[Abdullah]

Perry said:

@amitvedakar - I doubt it. The surfactants are emulsifying oils so most of the salicylic acid will be tied up in a micelle & not in contact with skin. 

Can’t polymer help salicylic acid deposition the same way it does help silicone deposition?

[Abdullah]

Perry said:

Probably not but you could ask some other supplier what theirs is. It wouldn’t be a bad guess to assume they are about the same. Although it could be easily wrong

Thanks 

I wanted to purchase it from local suppliers who are resellers but they don’t know about those things. 
I thought maybe from melting point or something else i van guess it more correctly. 

[Abdullah]

What is your pH? 

[Abdullah]

As Mr PhilGeis said, have you tested microbial contamination? 

Your preservative looks weak against fungi for me. Mr PhilGeis know better about it. 

If they are formed in one day after production it may be oxidation of iron or something else in product, not contamination.

You can dissolve 0.3% EDTA in water and then add to a small amount of this batch and see if it improves it. Or make a new sample batch with 0.2% EDTA and see if it has this discoloration.

[Abdullah]

ketchito said:

@Abdullah Since salicylic acid is an acid, you need to consider its pKa. If your pH is below SA’s pKa, then SA will be present as an acid (protonated), but if the pH is above SA’s pKa, then  it will exist in its unprotonated form, that is, hydronium ions (positive) and salicylate ions (anionic), both swimming around the solution. That works for all acids.

Thanks 

Is this rule only for salicylic acid or for everything? 

For example: lactic acid and glycolic acid at pH 5, will it also be mostly in anionic form?

[Abdullah]

Write your formula.

Also, does it appear when the product is in production tank or after you have transfer it to final package?

[Abdullah]

Pattsi said:

Flow chart summary.

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/New-Drugs/Process/NDD_APPL_Organogram.pdf

You can contact your local state authority if your formula requires clinical trial or not. 

Thanks

[Abdullah]

@PhilGeis @MarkBroussard got it

Thanks a lot 

[Abdullah]

And is there any general rule to know which ingredient is anionic, cationic or non-ionic? 

I did search a lot about salicylic acid charge in Google but couldn’t find any information about it.

[Abdullah]

Thanks @ketchito 

I didn’t know salicylic acid was anionic. 

These two ingredients are both effective for acne so i wanted to use both of them in a single product to make it supper effect  .

The goal is to sell the product as a simple leave on liquid solution to minimize the cost. 

Are you suggesting an anionic surfactant to make the product a cleanser or there is another reason for using that? 

[Abdullah]

Rockstargirl said:

Abdullah said:

Rockstargirl said:

The ingredients and % determine if is a drug or a cosmetic. Soap is a cosmetic. So if they make a “cures acne” claim - that is incorrect for a cosmetic. “Helps the appearance of acne” may be more suitable. The claim itself does not make it a drug. The man power of health authorities is not great and lots of this falls under the radar. However the fines levied when caught are no joke. It’s not worth the risk. Research what claims are allowed and the wording before marketing. I believe BP and Sal acid may make acne claims however “ cure” is not a word I would use. 

Thanks 

One particular question. 
Are OTC products controled by regulations to see if it realy do what it claims?

Well.. some is already established (spf filters etc) But you should do testing to back up your claims. The responsibility is of those making the claim.  

My point was also this. 

If salicylic acid from cleanser is useless, how do all these salicylic acid OTC acne cleansers back up their claims? 

[Abdullah]

MarkBroussard said:

@Abdullah

People with acne will normally use a suite of products, including leave-on products which is where they get the benefit, from the leave-on products, not the cleansers.  But, adding SA to a cleanser certainly will not hurt, it just won’t do very much in terms of effectiveness in delivering an active against acne.

That makes sense
Thanks a lot

[Abdullah]

PhilGeis said:

Assume you’re looking at the skin protectant monograph.
What is your intent for the glycerine use?

This was as an example because i couldn’t tell you properly what i wanted to know about salicylic acid in cleansing product.

