MarkBroussard
Forum Replies Created
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Here’s the FDA OTC Monograph for Acne products:
If the product does not contain one of the FDA approved ingredients you cannot use the word Acne in your marketing
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Yes, I don’t think the % of revenues model is working for anyone. Not sure if EWG is still pursuing that as a model any longer.
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I am currently working on a project to create a vegan mucin. It is comprised of as many individual components of snail mucin as possible, plus some other ingredients, but flaxseed extract is not something I tried. I see that Lucas Meyer has an ingredient, Scuptessence, that is a flaxseed extract. You might give that a tried.
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By custom mucin I assume you are referring to a Snail Mucin? If so, you can purchase freeze-dried snail mucin and use that as a base.
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Still working on the Certification, but yes there will likely be a fee
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As @PhilGeis pointed out, you are probably Small Business Exempt. Your situation is exactly why FDA created the Small Business Exemption … they did not want to have a registry of home-based businesses in FDA Direct, but they could have created a separate SBE Directory.
You are subject to all other mandates of MoCRA even if SBE. Your products must have Safety Substantiation dossiers - Preservative Challenge Test Results (Passing) + Cosmetic Ingredient Safety Reports (essentially a toxicology profile of each ingredient in your formula). You do not need to conduct Skin Patch Testing if you have a robust CISR. You also must comply with Serious Adverse Event/Adverse Event Reporting & Recordkeeping.
Reach out to me if you need help with MoCRA compliance.
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The issue you are going to have with SugaNate 160 if you use it solo is that it really does not create much foam relative to SugaDet Mild. @camel gave you some good advice on other surfactants that you can add to SugaNate 160 to create a gentle blend.
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These ingredients have been developed by some of the leading cosmetics companies including Givaudan, Lucas Meyer Cosmetics, Solabia Group (all based in the EU). I think they have the regulatory and technical/safety aspects covered.
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I forgot to mention that Solabia’s Serenibiome just won the Most Innovative Raw Material award at the recent Society of Cosmetic Chemists Supplier’s Day. So, yes, neurocosmetics can be a path forward toward innovation in the cosmetics industry.
Agree that it is difficult for consumers to sense minor differences in the appearance of their skin from use of cosmetic products, but they are looking at it with the naked eye and no scientific training. That is compounded by marketing that creates unrealistic expectations on product performance. The issue here is the marketing may lead neurocosmetics down the path of CBD with the product expectations being so overhyped that the products cannot possibly deliver the “promised” results, nor were they ever intended to.
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Hello Nils:
Are you aware that in the US SPF products are regulated as Over The Counter Drug products? It costs approximately $75,000 to get all the development and testing done to bring an SPF product to market. Best you start with a cosmetic Moisturizer.
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Couple of issues:
(1) Higher molecular weight HA and Xanthan Gum are generally incompatible. If you want to use Xanthan Gum, you’ll need to incorporate an HA less than 50kDA that won’t gel.
(2) Allantoin: Incorporate it in water heated to 50-55 C. It will go right into solution. If you use more than 0.5% Allantoin and/or incorporate at temperatures greater than 55C, the Allantoin will precipitate out of solution.
(3). Increase your solvent for the HA to 35%. You can cut back on the amount of Sodium Citrate to a 1:10 ratio of SC:SA. Heat the solvent to 70C or so and then add the SA.
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This reply was modified 3 weeks ago by MarkBroussard.
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This reply was modified 3 weeks ago by
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Yes, two issues with your approach. If you are using a Hyaluronic Acid greater than 50 kDa, it will gel. Two, if you add the HA prior to emulsification, the homogenization is shreding the HA chains. You will first need to form the emulsion w/o adding any HA, and then add the pre-hydrated HA post-emulsification. Higher molecular weights of HA can interfere with the formation of the emulsion if added pre-emulsification.
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Yes, it is safe to use HA Serum with Microneedling. Several Microneedling devices are designed to coat the needles with a serum during the microneedling session. I have developed serums for these devices and no reports of any issues.
