Cosmetic, OTC + Prescription Skincare
The information for this post comes from FDA.com; I also had it reviewed for accuracy by the lovely Jen, @theecowell who is a cosmetic scientist, and from my professional experiences as a product developer where a big part of my job responsibilities is understanding and following regulations.
I will add that I wasn't aware of these things before I had the opportunity to develop products. I believed what brands told me...which were often incorrect, and at the end of the day, they were trying to market to estheticians as well, so we would sell their products. Let's get the correct information out there once and for all! Please note, this information is in regards to USA regulations.
Cosmetic
Definition: “Cleansing, beautifying, promoting attractiveness or altering the appearance”
A cosmetic is not required to be approved by the FDA.
A brand decides where they want to be sold but there are no legal requirements - i.e. exclusive to physicians, licensed professionals, etc.
Does not require proof of efficacy testing/clinical trials (just standard safety testing.)
No legally required percentages of actives or "pure" ingredients.
Cannot claim to change the structure and function of the skin.
This includes:
“Medical Grade” - I realize this may be shocking to some (particularly estheticians) but what is referred to as “medical grade skincare” is not a regulated term and those products that are sold in med spas, doctors’ offices, etc. are still considered a cosmetic. There are no regulations or rules of certain percentages, quality of ingredients, clinical testing, etc. I refer to products sold in a med spa or a physician’s office as “physician-dispensed skincare.”
“Professional Grade” - Essentially a brand creates larger size packaging and fills it with the same retail formula. A brand may create a few "professional only" products like a high percentage peel or a specialty mask. This keeps people coming back to receive treatments with products that aren't available to the public and it also
Liability insurance
Safety for untrained people
“Cosmeceutical” - No meaning under FDA law.
Brands sold at Sephora/Ulta, Target/Walmart, Drugstore brands, etc. - Often referred to as “OTC” - See correct definition below.
Types Of Cosmetic Products:
Deodorant
Nail polish
All makeup
Perfume
Cleansers
Toners
Serums
Moisturizers
Eye cream
Retinol under 1%
Exfoliants
Face masks
Haircare
Body care
Over The Counter (OTC)
PLEASE NOTE: Many refer to products sold at drugstores, Sephora, Ulta, Target, etc. as OTC. This is not the correct definition and is not the same thing as what the FDA refers to as an OTC topical product.
Definition: Contains a “drug” ingredient and is regulated as a drug but does not require a prescription.
Makes a drug claim. i.e. sunscreen claims to protect the skin from sunburn.
Must follow an FDA monograph (this is a set of rules with acceptable ingredients, formulations, doses, and labeling.
The package is required to have a drug fact box.
Types Of OTC Products:
All sunscreen products - face, body, baby/kids SPF
Some acne medications
Healing lip balms
SPF Lip Balms
Lotions intended to treat eczema
Antiperspirant deodorants
Differin (Adapalene)
Most toothpaste (fluoride)
Personal Lubricants
Medicated Shampoo
Prescription
Definition: Regulated as a drug, intended to treat a medical condition, and requires a prescription by a healthcare provider (MD, PA, NP, etc.)
Can be purchased from your doctor's office or your pharmacy (this varies.)
Some prescription topicals are covered by health insurance.
Rigorously tested in clinical trials and must be approved by the FDA.
Types Of Prescription Skincare Products:
Salicylic acid over certain %
Benzoyl Peroxide over certain %
Latisse (eyelash growth serum)
Retinoids like Tretinoin
Hydroquinone (skin lightening cream)
Some acne medications - Epiduo (Adapalene/Benzoyl peroxide)
Rosacea medication - Metrogel (Metronidazole)
Below is a popular infographic that has been shared all over social media which is extremely incorrect. Let’s break this down!
