180 TEXTBOOK OF COSMETIC DERMATOLOGY
to a miniaturized motor creating an oscillatory motion of the
Figure 20.2 An example of a currently marketed handheld
reusable cleansing pad for facial use.
Handheld Reusable Textured Cleansing Pads
The new environmental concerns regarding disposable cleans-
ing cloths has led to a revival of the old-fashioned cleansing
pad. Originally, these were textured flat rubber brushes with
a ring on the back for middle finger insertion. The pad had
numerous tiny rubber bristles to which soap was applied and
the face was scrubbed with finger pressure on the back of the
pad. Similar devices were in vogue for cleansing the male
scalp. These pads have seen a revival in the form of a flexible
silicone pad with numerous carefully designed fingers that are
stroked over the face (Figure 20.2). The back of the pad contains
a suction cup to adhere the pad to the mirror or shower door
for easy use. These pads are reusable and designed to allow the
cleansing fingers to adequately clean the skin in and around
the pores without injury.
MECHANIZED SKIN CARE DEVICES
Mechanization of the epidermabrasion process is known as
microdermabrasion. This is a procedure performed by esthe-
ticians and paramedical personnel where small particulates,
such as aluminum, silica, and baking soda, are sprayed against
the skin surface and simultaneously removed with a vacuum.
Microdermabrasion simply represents another technique to
induce stratum corneum exfoliation, a natural body process
that slows with advancing age.
A variety of devices are available to exfoliate the facial
skin. These include rotary brushes that drag synthetic bristles
across the skin surface to physically remove the stratum cor-
neum. These devices are sold with a special cleanser to remove
sebum and clean the bristles simultaneously. A variant of
this technology used scrubbing pads of various roughnesses
to produce exfoliation. The scrubbing pads were held on the
device head with adhesive and could be replaced when worn.
These devices vibrated instead of rotating to remove skin scale.
A third type of facial cleansing device produces a sonicat-
ing motion, similar to the sonicating electric toothbrushes. The
handheld device runs on a rechargeable battery that is attached
brush head. This oscillatory sonic motion allows the brush bris-
tles to traverse the dermatoglyphics, facial pores, and facial scars
more adeptly than other mechanized cleansing methods.
FACE MASKS
Face masks are the last ancillary skin care product discussed
and consist of substances applied to the face for an extended
time period for therapeutic and/or esthetic purposes. Masks
are available for home purchase and professional use. They
may be packaged in a jar or bottle for immediate application
to the face or as dry ingredients in a pouch for mixing with
water. Some premixed masks are applied to a disposable cloth,
similar to the cleansing cloths previously described. The cloth
is shaped to fit over the face or body area and is removed from
the pouch moistened with the ingredients and ready for appli-
cation. Once the liquids have evaporated from the mask, it is
removed and disgarded. These instant masks are very popu-
lar in the Orient, but are quickly gaining popularity around
the world for their easy use and efficiency. Typically, a mask
is applied on a weekly basis to provide a time for relaxation,
an esthetically pleasing sensation, and skin benefits. There
are four basic mask formulations: wax-based, vinyl or rubber-
based, hydrocolloid, and earth-based.
Wax Masks
Wax masks are popular among women who visit professional
spas for their warm, esthetically pleasing feel. They are com-
posed of beeswax or, more commonly, paraffin wax to which
petroleum jelly and cetyl or stearyl alcohols have been added
to provide a soft, pliable material for facial application with a
soft brush. The wax is heated in a pot placed in a water bath to
control the temperature and prevent burning. Sometimes the
wax is dipped from the pot and painted over the face and other
times it may be brushed over thin cotton gauze draped over
the face. Gauze is commonly used to enable the facial techni-
cian to remove the wax in one piece (11). Gauze also prevents
the wax from sticking to the vellus hairs on the face, which
may be painfully epilated as the wax is peeled from the face.
Wax-based face masks temporarily impede cutaneous
transepidermal water loss. This effect is limited only to the time
the mask is in direct contact with the face, unless a suitable occlu-
sive moisturizer is applied immediately following mask removal.
For this reason, they are popular in persons with dry skin.
Vinyl and Rubber-Based Masks
Vinyl and rubber-based masks are popular masks for home
use, since they are easily squeezed from a pouch onto the face
and removed in one piece. Rubber-based masks are usually
based on latex, while vinyl-based masks are based on film-
forming substances, such as polyvinyl alcohol or vinyl acetate.
Because of the concern over latex allergy, there are no true
rubber-based masks for home use.
Vinyl masks are squeezed premixed from a tube or
pouch and applied with the fingertips or a wooden applicator
to the face. Upon evaporation of the vehicle, a thin flexible vinyl
film remains behind on the face. The mask is generally left in
contact with the skin for 10 to 30 minutes and then peeled in
one sheet by loosening the edges from the face.
Vinyl and rubber masks are appropriate for all skin
types. The evaporation of the vehicle from the wet mask creates
a cooling sensation, and the shrinking of the mask with drying
may give the impression that the skin is actually tightening.
