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S K I N C A R E

©2015 Swiss-American. All rights reserved. EltaMD is a registered trademark of Swiss-American. 88-534 Rev. 4/15

EltaMD®: The Science of Skin Care Delivered Safely

Available only throughapproved physicians.

EltaMD Barrier Renewal Complex Product Information Ceramide and enzyme therapy

• Visibly improves skin appearance• Promotes healthy skin barrier• Replenishes moisture

EltaMD® Barrier Renewal Complex is clinically proven to moisturize the stratum corneum and improve dry, compromised skin after a single application within 24 hours. This advanced formula works to visibly minimize the appearance of fine lines and wrinkles while significantly improving skin texture, tone and pore size. A selected blend of ceramides and other essential lipids help strengthen the barrier and restore its natural hydration system. Enzymes and vitamins minimize inflammation and promote skin cell turnover. Within 21 days, skin appears softer, smoother, healthier and more youthful. EltaMD Barrier Renewal Complex is fragrance-free, paraben-free, sensitivity-free and noncomedogenic.

Use to achieve and maintain a healthy skin barrier, replenish moisture and reduce the appearance of fine lines and wrinkles.

Apply morning and night to face, neck, and décolletage. For day-time use, follow with EltaMD sunscreen as directed by a physician.

1.7 oz / 48 g Airless pump

Varies by application amount and size of area covered

Purified Water, Ethylhexyl Isononanoate, Niacinamide, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Ceramide NP, Cholesterol, Ceramide EOS, Cetyl Alcohol, Ceramide NS, Ceteareth-25, Ceramide EOP, Caprooyl Sphingosine, Caprooyl Phytosphingosine, Ceramide AP, Hyaluronic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xylitylglucoside, Squalane, Anhydroxylitol, PEG-7 Trimethylol-propane Coconut Ether, Polyisobutene, Piptadenia Colubrina Peel Extract, Actinidia Chinensis (Kiwi) Fruit Extract , Bromelain, Tocopherol, Xylitol, Ficin, Glutamine, Biotin, Proline, Behenic Acid, Carbomer, Citric Acid, Sodium Hydroxide, Butylene Glycol, Benzyl Alcohol, Potassium Sorbate, Phenoxyethanol, Hexadecanol, Sodium Bisulfite, Disodium EDTA.

Physician-dispensed only

02562

Label uses

Directions

Package size/dispenser

Applications per package

Ingredients

Availability

Item #

CERAMIDE& ENZYMEFORMULA

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AAD 2016 Poster Presentation on pages 3-4.

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skin

may

be

indu

ced

by o

ne o

r mor

e fa

ctor

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ch

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w h

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se o

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t sym

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se

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hyd

ratio

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tely,

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flam

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mid

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st m

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as d

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oped

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netic

and

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age

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PRO

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WIT

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PEC

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ZED

MO

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RIZE

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Mel

anie

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imm

s¹ ,

Laur

a K.

S. P

arne

ll, B

S, M

Sc²

Swiss

‐Am

eric

an P

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rollt

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reci

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issou

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ity, T

X

As e

xpec

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bot

h pr

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ts ha

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nific

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mpr

ovem

ents

in h

ydra

tion

and

skin

dry

ness

in a

s lit

tle a

s 4

hour

s an

d 24

hou

rs fo

llow

ing

a sin

gle

appl

icat

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as w

ell a

s du

ring

the

3 w

eek

study

per

iod.

Sig

nific

ant i

mpr

ovem

ents

in

TEW

L, sk

in to

ne, f

ine

flake

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kes

desq

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dex

valu

es w

ere

also

see

n fo

r bot

h pr

oduc

ts. H

owev

er,

signi

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t im

prov

emen

ts in

ext

ensib

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pur

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astic

ity

and

biol

ogic

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men

t ove

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test

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roup

. Th

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nific

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redu

ced

pore

siz

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as

littl

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k an

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roug

hout

the

entir

e stu

dy.

