[Zink]

Hi Problemod89.

It’s verbatim from the Amazon requirements, so it’s not or at least was not inaccurate when I posted it. 

Also you might be approved, but then be hit with these requirements.

[Zink]

Thanks Matt, this would work, but in my case I believe it needs to be from a third party.

I’ve found that UL will do this, where they send inspectors over at a day rate of around $2500 and it takes 2-3 days every year.

[Zink]

@sabahi how did you do with approval?

@Bobzchemist ICMAD GMP certificates are not valid, they need to reference a US or international GMP standard.

A COA or FDA registration in the voluntary cosmetics registry might work.

[Zink]

Their MOQ is 10000 units, not super low! (Stated on the website)

[Zink]

It seems you can get a certificate through ICMAD in which list your manufacturer (“the company who does the filling”).

Then you MIGHT be able to register as the combined manufacturer/distributor on Amazon, letting you use your own company name instead of revealing your 3rd party contract manufacturer to the public.

One major caveat is that this would require both you and your manufacturer to become members, at least $500 for you, and for your manufacturer it could be several thousand depending on their sales.

[Zink]

So, could you get a GMP certificate without actually manufacturing anything? In that case you could register as the manufacturer even if you use a CMO.

Alternatively a FDA cosmetics or OTC registration could suffice. Maybe something to try first if you don’t want to list your CMO on the packaging.

[Zink]

@Bobzchemist they require 3rd party certificates. I believe the specifics vary from state to state on how you get em. Not something I know a lot about, and I’m not sure Amazon does either.

[Zink]

The exact requirements seems to be changing on a weekly basis, they may not have been required to pay a fee.

Yes MSDSs are also commonly requested if your product contains any volatile ingredient such as alcohol, I believe this is automatically searched for by some algorithm. 

One thing I will say, the proficiency of evaluating these documents by Amazon seem quite variable; beyond having a the key elements they ask for there doesn’t seem to be any clear standards out there.

[Zink]

@microformulation I’m not quite sure who you are replying to, I was asking Perry how he’d get a cGMP compliance letter if he’d states he’s the manufacturer without actually being the manufacturer..

For me this change will likely give me an advantage, the issue I raised in my post was having to disclose your CMO on the packaging, which I think is odd as it’s beyond what the FDA specifies. Personally I don’t have a problem with it as I like transparency, but it would mean having to reprint a lot of packaging to confirm with Amazon’s standard.

[Zink]

If you’re not actually manufacturing the products, how will you get GMP certification? Alternatively if registering an OTC with the FDA you need to provide them with the actual OTC registered manufacturer to at all be able to register the product. I’m not sure how Amazon would react to you applying as a manufacturer and your FDA registration showing your manufacturer to be a different entity, I guess you could try.

The changes are gradually rolled out this year an apply to any seller selling topicals, not only FBA users AFAIK.

[Zink]

So It seems I won’t come off as a complete nutter, we’ll see how it goes.

[Zink]

Allure labs and West Coast cosmetics both satisfy the criteria, but there might be others too!

[Zink]

@zaidjeber nope, not ok to use in the US in cosmetics, which doesn’t stop some brand from selling DMSO cream “not for cosmetic use”

The scent of DMI can be masked, really depends how much you’re using.

[Zink]

I believe DMI is better for dissolving and possibly also stabilizing BP. That being said I haven’t done any empirical testing, but it wouldn’t be too expensive, BP HPLC analysis is only $120 with Custom Analytics. 

[Zink]

It should be noted that some dermatologists and estheticians use 5-10% Retinol for peels, basically to get peeling effects and the effects or regular retinol use with less frequent applications. So depends who your customer is selling to.

[Zink]

See my discussion about it here: https://chemistscorner.com/cosmeticsciencetalk/discussion/3624/decyl-glucoside-allergen-of-the-year-2-2-contact-dermatitis-rate-in-2016-any-alternatives#latest

[Zink]

@Bobzchemist

One would think it’s not related to purity as rates were a lot lower in 2009 and there’s no reason to believe materials were purer then?

Some chain lengths are more irritating than others e.g. C18 (2011 Decyl Glucoside and Other Alkyl Glucosides as Used in Cosmetics) but Decyl Glucoside is generally found to be non-irritating, so I doubt you could fix this by selecting a different chain length glucoside.