 ASTRINGENTS, MASKS, AND ANCILLARY SKIN CARE PRODUCTS
These masks can temporarily impede transepidermal water
loss while they are in contact with the skin.
Hydrocolloid Masks
Hydrocolloid masks are used both in professional salons and
at home. Hydrocolloids are substances such as oatmeal that are
of large molecular weight and thus interfere with transepider-
mal water loss. These masks are formulated from gums and
humectants and enjoy tremendous popularity since many spe-
cialty ingredients are easily incorporated into their formula-
tion. They are marketed in the form of dry ingredients in a
sealed pouch that must be mixed with warm water prior to
application. The resulting paste is then smeared over the face
with the hands or a wooden blade and allowed to dry (12).
Hydrocolloid masks leave the skin feeling smooth and
create the sensation of skin tightening as the water evaporates
and the mask dries. Temporary moisturization can occur while
the mask is on the skin. Specialty additives such as honey, egg
whites, chamomile flowers, aloe vera, almond oil, zinc oxide,
sulfur, avocado, and witch hazel may be used to customize the
mask. Many spas have their own special concoction. By vary-
ing the ingredients, masks can be created for all skin types. In
addition, herbal medicine can be practiced by combining vari-
ous healing plants into a poultice for facial application. These
hydrocolloid ingredients are well suited for the instant mask
application previously described for home use.
Earth-Based Masks
Earth-based masks, also known as paste masks or mud packs,
are formulated of absorbent clays such as bentonite, kaolin,
or china clay. The clays produce an astringent effect on the
skin making this mask most appropriate for oily-complected
patients. The astringent effect of the mask can be enhanced
through the addition of other substances such as magnesium,
zinc oxide, and salicylic acid.
SUMMARY
This chapter has discussed the various ancillary skin care
products for purchase in the current marketplace. Astringents
represent a broad category and may impart both cleansing
and moisturizing effects to the skin, depending on formula-
tion and skin type. Exfoliants, which became popular when
glycolic acid was introduced to the antiaging marketplace, can
contain both chemical and physical exfoliating ingredients to
enhance desquamation of the stratum corneum. Physical exfo-
liating agents are commonly packaged as particulate facial
181
scrubs, woven sponges, or textured cloths. Textured cloths
and reusable silicone cleansing pads are the newest introduc-
tion and can function like washcloths or may leave behind
ingredients on the skin surface. Mechanized skin care devices
attempt to deliver at-home microdermabrasion with rotary,
vibrating, or sonicating motors. Finally, face masks deliver
both esthetic and skin care benefits in a professional or home
environment.
Ancillary skin care is an interesting area that combines
devices and products to offer innovative solutions to skin care.
These products can be used alone or in combination to deliver
exfoliant, antiaging, moisturizing, astringent, or aesthetic ben-
efits. Most of the new introductions in the commercial skin care
market have occurred in this arena, since the profit margin is
high and consumers are now focusing on cleansing as a way of
enhancing the skin appearance. While cleansing has tradition-
ally been a method to obtain good skin hygiene and minimize
infection, a new concept in skin care is the expansion of cleans-
ing beyond soap and water to include astringents, exfoliants,
facial scrubs, epidermabrasion, textured cloths, mechanized
skin care devices, and face masks.
REFERENCES
1. Wilkinson JB, Moore RJ. Astringents and skin toners. In: Harry's
Cosmeticology. 7th edition. New York: Chemical Publishing
1982; pp. 74–81.
2. Dietre CM, Griffin TD, Murphy CF, et al. Effects of alpha-
hydroxy acids on photoaged skin. J Am Acad Dermatol 1996;
34:187–95.
3. Van Scott JE, Yu RJ. Hyperkeratinization, corneocyte cohesion
and alpha hydroxy acids. J Am Acad Dermatol 1984; 11:867–79.
4. Smith WP. Hydroxy acids and skin aging. Cosmet Toil 1994;
109:41–8.
5. Yu RJ, Van Scott EJ. Alpha hydroxy acids: Science and therapeu-
tic use. Cosmet Dermatol 1994; 7(10s):12–20.
6. Mills OH, Kligman AM. Evaluation of abrasives in acne ther-
apy. Cutis 1979; 23:704–5.
7. Sibley MJ, Browne RK, Kitzmiller KW. Abradant cleansing aids
for acne vulgaris. Cutis 1974; 14:269–74.
8. Durr NP, Orentreich N. Epidermabrasion for acne. Cutis 1976;
17:604–8.
9. Mackenzie A. Use of Buf-Puf and mild cleansing bar in acne.
Cutis 1977; 20:170–1.
10. Millikan LE, Ameln R. Use of Buf-Puf and benzoyl peroxide in
the treatment of acne. Cutis 1981; 28:201–205.
11. Gerson J. Milady's Standard Textbook for Professional Estheticians.
Buffalo, NY: Milady 1992; pp. 240–242.
12. Draelos ZD. Cosmetics in Dermatology. 2nd edition. Edinburgh:
Churchill Livingstone; WB Saunders 1995; p. 213.