I am looking at acne monograph.
2% salicylic acid is an OTC active for ance. 
Now if it is in a cleansing product, it doesn’t do any benefit for ance vs simple cleansers. So how are all OTC salicylic acid cleansers which doesn’t do anything for ance being allowed to claim so?

Salicylic acid for ance from cleanser is as useless as glycerin for skin protection from a cleanser. Isn’t it? 

[Abdullah]

@PhilGeis thanks.

The particular thing i want to know is this. 

For example: 40% glycerin is an OTC active ingredient. you can use 40% glycerin in a lotion, claim for skin protection and register the product as OTC. 

Now if you use 40% glycerin in a cleanser, can you register it as OTC and claim skin protection from it? 

[Abdullah]

ozgirl said:

I remember reading somewhere that the issue is that young children already have potentially high salicylate exposure due to teething gels and thus adding an extra exposure may make it unsafe.

The European Cosmetics regulations are based on science so I personally wouldn’t risk it when you have an alternative that is safe and works.

Salicylic Acid is also restricted under ASEAN Cosmetic regulations and is not to be used in products for children under 3 (except shampoo).

Thanks

[Abdullah]

Rockstargirl said:

The ingredients and % determine if is a drug or a cosmetic. Soap is a cosmetic. So if they make a “cures acne” claim - that is incorrect for a cosmetic. “Helps the appearance of acne” may be more suitable. The claim itself does not make it a drug. The man power of health authorities is not great and lots of this falls under the radar. However the fines levied when caught are no joke. It’s not worth the risk. Research what claims are allowed and the wording before marketing. I believe BP and Sal acid may make acne claims however “ cure” is not a word I would use. 

Thanks 

One particular question. 
Are OTC products controled by regulations to see if it realy do what it claims?

[Abdullah]

By using cationic surfactants like SPDMA and BAPDMA you feel that your hair volume has increased because it doesn’t weight down the hair like BTMS does. 
This was my experience 

[Abdullah]

@ozgirl thanks 

As i am not in Europe, this doesn’t apply to me. In fact there is no regulation about it here.
My concern is about it’s safety for babies.
Is it safe for babies?

Is it allowed in in US or any other improved county in baby leave on product? 

[Abdullah]

@Pharma so these people with acne are leaving a soap with salicylic acid for five minutes on their face to get some benefit or they are rinsing it before one minute and getting no benefit for acne. Am i correct? 

[Abdullah]

MarkBroussard said:

@abdullah:

Yes, any cleanser containing 2% SA and making Acne claims under the FDA monograph would be an OTC.  That is primarily for marketing purposes so you can market it as an Acne OTC product.

Thanks a lot

[Abdullah]

@Perry @MarkBroussard @Pharma   so what about OTC benzoyl peroxide cleansers and salicylic acid cleansers and soap’s?

Can a product that doesn’t do any benefit except just being a cleanser be called and registered as an OTC drug? 
If salicylic acid from an OTC cleanser or soap is not doing anything then it is just a cleanser or soap called OTC with doing nothing, right? 

[Abdullah]

@Pharma WOW

Is it only salicylic acid that doesn’t do anything for acne and dandruff from rinse off product or benzoyl peroxide also doesn’t do anything from rinse off product? 

[Abdullah]

Yes that is the problem. 

In large batch it needs more mixing so the percentage of NACL would be 2% in every part. If it is in powder form and little mixing, concentration of NACL in one part would be too much and in another part too little so they cant provide viscosity.

If you have made the same formula in smaller sample quantity and the viscosity was enough then the problem in this big batch is not enough mixing. By mixing more its viscosity will increase.

[Abdullah]

If you want to save this batch you can always use a polymer like HPMC or xanthan gum depending on your mixing machine

[Abdullah]

You can use more NACL and see if that solves the problem. 

Also, are you sure it is coco glucoside and not decyl Glucoside?

Also don’t use fragrance and glycerin in a sample and see if it is the cause.