[mhart123]

I have tried the Acrylates / C10-30 alkyl acrylate crosspolymer.  It works well and we have a large amount in stock here but I was hoping to use something with Carbomer as the INCI, but if worse comes to worse I will stick with the acrylates.  I did come across a lot of carbomer variations from 3V, so hoping maybe one of those will work out. 

[mhart123]

@ketchito the menthol will solubilize in the methyl salicylate but I thought maybe the propylene glycol would help it mix into the emulsion better.   I did make a batch with the propylene glycol in the water phase but ran into the same issue. 

For whatever reason, I thought menthol would have to be added below 50C but I think I got the melt point temp confused with the flash point temp.  Just checked that the flash point is 90C so I guess I could add both in the oil phase?

[mhart123]

Coming back to this discussion to see if anyone has some insight..

Formula is listed below, it emulsifies but is water thin and pH is 8.6. The competitor product is 6.5 and viscosity of 20,000cps. The emulsion gets super thick after phase B is added to A and it cools but as soon as C is added it thins out and has no viscosity.  Any thoughts on how to increase the viscosity?

A
	Water	50.40
	Methylparaben	0.200
	TEA	0.30
B	Stearic Acid	7.00
	Lanolin	2.00
	Glyceryl Stearate	5.00
	Propylparaben	0.10
C	Propylene Glycol Methyl Salicylate	10.00 15.00
	Menthol	10.00
D	Citric Acid	0.00

[mhart123]

Thanks @Dr_Sara for the article, a lot of good information in there!

@ketchito I had a feeling it was probably the shea butter, I will make a new batch with your recommendations today and see if that will help prevent the crystallization in the future.

@Pharma I’ve done a quick cool down with the balm I made in a jar but never really thought about it for the stick since it cools down pretty quick on its own.  I will test this out as well.

[mhart123]

Looks more like crystals than branched threads, its so hard to tell though I feel like I’m going cross-eyed trying to look at it. I don’t love the formula, although it feels decent on the skin, but being all organic there’s not to many options to be creative..

[mhart123]

@Dr_Sara This is what it looks like, it was hard to get a clear picture, but I will test out some other waxes to see if it improves, thank you!

[mhart123]

@Bill_Toge this is what is listed on the TDS. I can just assume that the limits are low enough then so we won’t need to worry about calculating any safe harbor levels or including a prop 65 statement? (this is a face balm in stick format, so I would say they probably wouldn’t be using more than 1 g of product per day, coconut oil is at 20%)

[mhart123]

@EVchem  I found the same document, the one below is longer but has the same information.  So to me that sounds like no, it would not need to include a warning. However, the supplier of the essential oil (Prinova) said we must have a warning on the label because it is a consumer good. We are using it at 0.45% in the formula so it will be diluted but I would just like to have a for sure answer.

http://www.ahpa.org/Portals/0/PDFs/Member-Only/Prop_65_Herbal_Products.pdf 

[mhart123]

@Bill_Toge that’s a lot more straightforward than I thought.. thank you!! 

do you know about naturally occuring substances, do those require a prop 65 warning? for ex, eucalyptus essential oil contains myrcene and the coconut oil I am using contains aresenic, mercury, lead, cadmium, and nickel all at  <0.1 ppm as a natural impurity.  I see conflicting answers everywhere regarding if it will need to contain a warning, specifically for the myrcene (which doesn’t have a safe harbor level).

[mhart123]

One more question, instead of going through the organic certification process for the finished product, are we able to identify the organic ingredients on the info panel even if we are using 100% organic ingredients?

From NOP - “Less than 70 percent organic ingredients-
-Products cannot use the term “organic”
anywhere on the principal display panel.
However, they may identify the specific
ingredients that are USDA-certified as
being organically produced on the
ingredients statement on the information
panel. Products may not display the
USDA Organic Seal and may not display
a certifying agent’s name and address.
(Water and salt are also excluded here.)”

[mhart123]

There is Plantasens VL by Clariant and SMA has a vegetable alternative to lanolin as well.  I think they are both a little more sticky but it might be worth a try

[mhart123]

https://www.uline.com/BL_2896/Screw-Top-Metal-Tins?keywords=metal+tins

maybe something like this would work?

