PhilGeis
Forum Replies Created
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what product?
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FDA does not “approve” specific sunscreens. They are made in compliance to the relevant monograph, drug GMPs, etc.
https://www.accessdata.fda.gov/drugsatfda_docs/omuf/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse09242021.pdf -
Prob best to examine mineral sunscreen labels of major manufacturers.
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Glycols at higher conc’s can irritate. It is often transient, disappearing with continued product use as iwith relevant deodorants,
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What is surfactant?
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Agree with Paprik - water activity with making controls would prob work for self life tho 70% sucrose would leave potential fungal gap. - if preserved, suggest you shoot for that target. FA releasers and phenoxy not so useful in that context. what’s pH?
With packaging - what is expectation of consumer water addition/contamination/ -
Glycerine from Sapogel + 2% is prob irrelevant - great if you could get Aw data but I know that’s not generally available.
What’s powder bioburden?
Hot fill ? Does it appears to take up water? -
The quality of their product is not the quality of your product. Can you share your risk assessment?
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MurtazaHakim said:4% w/v of CHG is the active ingredient. A formulation with such a high % of CHG should not require any other preservative.
Wrong. Or perhaps you can prove it.
To note in your “proof” - https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/outbreak-of-burkholderia-cepacia-bacteremia-caused-by-contaminated-chlorhexidine-in-a-hemodialysis-unit/85154B587466D8DD5BFC9F9971CDF95E
https://academic.oup.com/jimb/article/42/6/905/5995474?login=true
and many other such reports in google scholar.
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Not only will phenoxyethanol not cover fungi and Gram positive bacteria well enough - if diluted 1:10 as you indicate, you’ll have only 600 ppm - and inadequate level in any case.
Will you have the consumer dilute?
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what is the preservative?
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CHG is a poor preservative.
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Not “purpose”. Those are not added.
Na Carbonate is a natural contaminant of NaOH - a product of CO2 from air and NaOH.
NaCl is a feedstock for NaOH production - prob left over from that process. -
2500/2000/1000 ppm respectively with EDTA
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Yes.
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Please understand - it is impossible to assure a complete absence of reaction to any consumer exposed. Big companies develop products designed and tested globally to sell millions of units for years to diverse consumers around the world. Potential reactions are followed through consumer comments, reports of dermatologists, etc.
Retailers? Many have gone woke and chemophobic and big companies are conflicted. Big company managements are as woke as retailers’, but their technical folks know BS when they’re asked to put it in products.
Example - preservatives, managements of the big guys got together and funded a greenie org. 3G to search for alternatives. 3G claimed great success (see: https://www.sciencedirect.com/science/article/abs/pii/S2352554120305696). What is not reported - they found nothing of substance. But note the BS, typical of parasitic org.sI appreciate the dilemma folks here face. It’s one thing to parse “natural” but a much more significant to let that constrain preservation. Just passing USP 51 is very poor to no assurance and you should not sleep at night with e.g. natural eye of new to a few organic acids unless you have great control and monitoring over manuf. quality and barrier packaging. You’ll likely never hear of the “harmful” effects - but those are reality.
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Be sure to check the clumps dissected.
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What packaging has your product vulnerable?
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Prob not - but check micro for mold.
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I’ve a lot against the BS marketing. Puffery to snake oil to fear mongering - I know the crappy preservative systems put consumers at risk.
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Amen, Perry
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Trust me - THIS time I’m not adulterated.
I’d be cautious. An ingredient adulterated in any context is impeached until proven otherwise. Better be confident in origin, process and analytical data that. -
yes
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and it is not “bad”
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CMIT aq solubility is much greater than those - I’d not worry