Is it safe to formulate 2% salicylic acid or 8% lactic acid at pH 3?

Tagged: exfoliant, lactic acid, ph, salicylic acid

Formulating

Is it safe to formulate 2% salicylic acid or 8% lactic acid at pH 3?

Posted by Abdullah on October 16, 2021 at 5:46 am

I want to formulate a 2% salicylic acid product and a 10%(8%active) lactic acid product at lowest pH that is not hurtful for skin. So is pH 3 safe?

If no then what is the lowest safe pH?

Abdullah replied 3 years, 4 months ago 4 Members · 12 Replies
12 Replies

Microformulation

Professional Chemist / Formulator
October 16, 2021 at 2:07 pm

https://www.fda.gov/cosmetics/cosmetic-ingredients/alpha-hydroxy-acids
Abdullah

Entrepreneur
October 16, 2021 at 3:10 pm

@Microformulation thanks

What about salicylic acid?
Microformulation

Professional Chemist / Formulator
October 16, 2021 at 3:23 pm

Anything above 2% is OTC so you have a hard limit with SA. 10% AHA with 2% BHA would be fine, but I would keep the pH >3.5.
Abdullah

Entrepreneur
October 16, 2021 at 4:15 pm

@Microformulation
What percentage minimum and maximum salicylic acid and lactic acid are OTC? In separate products.

I was thinking 0.5-2% salicylic acid is OTC.
Microformulation

Professional Chemist / Formulator
October 17, 2021 at 2:10 pm

Minimum? You don’t really worry about how little one puts in, although it would likely be ineffective.

2% and below Salicylic acid is fine. Greater than 2% makes it an OTC Drug under the Acne OTC Monograph.

Lactic Acid doesn’t have an OTC limit but from experience I would follow the 10% AHA limit and the >3.5 pH recommendation. I know of a line that ignored this limit and faced a threatened lawsuit. In the lawsuit they cited the CIR limits, established the credibility of the CIR, and then alleged that the line ignored a credible guideline.
Abdullah

Entrepreneur
October 17, 2021 at 2:24 pm

@Microformulation i am not in US and not selling in US so those restrictions aren’t for me but as guidelines.

If something is OTC in US it means that product is curing a disease. Am i correct?

I want to cure the problems with these ingredients but not in US and there is not restrictions for these ingredients in Asia.
Abdullah

Entrepreneur
October 17, 2021 at 2:45 pm

@Microformulation salicylic acid greater that 2% up to what percentage for acne for daily use?
Microformulation

Professional Chemist / Formulator
October 17, 2021 at 2:55 pm

I practice in the US: https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-acne-drug-products
MarkBroussard

Professional Chemist / Formulator
October 17, 2021 at 2:59 pm

The FDA Acne Monograph covers Salicylic Acid in the range 0.5% to 2.0%. You can use Salicylic Acid in formulations within that range provided you do not make Acne claims. For Salicylic Acid above 2%, but more in the range of 10% to 15% you are getting into Wart Removal OTC products and chemical peels.
Abdullah

Entrepreneur
October 18, 2021 at 3:05 am

@MarkBroussard @Microformulation thanks
Pattsi

Member
October 18, 2021 at 6:52 am

Abdullah said:

I want to cure the problems with these ingredients but not in US and there is not restrictions for these ingredients in Asia.

There is, please check with your local authority.

If you are India-based, you fall under The Drugs & Cosmetics Act 1940 and Cosmetics Rules 2020.
https://legislative.gov.in/sites/default/files/A1940-23.pdf
https://thc.nic.in/Central%20Governmental%20Rules/e%20Cosmetics%20Rules,%202020.pdf
https://law.resource.org/pub/in/bis/S11/is.4707.2.2009.pdf
Abdullah

Entrepreneur
October 18, 2021 at 10:36 am

@Pattsi thanks for the files.
Are you in India?