percentage regulations.

    Anyone can make it, buy it, sell it.

    It’s just a simple moisturizer/keratolytic.

    FD&C info:

    Zero rrequirements as to concentrations or cosmetic ingredients – except for listing lakes.

    I could literally pick pine needles off my pine trees, grind them into powder, call it a mask and market it. (and people do … 🤨)

    USDA FD&C regulations basically only deal with fair packaging and labeling aspects for consumers. Not the ingredients. Go figure.

    That’s it.

    Federal Food, Drug, and Cosmetic Act (FD&C Act)


    the Fair Packaging and Labeling Act (FPLA)

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