Cross-Reactions
Reactions to multiple structurally related alkyl glucosides seem to
be frequent, but not systematic, among patch tested patients and
are seen mainly between decyl glucoside, lauryl glucoside, coco
glucoside, and cetearyl glucoside. Thus, sensitization seems to be a
group allergy with possible cross-reactivity, probably related to the
similar structure of glucosides. It is well known, however, that the
industrial manufacturing process results in blends of different alkyl
glucosides20 and patch test reactions to different glucosides may
isobornyl acrylate (Fig. 4) may possibly be a cause of sensitization to many alkyl glucosides,but this finding needs confirmation by further patch tests in pa-
tients sensitized to alkyl glucosides.5 Isobornyl acrylate is used as a
plasticizer in various plastic materials and could be leached out of
the container by the surfactant properties of alkyl glucosides.  
2017 Alkyl Glucosides in Contact Dermatitis

@Belassi what do you use currently and do you know contact allergy potential is lower?

[Zink]

Thanks BOB, yes they’re a smaller shop and at the moment have shorter lead times. 

[Zink]

Probably why they told me they were backlogged until October when I spoke to them a few months ago..

[Zink]

Thanks, I will let you know what I find.

[Zink]

I don’t believe anything, I’m looking at the data for Aquaxyl vs Dimethicone and they both reduce TEWL (according to suppliers), but if someone had real world experience with both agents used for this purpose that’d be more valuable.

[Zink]

Aquaxyl is designed to be a dimethicone or petrolatum replacement for the purpose of reducing TEWL. 

Judging from the LOI there could be as much as 2% in it (sum of the three components) - not fairy dust.

[Zink]

@zwapp Yes in case of resveratrol it’s fairly clear that we don’t need stabilized version for sunscreen formulas, the obvious thing to do to verify this is to test it. If anyone is working on this problem, they should do that verification first. It’s not unusual to see scientists missing out on obvious experiments.

I’m aware of the phototoxicity of TiO2/ZnO, this is why you use silane coating to make extra sure it’s not an issue, but even without, there’s no real evidence of danger or skin cancer correlation according to SCCP: http://ec.europa.eu/health/ph_risk/committees/sccp/documents/out135_en.pdf 

Yes I read the articles I cite, but it’s hard to respond to you when you do not cite what you refer to. Why do you think UVA matters for resveratrol when it’s absorbance peak in in the UVB range? When the sunlight experiment demonstrated 36% conversion after 2 hours exposed to direct sunlight with no photoprotection, which as I explained would not be the case for in vivo application. If you do the math I’d estimate (again, needs to be measured) that more than 90% would remain in tRes form in vivo with topical application.

Sorry if I was a bit flippant, I was hoping it would get you to pull out some references! (still hoping )

@NoHypeCosmetics thx! do share info here or through PM

 

[Zink]

I’m in California ATM! Not sure where you got Hungary from.

[Zink]

First, I read the abstract to your link about induced isomerization of resveratrol.  It looks to be irrelevant to the sunscreens questions because the wavelength tested was 260 nm, which is UVC range that doesn’t reach earth’s surface.  UVC light is what’s used for germicidal irradiation, and it’s in the range of 100-280 nm.

“trans-resveratrol has two absorption peaks
at 304 nm and 316 nm” right in the UV-B range where sunscreens typically protect the skin very well. UV-A is lower energy too.

Here’s an experiment with trans resveratrol exposed to actual sunlight, it took 2 hours to cause a ~36% conversion, in vivo it’ll only be exposed to direct sunlight for a few seconds as it goes through the stratum corneum and since UV-B transmittance of the stratum corneum at these wavelength is only around 10-20%, I highly doubt it will be an issue in a formula with a few SPF points.
https://www.researchgate.net/publication/23802677_Simple_spectrophotometric_assessment_of_the_trans-cis-resveratrol_ratio_in_aqueous_solutions

http://www.dnva.no/geomed/solarpdf/Nr_3_Nielsen.pdf

SPF 15 sunscreen blocks ~95% of UV-B. So 5% gets through, then 15% of that gets through the stratum corneum, then there is absorption by other components in the epidermis etc. Not all sunscreen ingredients degrade significantly either, definitely not mineral sunscreens. Overall this is an easy thing to solve, and I don’t think any experiments are warranted.

Also, you could still use mineral sunscreen actives in a non-sunscreen formula, so this definitely applies. Don’t waste your time solving a problem that doesn’t need solving.