 21
Regulatory Overview of Cosmeceuticals
Lauren A. Hassoun, Howard I. Maibach, and Raja K. Sivamani
Cosmeceuticals are an intriguing and burgeoning field within
dermatology and the skin care market. This industry was esti-
mated to have generated approximately $8.2 billion in sales in
2012 (1). Furthermore, researchers focusing on cosmeceutical
products highlight strong growth perspectives in the com-
ing years with a rapid compound annual growth rate of 7.7%
and the global cosmeceutical market reaching $42.4 billion by
2018 (2). While consumers in the United States spend more on
cosmeceutical products than all of Europe combined, consum-
ers in France and Germany spend the most within Europe (3).
Although there is no strict definition for cosmeceuticals within
the skin care industry or dermatology realm (4), they are typi-
cally considered cosmetic products with components that have
“drug-like” benefits and properties. Examples of cosmeceuticals
include moisturizers, serums, topical antioxidants, retinoids,
peptides, and botanicals. As a category, they are believed to
contain either one or a mix of ingredients that improve skin
condition and appearance without making an explicit asser-
tion on skin health. In addition to their aesthetic properties
which make them desirable for both consumers and patients,
development of cosmeceutical products has several economi-
cal advantages, as the process of marketing them is simpler and
they require less monetary investment than a drug, which may
require from $800 million to upward of $1 billion (5).
REGULATORY OVERSIGHT
The term “cosmeceuticals” is derived as an amalgam of cos-
metics and pharmaceuticals. The Food and Drug Association
(FDA) does not formally acknowledge the term “cosmeceuti-
cal” but notes that the term is used by the cosmetic industry
to refer to cosmetic products that have medicinal or drug-like
benefits (6).
It is necessary to distinguish between cosmetics, drugs,
and cosmeceuticals. Cosmetics are defined as either (1)
articles intended to be rubbed, poured, sprinkled, or sprayed
on, introduced into, or otherwise applied to the human
body or any part thereof for cleansing, beautifying, promot-
ing attractiveness, or altering the appearance, or (2) articles
intended for use as a component of any such articles. Cosmetics
are recognized by the FDA, however approval is not required
for marketing (6).
Drugs are defined as (1) articles recognized in the offi-
cial United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, or official National
Formulary, or any supplement to any of them, (2) articles
intended for use in the diagnosis, cure, mitigation, treatment,
or prevention of disease in man or other animals, (3) articles
(other than food) intended to affect the structure or any func-
tion of the body of man or other animals, and (4) articles
intended for use as a component of any article specified in
clause (1), (2), or (3). Drugs are recognized by the FDA and
unlike cosmetics, approval is required for marketing (6).
Cosmeceuticals are cosmetic products that have medici-
nal or drug-like benefits. They are not recognized by the FDA
and approval is not required for marketing if pharmaceutical
claims are not made (5).
In the United States, regulatory oversight for the cosme-
ceutical industry is primarily provided by the FDA. As long
as no claims that would meet criteria for evaluation as a drug
are met, cosmeceuticals are regarded as cosmetics for regula-
tory purposes. The FDA does not possess any legal authority
in the approval of cosmetic products before they are marketed,
but if a cosmetic product is determined to be misbranded or
adulterated, they are able to take legal action. Thus, while cos-
meceuticals may contain drug-like benefits, there is no regu-
latory approval mechanism insofar as the cosmeceutical does
not make a claim that would qualify it as a drug.
The regulation of cosmeceuticals is not well defined
outside the United States. For example, in Europe, regulatory
authorities consider many cosmeceuticals as cosmetics (3)
while in Japan, they are treated as quasi-drugs (3). Even more
obscured is the process in India, where multiple regulatory
bodies may be involved without guidelines on product aims
for cosmetics and the term “cosmeceutical” is not included in
official legal definitions (3).
THE ROLE OF BOTANICALS
Botanicals have an expanding role in cosmeceuticals due to the
rapidly growing demand for the use of complementary and
alternative medical therapies (7). Specifically, several studies
have evaluated the ability of whole botanical extracts and spe-
cific phytochemicals to modulate cellular functions (8–10). In
this regard, botanicals may have valuable properties in addi-
tion to a cosmetic purpose. Yet despite these encouraging data,
official claims need to remain guarded to be marketed as cos-
meceuticals rather than a drug.
Some botanical products have blurred the boundar-
ies of cosmeceuticals and drugs. For instance, two botani-
cally derived dermatological preparations have received FDA
approval as prescription drugs. One is an extract of Camellia
sinensis (green tea) composed of sinecatechins that is used for
the topical treatment of external genital and perianal warts
(11). The second is a purified proanthocyanidin extracted from
the South American tree Croton lechleri for the treatment of
diarrhea associated with anti-HIV drugs (12).
In recent years, there has been greater demand for
“organic” cosmeceuticals as a result of the growing demand
for natural and botanical alternatives. In the United States,
the standards for “organic” are not set by the FDA but by the
United States Department of Agriculture (USDA). The FDA