Medical-grade vs. OTC


Ever wonder what the difference is between medical-grade/professional/cosmeceutical skincare vs. over-the-counter (OTC) skincare? Before we dive in, it's important to point out that marketing terms represented on product packaging may not always be scientific nor legally defined nomenclatureshypoallergenic as an example.


With this in mind, we researched an assortment of explanations to better understand skincare distinctions, and rested upon insights from noted skin care expert, Renee Rouleau. Here is an excerpt from her blog post.


“Medical-grade products are stronger and more potent than ‘regular’ skincare products. They may be too harsh for my sensitive skin.” This is possible, but not always the case. A product marketed as medical-grade could be too harsh for your skin, but so could a product NOT marketed as medical-grade. Some people think that medical-grade products contain higher percentages of certain ingredients than other products, but that’s not the case anymore. (Also, ingredient percentages aren’t everything.)


“You can only get it with a prescription and should use it under dermatologist supervision.”

False. Medical-grade and prescription formulas are two very different things. Whereas medical-grade is an unregulated term (often used to market a product a certain way), prescriptions are heavily regulated. Prescriptions are required to go through many rounds of rigorous testing and clinical trials before being approved by the FDA. Because prescription products are classified as medications, they should be used under the supervision of a doctor or dermatologist. Products could be labeled “medical-grade” without going through any special testing and aren’t considered medications. (Although many brands who choose to market their products as “medical-grade” will often have clinical studies to back up the claims).


“Medical-grade skincare uses higher quality ingredients than other products. These ingredients have been tested.”

According to Dr. Mariwalla, while medical-grade products were originally considered a step up from regular, over-the-counter products sold in grocery stores or beauty retailers, this isn’t necessarily the case anymore.

“As skincare has become more sophisticated, many brands have started to step up their ingredient game,” Dr. Mariwalla said. “Physician-dispensed products have also tried to go mainstream, thus blurring the lines between OTC drug or department store and medical-grade.”


At the end of the day, all of us formulators have access to most of the same ingredients when it comes to creating a skincare product. Very few ingredients are proprietary anymore. For example, PHAs (a class of exfoliating acids) used to be patented by NeoStrata until recently. Now that the patent has expired, you’ll see them popping up in more and more products.


As far as testing ingredients, there are five main ways companies do this:

  • Clinical testing, which is a claim-substantiation test that allows you to make claims based on certain test results.

  • 48-hour irritancy study, which determines if a product will cause irritation by breaching the skin’s barrier.

  • In-house consumer testing, which bases a product’s claims off of the statements made by 20-30 consumer test subjects.

  • Repeat insult patch test, which determines the likelihood of product causing skin rashes such as contact dermatitis.

  • Ophthalmologist testing, which helps to ensure that a product made for the eye area won’t cause irritation should it make its way into the eyes.

It’s important to note that ANY skincare brand can choose to put their products through these tests. It’s possible that a medical-grade brand is more likely to put their products through clinical testing, but again, it’s not a guarantee.


“Medical-grade products can only be bought at a medspa or doctor’s office.”

Also not true! While this used to be the case back when medical-grade products first came on the scene, the internet has changed the way we purchase skincare. Now, you can buy brands considered medical-grade through online retailers or even at more upscale department stores.


“Medical-grade skincare is more ‘worth it’ than ‘regular’ skincare.”

At the end of the day, this just isn’t a blanket statement that can be made. While there are a lot of really great brands out there that call themselves medical-grade, this is a marketing term at the end of the day. Every brand sets out to deliver results for the skin, and which ones you use will depend entirely on your personal skin goals and skin type.


“Professional products will be more effective and give better, faster, more noticeable results than ‘regular’ skincare products.”

Similar to so called "medical-grade" products, professional products could have “stronger” formulas, meaning formulas with higher percentages of ingredients like acids and retinol. This could potentially drive a faster result, but it could also be more likely to cause skin barrier disruption and irritation. You just can’t make a blanket statement for all. It really just depends on the product and ingredients you’re talking about.


“Professional products are more expensive.”

This can definitely be true since they’re theoretically harder to get than products sold in beauty retailers or online, but I would caution anyone thinking of spending a crazy amount on a single product just because it’s marketed as professional. Again, skincare has come a long way, and almost everyone has access to the same quality ingredients for product formulation.


“The product and ingredients have been approved and endorsed by a qualified skincare professional”

This isn’t necessarily true as you can’t guarantee that anyone in particular is vouching for a product just because it’s marketed as professional. The best way to know who endorses it is to look at the source. If you get it from a practitioner who recommends it to you, I would consider that an endorsement, but this is more on an individual basis. Again, there are no special requirements for testing or reviewing products in order to label them as professional.


Information courtesy of www.ReneeRouleau.com, a website with helpful skin tips and advice from skin care expert and celebrity esthetician, Renée Rouleau.