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The way I usually do this is measure 1 gram of Citric Acid in a container. I then add Citric Acid a small amount at a time while measuring the pH. When I hit the desired pH, I then measure the remaining Citric Acid and I then know how much I added.
With liquid pH adjusters such as Lactic Acid you can do the same thing. Measure a known amount of the pH adjuster and then measure the amount not added to derive at how much you added.
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Absolutely, there are often ingredients and/or product formats that clients do not request. I often create formulas for my own benefit so I can experiment with a wider variety of ingredients and delivery systems. Best way to learn, imho.
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Tocopheryl Acetate is virtually worthless in cosmetic formulas. Stick with Tocopherol or Tocotrienols. You can use 0.2%, but I’ve seen it used at up to 2%.
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Then why not use Sodium Benzoate + Potassium Sorbate?
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Are you using unpreserved Hydrosols?
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It’s really straighforward: In water, dissolve 5% Tranexamic Acid, 4% Niacinamide, 2% Alpha Arbutin + 0.6% Phenoxyethanol (and) Ethylhexylglycerin + 1% Gluconolactone (and) Sodium Benzoate. You will get a pH drift from the Gluconolactone over the first few days, but that should level off to a stable reading. If you want to add some “body” to it, you can thicken it up with 0.2% Xanthan Gum, otherwise it will be water-thin like a toner.
I don’t know what the final pH of this concoction would be so you will have to measure it when you make your first batch and adjust if necessary. If the pH is too low (< pH 3.5) you can adjust it upward by adding in QS (Quantity Sufficient) L-Arginine to get it to pH 4.5 or so.
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These are all water-soluble so you simple add them to water, add some preservatives and perhaps a buffer. This is a take off of Skinceutical’s Discoloration Defense. Is that what you are using as a development model?
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That’s because the Certified Organic regulations were developed for food products, not cosmetics. NSF has established a certification NSF 305 to address cosmetic products, but it is not as prominent a certification as the USDA.
There are two levels - Certified Organic must contain at least 95% organic certified ingredients. Made With Organic must contain at least 70% organic certified ingredients.
To get an Organic Certification, the Contract Manufacturer must be certified to manufacture organic products and you must use organic certified ingredients as mentioned above.
For a CM can get certified to manufacture Organic products, it must go through the process that is administered by an Organic Certification Authority such as Oregon Tithe. The first step for a CM is to get in touch with a Certification Authority who will guide them through the requirements, conduct the inspections and issue to certificate. There are certification authorities in most every state in the US.
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Yes, CM’s must be Organic Certified to be able to manufacture Organic Certified products. CM’s who are not Organic Certified cannot manufacure Organic Certified products.
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No, sorry I don’t have a source of irradiated clays. I try to avoid making clay products … too messy.
Yes, Pentylene Glycol can boost preservatives.
I’ve never used Lincolcide K … that’s poison to my clients.
If you start with irradiated clay it makes you job much more simple. You need to have the preservatives well dispersed in the water phase prior to the addition of the clays. Otherwise water containing no preservative will fill the interstitial spaces of the clay and that’s where your contamination will start.
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Couple of recommendations. As @PhilGeis mentioned, start with irradiated clay. Second, add your PE9010 to the water phase and disperse well before adding the clays. PE9010 alone is not going to be sufficient to preserve a clay-based formula. Add-in Gluconolactone (and) Sodium Benzoate and perhaps some Pentylene Glycol and get your pH down to 4.5 or lower.
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Simple rule: Always own the IP to your formulas unless you are going to private label. Owning the IP is much cheaper to negotiate upfront then after you have a successful product on your hands and you want to sell your business. Also, if you don’t own the IP and the business relationship with your CM has gone sideways, you either have to negotiate a buy-out with a partner who may not be willing to sell the IP to you or you’re stuck having to reverse engineer and start all over again.