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cont

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rizer

was

sta

tistic

ally

out

perfo

rmed

fo

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e siz

e an

d vi

sible

sm

ooth

ness

. With

in 2

1 da

ys,

100%

of t

est p

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ubje

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had

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t visi

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and

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ss im

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ay b

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use

in

mai

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and

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g co

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omise

d sk

in q

uick

ly.

Abs

tract

Ack

now

ledg

men

ts &

Dis

clos

ures

Stud

y C

ondu

cted

by

Thom

as J.

Ste

phen

s &

A

ssoc

iate

s, In

c., R

icha

rdso

n, T

exas

and

Col

orad

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rings

, Col

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o

Stud

y fu

ndin

g sp

onso

red

in fu

ll by

Sw

iss-A

mer

ican

Pr

oduc

ts, In

c. (C

arro

llton

, Tex

as)

Intro

duct

ion

Dry

ski

n is

char

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rized

by

a la

ck o

f eith

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pids

, w

ater

or b

oth,

resu

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in ti

ghtn

ess,

flak

ing

and

infla

mm

atio

n. S

kin

may

app

ear d

ull,

espe

cial

ly o

n th

e ch

eeks

and

aro

und

the

eyes

. It m

ay la

ck e

lasti

city,

pr

esen

ting

acce

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ted

fine

lines

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. In

mor

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vere

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tchi

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nd b

urni

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ay o

ccur

. Dry

ski

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n be

gen

etic

ally

det

erm

ined

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rigge

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by e

xter

nal

fact

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such

as

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ironm

ent,

cosm

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edic

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ns. I

t can

also

be

a na

tura

l con

sequ

ence

of

the

agin

g pr

oces

s, a

s se

bum

pro

duct

ion

slow

s do

wn.

8-62

5 R

ev. 3

/16

EltaMD® Barrier Renewal Complex is clinically proven to moisturize the stratum corneum andimprove dry, compromised skin in just 24 hours after a single application.

Sub. 1. Subject shows a statistically significant improvement in skin barrier function as measured by a decrease in transepidermal water loss, compared to untreated skin. Unretouched photographs of subject at baseline and after 21 days of twice-daily use of EltaMD Barrier Renewal Complex.

Sub. 21. Subject shows a statistically significant improvement in skin elasticity. Unretouched photographs of subject at baseline and after 21 days of twice-daily use of EltaMD Barrier Renewal Complex.

Sub.31. Subject shows a statistically significant improvement in skin smoothness and skin tone. Unretouched photographs of subject at baseline and after 21 days of twice-daily use of EltaMD Barrier Renewal Complex.

Sub. 5. Subject shows a statistically significant improvement in reduction of pore size, compared with baseline. Unretouched photographs of subject at baseline and after 21 days of twice-daily use of EltaMD Barrier Renewal Complex.

Clinical study on file.

ACKNOWLEDGEMENTSStephens and Associates Denver, CO.

This study was sponsored in full by EltaMD Skin Care, a division of Swiss-American©2016

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Dry skin may be induced by one or more factors such as low humidity, low environmental temperature, aging, psychological stress, microorganisms, and/or exposure to chemicals. Use of moisturizers to combat symptoms of dry skin are often the first treatment option to increase skin hydration. Unfortunately, the dry skin transepidermal water loss can induce inflammatory cytokine release and subsequent inflammatory cell infiltrate. These complex interactions can then lead to additional inflammation and hyperproliferation. This inflammation cannot be resolved simply by adding moisture to the stratum corneum.

A moisturizer that can hydrate, provide penetrating lipid profiles (e.g. ceramides and fatty acids) and ingredients that decrease inflammation was hypothesized to resolve dry skin symptoms and associated inflammation more quickly than a leading dermatologist recommended ceramide containing moisturizer. The test moisturizer was developed and tested in double blind kinetic and usage clinical studies compared to controls. Skin appearance, moisturization, smoothness, tone, pore size, flakiness, elasticity and skin barrier function were assessed in 32 female subjects (15 test: 17 control) with dry or combination facial skin using both objective and subjective measurements.