[mhart123]

@chemicalmatt they had made the batch on a Thursday but waited until Monday to fill it.  I was told they had only reheated to ~35-40C and it was transferred using a diaphragm pump. Chances are it could have heated way past 40C.  But I took some leftover product from the stability batch, heated to 60C with pretty high shear and then cooled and it did not show any separation, although that was only about 500 g. 

Formula:

Phase A : Deionized Water, Magnesium Sulfate, Glycerin, Aloe Vera,
Euxyl PE 9010, Potassium Hydroxide 

Phase B: Mineral Oil, Microcrystalline Wax, Sorbitan Sesquioleate, White
Beeswax, White Petrolatum, Vitamin E Acetate, Dimethicone

Phase C: Zinc Oxide 

Would it be better to add zinc into the oil phase then add water, instead of adding after the two phases are combined? 

[mhart123]

Thanks @Pharma, I did some searching on here through older posts and found that the trolamine would I guess kind of activate the stearic acid and help with the emulsification.

I mixed trolamine into the water (pH was 8.5) before adding the oil to the water phase and the emulsion turned out better then my previous tries, however it was still pretty thin.  Then with the addition of citric acid the oil separated out (pH 6.9). I will check to see what the pH of the competitor sample is when I receive it, but are there pH limitations for the stearic acid/trolamine combo?

[mhart123]

@letsalcido for otc labeling, the inactive ingredients can be listed in alphabetical order so that makes it a little trickier when trying to determine use level. I do not have a sample of the product yet but when I get it, I will try that out.  

[mhart123]

That is water 

[mhart123]

Someone had mentioned that benzalkonium chloride and betaine react together to form benzoic acid and maybe thats falling out of solution, but I can’t find any information supporting that, thoughts?

[mhart123]

It is the babyganics foaming hand sanitizer.

INCI: Benzalkonium Chloride (0.1%), Inactive: Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid, Medium Chain Triglycerides, Triethyl Citrate, Citrus Reticulata (Mandarin Orange) Peel Oil, Tocopherol, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil

[mhart123]

@lmosca we tested competitor product that contained 0.1% BZK to see if maybe it was an error with our method and that tested at 0.098 and 0.088% BZK.  The past few batches I have made we’ve added 20% more bzk and they are now testing out in spec but it is not making any sense. 

@DRBOB@VERDIENT.BIZ I will try that out, thanks!

[mhart123]

@ozgirl yes the raw material solution is testing at 0.55% BZK so you would think that our finished product would be testing at a higher level of BZK.  I’ve tried to get in contact with our supplier but no response yet, but I’ve been using an older lot of BZK that we have had since 2018.

[mhart123]

Visually we do not see anything precipitating out. But something is causing it to not test at the correct level. The last few batches we have tested have come out at 0.10% BZK when it should be 0.13% BZK.

[mhart123]

You need to better solubilize the menthol.  Try adding 20% propylene glycol to your alcohol phase and that should help give you a nice smooth, clear gel.

[mhart123]

Not sure if you still needed help on this but cutting down on water and add a lot of propylene glycol/glycerin will give you a nice clear gel.  I use 20% propylene and 30% ipa for a 6% menthol gel

[mhart123]

@Pharma Thank you!!

@ngarayeva001 good to know, thanks! I am using euxyl PE 9010.  The phases are being combined at 70-75C, will the preservative hold its efficacy at that temperature?  

[mhart123]

Like I said, I am new to this company and I do not have any experience formulating drug products.. only cosmetics.  It was a request from a customer to put it in at 20%, for itch relief, and they have been making the product for years now.  I believe it is their processing that is causing issues when they scale it up.  They premix it in propylene glycol and then add it to the emulsion around room temperature, however it turns out super gritty.  

The melt point for benzocaine is around 90C so that is probably problem #1.  Second, I’m not sure if propylene glycol is the best choice to solubilize it. I am going to try out Peg-8 and Peg-75 as another option as well as maybe moving away from a cream base and making an oil-based product like you suggested.