cosmetic

1. “What’s the difference between an over-the-counter (OTC) skin care product and a professional
or cosmeceutical skin care product?”
As we’ve come to learn over time… OTC beauty products are regulated by the US Food and
Drug Administration (FDA) and can only penetrate the first layer of your skin…aka the “dead
layer”. Professional products (cosmeceuticals) are not controlled by the FDA and penetrate the
bottom layers of the epidermis… aka “live tissue”!
Now you may be wondering how this is possible… Let me explain.
The FDA recognizes two categories: pharmaceutical and OTC cosmetics, which are defined as…
Pharmaceutical or drug:
“Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”
and “articles (other than food) intended to affect the structure or any function of the body of man
or other animals” [FD&C Act, sec. 201(g)(1)].
Topical pharmaceuticals penetrate through the layers of the epidermis and affect the structure
and function of the skin (think of prescription topical steroids or Retin-A).
OTC Cosmetic:
“Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the
appearance without affecting the body’s structure or function.” [FD&C Act, sec. 201(i)].
Since many consumers “self-diagnose” when choosing a skin care product from a
department/drug store, these products must be made safely. Meaning, big cosmetic companies
cannot afford to have a huge number of consumers with issues from using very active products
— so, that skin care product may feel good and smell good, but, most likely won’t have a lot of
activity in its formulation.
Also, since cosmetic companies really don’t have to prove efficacy, the special active ingredient
listed in the formula only has to appear somewhere on the ingredient list – ingredients are listed
in content order, from most to least, so if you see that ”active” on the last half of the list (usually
alphabetically) you can bet you are getting a tiny percentage (enough to be effective in the
formulation?) of that specific ingredient.
Lastly, OTC cosmetics are also manufactured and distributed in very large batches, and are
packed with almost as many preservatives as “active” ingredients! Many over-the-counter
cosmetics simply do not penetrate the skin barrier, where the ingredient formula would have a
therapeutic benefit to the skin.

2. Oh, and by the way… Sephora, Macy’s, Nordstrom, & Saks products (to name a few)… Are all
OTC!
Cosmeceutical:
The term “cosmeceutical” was created in 1990s from cosm(etic) + (pharma)ceutic. It’s a
cosmetic product claimed to have medicinal or drug-like benefits. Cosmeceutical products are
marketed as cosmetics, but reputedly contain biologically active ingredients. While drugs are
subject to a review and approval process by FDA, cosmetics are not. In other words, the formula
does not technically have to prove efficacy or safety, but it does contain an ingredient that may
have activity in the skin.
FYI… it’s not just about one really fabulous ingredient — it’s the mixture of the right amounts
of active ingredients working together that works best in the skin, similar to how oral
multivitamins work internally in our bodies with a mixture of vitamins and minerals for best
absorption.
So, since nurses & estheticians do not prescribe pharmaceutical products, offering a well
formulated and tested cosmeceutical line, like SkinMedica, is the next best option to
pharmaceuticals. Cosmeceuticals that are professionally recommended by a licensed skin care
professional generally have a higher amount of active ingredients with proven and safe
formulations, and offer delivery systems that reach targeted cells in the skin. To put it simply…
It really works and you will see results!
Article by: Kelly Dobos
When developing products we oftenwalk a fine line in terms of formulatingfor efficacyand
marketing claims. It is important to understand the regulatoryand legal implications of the
decisions we make.
Cosmetic or Drug?
In the UnitedStates, the Federal Food, Drug and Cosmetic Act defines cosmetics as “article
intended to be rubbed, pour, sprinkled, or sprayed on, introducedinto, or otherwise applied
to the human body… for cleansing, beautifying, promotingattractiveness, or alteringthe
appearance.” Examples include blush, lipstick, nail polish, shampoo, and toothpaste.
But once the product claims venture into diagnosis, treatment, or preventionof disease and
alleges to affect the structure or anyfunctionof the body, the product is a drug. Drugs are

3. subject to stringent regulations, labeling(actives are calledout from other ingredients) and
testingrequirements, whichresult inthe investment of both time and money.
Products canbe both cosmetic anddrug if the intendeduse meets bothdefinitions.
Moisturizerswithsunscreens, moisturizinghand sanitizers, and anti-dandruff shampoos all
fall into this category. These cosmetic/drugcombinations are subject to the regulations for
both drugs and cosmetics. They are consideredOTC or Over the Counter drugs.
Soaps
True soaps represent anadditional categoryand are regulatedby the Consumer Products
Safety Commission, not the FDA. True soaps are made purely of fat and alkali. Soaps made
with any other ingredient or claim any other benefit like moisturizationor deodorizingare
cosmetics.
Cosmeceuticals
One other classificationof products is cosmeceuticals. The oft-controversial but significant
contributor to our field, dermatologist Dr. Albert Kligman, coinedthe term cosmeceutical
almost 30 years ago. He definedcosmeceuticals as topicallyappliedproducts that do have a
physiological effect onthe skin. The industry was quick to respondbecause the potential
regulationof cosmetics as drugs couldcripple innovation due to time and cost. Kligman,
however, intendedto draw attentionto the potential biological effects of all cosmetics that
did not just merelycamouflage or add color. In fact he said it was “scientificallysillyto
pretendthat cosmeticsdidnot do anything” and that cosmeticsmight actuallybe doing a lot
of good.
The term cosmeceutical is not recognizedas part of the Federal Food, Drug, and Cosmetic
Act. But whether you agree or disagree, this term has become part of our consumer’s
vernacular. The controversyand conversationthe term has createdremains, in my mind, one
of Kligman’s great contributions to cosmetic science.
Further informationcanbe found on the FDA’s website.
Cosmetics
The Food, Drug and Cosmetics Act (FD&C Act) defines a cosmetic by its intended
use, meaning cleansing, beautifying, promoting attractiveness or altering appearance. Products

4. in this category include lipstick, perfumes, skin moisturizers, nail polish, shampoos, deodorants
and any other beautifying product. [FD&C Act, sec. 201(i)].
Cosmeceuticals
The US Food and Drug Administration (FDA) does not consider the term cosmeceuticalto be a
valid product class. It is a term coined by the cosmetics industry applied to products that are
said to bridge the gap between cosmetics and drugs. The term cosmeceutical often is used in
cosmetic advertising and may be misleading to the consumer. If the consumer
interprets the product as being similar to a pharmaceutical, he or she may conclude that
cosmeceuticals are required to undergo the same efficacy and quality control testing as is
required for a medication.
Drugs
Drugs are either over-the-counter (OTC) or prescription (Rx) and are regulated by the FD&C Act
as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease," and "articles (other than food) intended to affect the structure or any function of the
body of man or other animals" [FD&C Act, sec. 201(g)(1)]. Everyday prescription drugs
are referred to as legend drugs, which are separated from controlled substances by the FDA.
Since a deodorant only masks odor and an antiperspirant actually stops perspiration, i.e.,
affects function, a deodorant is a cosmetic and an antiperspirant is a drug. The same argument
can be made for dandruff shampoo, toothpaste with fluoride, and any product with a sun
protection factor (SPF). Prescription strength skin care products are only available through a
physician.
To provide some clarification, shampoo is a cosmetic, but dandruff shampoo is an OTC drug;
toothpaste is a cosmetic, but toothpaste with fluoride is an OTC drug; and makeup is a
cosmetic, but makeup with an SPF claim is an OTC drug