DOUBLE BLIND RANDOMIZED CLINICAL STUDY ON SKIN TEXTURE IMPROVEMENTWITH SPECIALIZED MOISTURIZERS

Melanie C. Timms¹ , Laura K. S. Parnell, BS, MSc²Swiss‐American Products, Inc. Carrollton, TX¹; Precision Consulting, Missouri City, TX

As expected, both products had significant improvements in hydration and skin dryness in as little as 4 hours and 24 hours following a single application as well as during the 3 week study period. Significant improvements in TEWL, skin tone, fine flakes, coarse flakes desquamation index values were also seen for both products. However, significant improvements in extensibility, pure elasticity and biological elasticity measurement over a 24 hour period were only observed for the test product group. The test product also significantly reduced pore size in as little as one week and throughout the entire study. The control moisturizer was statistically outperformed for pore size and visible smoothness. Within 21 days, 100% of test product subjects had significant visible and tactile smoothness improvements.

Use of a moisturizer containing multiple ingredients that target key deficiencies can improve skin texture and appearance. Breaking the dry skin cycle may be of use in maintaining healthy skin and improving compromised skin quickly.

Abstract

Acknowledgments & Disclosures

Study Conducted by Thomas J. Stephens & Associates, Inc., Richardson, Texas and Colorado Springs, Colorado

Study funding sponsored in full by Swiss-American Products, Inc. (Carrollton, Texas)

Introduction

Dry skin is characterized by a lack of either lipids, water or both, resulting in tightness, flaking and inflammation. Skin may appear dull, especially on the cheeks and around the eyes. It may lack elasticity, presenting accentuated fine lines and wrinkles. In more severe cases, itching and burning may occur. Dry skin can be genetically determined or triggered by external factors such as UV exposure, environment, cosmetics, or medications. It can also be a natural consequence of the aging process, as sebum production slows down.

8-625 Rev. 3/16

EltaMD

® Barrier Renewal Com

plex is clinically proven to moisturize the stratum

corneum and

improve dry, com

promised skin in just 24 hours after a single application.

Sub. 1.Subject shows a statistically significant im

provement in skin barrier function

as measured by a decrease in transepiderm

al water loss, com

pared to untreated skin. U

nretouched photographs of subject at baseline and after 21 days of twice-daily use

of EltaMD Barrier Renew

al Com

plex.

Sub. 21.Subject shows a statistically significant im

provement in skin

elasticity.U

nretouched photographs of subject at baseline and after 21 days of twice-daily

use of EltaMD Barrier Renew

al Com

plex.

Sub.31.Subject shows a statistically significant im

provement in skin sm

oothness and skin tone. U

nretouched photographs of subject at baseline and after 21 days of tw

ice-daily use of EltaMD Barrier Renew

al Com

plex.

Sub. 5.Subject shows a statistically significant im

provement in reduction of

pore size, compared w

ith baseline. Unretouched photographs of subject at baselineand after 21 days of tw

ice-daily use of EltaMD Barrier Renew

al Com

plex.

Clinical study on file.

ACKN

OW

LEDG

EMEN

TSStephens and Associates Denver, C

O.

This study was sponsored

in full by EltaMD Skin C

are, a division of Sw

iss-American

©2016

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The objective of this study was to measure a facial moisturizer that can hydrate, provide penetrating lipid profiles (e.g. ceramides and fatty acids) and ingredients that decrease inflammation to resolve dry skin symptoms and associated inflammation more quickly than a commercially available recommended ceramide containing moisturizer.

Objective

A statistically significant improvement in extensibility, pure elasticity and biological elasticity measurements over a 24 hour period were only observed for the test product group.

Comparisons between the test materials indicated that the test moisturizer outperformed the control, a leading ceramide-containing moisturizer, for improving visual smoothness at weeks 1 and 3, evenness of skin tone at weeks 2 and 3, and pore size at week 3.

