Microformulation
Forum Replies Created
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My two cents is that much like many “Marketing trends” in many cases we place too much emphasis on what “might” be an issue and we are too willing to compromise on performance. In many cases we are placing far too much emphasis on what fringe markets may want.
That said, in the bulk of my experience, the Natural lines want ZnO or TiO2 vice Chemical sunscreens. Honestly, in the numerous calls I have had, nano has not come up at all in the last 24 months.
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Non-Nano ZnO >100nm with no whitening at 5-10%? Try Peter Pan Chemicals from Never Never Land.
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Behentromonium Methosulfate is derived from Rapeseed. It is allowed under many of the Natural standards.
Funny enough, even EWG gives it a “one”, nearly their lowest level of “toxicity.” I would avoid even using the term “toxic” as any ingredient (even one as innocuous as water) can show toxicity if the dose is high enough. Toxicity is a broad term and is generally more dependent upon dose than the material.
Lastly, just because it is “natural” doesn’t mean it is safer. Comply with a Natural standard but remember that “natural: is only one factor in being successful. You must meet a certain price point as determined by your market and it must perform.
Don’t try to make a “natural as can be” product at the detriment of price and performance. That is marketing, not formulating. -
Good lord, an EWG reference.
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It is a BASF product. Unless you are known to them and can show the possibility of a sale, good luck.
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That is extremely high! I am not sure of the background, but our testing lab uses >10cfu/ml as their threshold for a micro failure.
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1. Honestly, finding the 1% line requires a familiarity of the raw materials and typical usage rates. Sometimes, it is just an educated guess but usually it is pretty close.
2. I honestly don’t believe they use a preservative but it has been a bit. This is essentially a saponified product.
The best guidance I have ever found in making one of these products came from Harry’s Cosmeticology, Chapter 12 in the older versions. As I understand they have not included a great deal of sample Formulas in the newest edition.
I have knocked off “The Art of the Shave” perfectly in the past. If I recall correctly, you need to remember that it is a case where we get closer to a soap product than a Cream/Lotion. It is an exothermic reaction so you need to watch the heat. Lastly, in my experience the batches are very fragile when it comes to water loss and the need to account for the water loss.
Being an older product which many Cosmetic Chemists have successfully knocked off. I am sure that others can weigh-in.
Remember, the struggle is not generally in obtaining the Formula. It is cynical, but in my experience your level of success will be more tied into your Marketing than the product itself.
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Your PEG-12 Dimethicone is soluble in water and alcohols, unlike the remainder of your silicone phase. It should be added below 40C. Without manufacturing instructions I would have to guess that this is not a hot mix.
All in all, you may just have a process error.
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Yes, it is called an emulsion. If you are unfamiliar, you should not attempt this and hire a consultant. It is a very broad topics and a basic concept in Cosmetics.
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I added the document from the link you could not access to Google docs. It is here.
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Here is a Commercial Product with the raw material. Here is the datasheet.
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Never limit Ingredient usage at the risk of safety. It is quite easy for an experienced Formulator to identify what ingredients provide a benefit and what is in there for Marketing story. To even consider not using a preservative simply to “limit ingredient usage” is missing the big picture. Don’t let Marketing lead your Formulating as the primary factor.
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^^^Exactly what Belassi said. Cuts straight to the point.
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We generally adjust shampoos and Skincare products to 4.5 to 4.7 or so. Conditioners we do at about 5.5 to 6 or so. There are numerous reasons to support these pH values. However, pragmatically (in uncompromised adult skin) I really doubt that the slight pH differences would be all that significant.
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This is an introductory thread. If you have specific questions, start a new discussion.
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No offense to anyone, but in order to be more subjective I request unbiased proof. A logical fallacy is to lead with an untrue or proven fact, presenting it as fact and hence implying that it is an unassailable fact and then use this fact to support an argument. In all practicality the entire argument is built on sand and hence invalid. Unfortunately this logical fallacy is common in our Industry.
That said, perhaps in some way it is better. So I guess the challenge is to a. define objective, measurable and reproducible ways in which it is better. I see Bob’s point and I apologize if I misunderstood. My assumption is that you are asserting that a soap at a high pH is more effective than a surfactant cleanser at a pH of 4.7 or so.
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Under what objective standards can you say that a soap is a more effective cleanser at high pH? I agree that in intact, healthy skin the effects of the higher pH are negligible, but that doesn’t speak to efficacy, Could you cite a credible and documented Journal citation supporting that it is “more effective” and how?
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Also I would even be impressed to see how you would do anything, even make the soap base without using “any chemical substances.”
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Sunscreen oils are neither effective or approved. I have seen some of the fuzzy math used to support the “theoretical” SPF values. The logic is (and please I am spit balling these numbers) “Oil X has an SPF of 3.5, Oil Y has an SPF of 8 and Oil Z has an SPF of 6 so therefore my SPF is 17.5.” Well this is patently flawed as these are projected SPF for the oil at 100% concentration. At best you could project an SPF based upon the percentage used and SPF, similar to the method by which an overall HLB value is obtained from 2 or more emulsifiers.
That said, the above exercise is useless since SPF must be measured by a testing lab not extrapolated.
I guess the answer is you can flavor (did you mean fragrance since this is a topical, not oral dosage form) with anything since it is not a sunscreen either by performance or the legal definition. The oils are not approved under the FDA Sunscreen monograph.
Selling this product with SPF or even as a sunscreen would expose you to liability and scrutiny of the FDA.
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That really doesn’t fly and is more in the realm of paranoia.
The FDA has a great deal more oversight for OTC products and prescription products. Believe me, if you ever work in these sectors you will not believe for a moment that the FDA is protecting the Pharmaceutical Industry.
These actions are in fact coming about due to actions on the other end of the market, the home crafters starting their new lines and “natural” lines. There are numerous cases where these lines have over stepped the line with aggressive marketing claims. Just read the companies cited and their claims.
The line between drugs and Cosmetics is important since many of the OTC actives have a greater potential for adverse incidents. This law hearkens back to some of the abuses in our past, especially in the area of patent medicine. Nobody wants to go back to the days of “snake oil.” These regulations serve a purpose to hold us accountable.
Lastly, anyone who has ever interacted with the FDA directly (an audit for example) will agree that the FDA is not heinous and evil, but rather they have a true desire to get people to comply. In my experience at least, every FDA audit has been non confrontational and a learning experience.
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Many products are not shear resistant. For example, Carbomer will not react well to high shear mixing after it has been neutralized. In some cases you will need the lower end speed as well as the flexibility in mixing attachments that you would get with an overhead mixer.
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What is your final pH? I see you list TEA as I assume the neutralizer for the Carbomer but I don’t see an ingredient listed that would drop the pH back down to a more acceptable level.
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What is your emulsifier? Is it EWax by any chance?
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If you look at these Botanicals, I think you will see they are used more commonly for warts. I was not familiar with a moisturizing claim. It is very commonly produced as a homeopathic.
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All Academics aside, the proper answer is to discard the batch;
1. Should he add more preservative, there is a chance that he could be exceeding the Regulatory limits for that particular preservative.
2. This is inferring that the preservative possesses a disinfectant property, I am sure that a Micro expert can weigh-in, but I believe this is an erroneous assumption.
3. Lastly and most important. If you are properly documenting your batch records, you would have to document the out-of-standards results for micro. Should your last ditch remedy of simply retreating does not work (say it exceeds standards once it is with the consumer), the FDA would see that you violated good practices. Under credible cGMP standards, tossing the batch is the most conservative and safest approach.