Within 21 days, 100% of test product subjects had significant visible and tactile smoothness improvements.

Both moisturizers were tolerated well by the study panel throughout the three-week study period.

Conclusions

As seen in Table 1:

• Within 21 days, 100% of subjects had visibleand tactile smoothness in subjects using thetest product.

*Significant improvements in visible and tactilesmoothness in as little as one week and throughoutstudy for both products. See Figure 1.

*The test product significantly outperformed controlfor visible smoothness (p=0.04). See Figure 1.

• Significant improvements in moisturizing andskin dryness

*In as little as 4 hours and even after 24 hoursfollowing a single application for both products

*During entire 3 week study period for both products

• Significant reduction in pore size within oneweek and maintained throughout the entire studywith test product. See Figure 3.

*The test product outperformed control for pore sizereduction (p=0.04).

• Significant improvements in extensibility, pureelasticity and biological elasticity measurementover 24 hour period in test product subjects.

• Within one week, both products had significantimprovements in Skin tone, TEWL values, Fineand coarse flakes, Desquamation index. Figure 2

As seen in Figure 1, tactile and visual smoothness was improved and was statistically significantly improved for the test and control products.

As seen in Figure 2, skin smoothness and skin tone is improved over 3 weeks of twice daily usage.

As seen in Figure 3, pore size was visually and statisti-cally reduced over the study.

Statistically significant compared to Baseline * p<0.05

Statistically significant compared to Baseline ^ p<0.001Statistically significant compared between moisturizers # p=0.04

Results

Leveque, J. L., et al. “Biophysical characterization of dry facial skin.” J Soc Cosmet Chem 82 (1987): 171-177.

Byrne, A. J. “Bioengineering and subjective approaches to the clinical evaluation of dry skin.” International journal of cosmetic science 32.6 (2010): 410-421.

Hashizume, Hideo. “Skin aging and dry skin.” The Journal of dermatology 31.8 (2004): 603-609.

Rawlings, A. V., and C. R. Harding. “Moisturization and skin barrier function.” Dermatologic therapy 17.s1 (2004): 43-48.

References

This single-center, randomized, evaluator-blinded, controlled clinical trial was conducted to assess the efficacy and tolerance of the test moisturizer compared to a commercially available control moisturizer after a single application on the leg and twice daily for 3 weeks on the face.

A total of 32 female subjects aged 32 to 65 (mean age=50.3), with dry or combination facial skin completed the 3-week usage study and 16 subjects completed the 24-hour kinetic study. Subjects applied the assigned test or control moisturizer to the entire face twice per day.

Objective and subjective tolerance and clinical efficacy evaluations were performed by an expert grader at baseline, post-application, week 1, week 2 and week 3 of product use. Parameters assessed by an expert grader included tactile smoothness, visual smoothness, evenness of skin tone and pore size.

Bioinstrumentation measurements were taken at each time point using corneometer, cutometer, tewameter, D-squame discollection. Digital photography was also included in the study.

Methods

Fig. 2 Smoothness and Tone ImprovementCross-Polarized Front View; Test Subject

Sub31-C174: baseline Sub31-C174: week 3

Fig. 1 Smoothness Improvement vs. Baseline Table 1 Percent ImprovementFrom Baseline by Group

Fig. 3 Pore Size Reduction Improvement vs. Baseline

120

* **

100 100%

80

60

40

20

0

0

10

20

30

40

50

60

70

Perc

ent

Perc

ent

Baseline Week 1 Week 2 Week 3

Baseline Week 1 Week 2 Week 3

Test Control

** *

#

Measurement

Measurement 100.0%Visual Smoothness 82.4%Hydration 64.7%Pore Size 35.3%Coarse Flakes 58.8%

100.0%100.0%85.7%71.4%71.4%

TestMoisturizer

ControlMoisturizer

##

Tactile Test Visual Test Tactile Control Visual Control