formulator report: exfoliating facial scrub with ...the test articles containing either 6%...

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1. Final Reports available upon request. Figures can be found on the next two pages of this document. 2. Compliant with all current microplastic bead legislation. Clinical Study Facts 1 : In double-blind, controlled, bioinstrumental studies, Ecobeads in an exfoliating facial scrub provided the following benefits when compared to other exfoliating beads: Effective exfoliation as quantified by a reduction of dihydroxyacetone-induced skin color and improvement in skin scaliness (indication of desquamation) (Figures 1 and 2) Less disruption of skin barrier function as measured by transepidermal water loss (TEWL) (Figure 3) Less diffuse facial redness (Figures 4 and 5) Less erythema (i.e. redness) (Figure 6) Ecobeads (<1000 microns) Polyethylene (<840 microns) Apricot Shells (100-200 microns) www.floratech.com ® Ecobeads provide effective exfoliation without causing damage to the skin (i.e. skin barrier disruption or erythema), resulting in an effective yet gentle finished product that is preferred by consumers over polyethylene beads. Ecobeads [INCI: Stearyl Stearate (and) Euphorbia Cerifera (Candelilla) Wax (and) Jojoba Esters] are botanically-derived beads that can be used in exfoliating formulas as an alternative to polyethylene beads or to harsh natural exfoliants that often have sharp, jagged edges. Mechanical exfoliation can often lead to an increase in skin redness and barrier disfunction as a result of irritation caused by the rough surface of exfoliants. The images below demonstrate the smooth surface of Ecobeads as compared to the rougher edges of other common exfoliants (magnified under 40x). Formulator Report: Exfoliating Facial Scrub with Biodegradable Ecobeads ® Revision Date: February 2016 FR-007 © Copyright 2015, 2016 International Flora Technologies, Ltd., All Rights Reserved Floratech Proprietary & Confidential In a double-blind, consumer-use study, consumers indicated preference for an exfoliating facial scrub containing Ecobeads over polyethylene beads for the following attributes (Figure 7): Overall product performance Gentleness Spreadability Texture and consistency Refreshed appearance of skin Smoothness of skin Softness of skin Less irritation Formulation Benefits: Biodegradable Botanically-derived Available in a wide variety of colors Microplastic-free 2

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Page 1: Formulator Report: Exfoliating Facial Scrub with ...the test articles containing either 6% polyethylene particles or 6% apricot shells each produced statistically significant (p

1. Final Reports available upon request. Figures can be found on the next two pages of this document.

2. Compliant with all current microplastic bead legislation.

Clinical Study Facts1:In double-blind, controlled, bioinstrumental studies, Ecobeads in an exfoliating facial scrub provided the following benefits when compared to other exfoliating beads:• Effective exfoliation as quantified by a reduction

of dihydroxyacetone-induced skin color and improvement in skin scaliness (indication of desquamation) (Figures 1 and 2)

• Less disruption of skin barrier function as measured by transepidermal water loss (TEWL) (Figure 3)

• Less diffuse facial redness (Figures 4 and 5)• Less erythema (i.e. redness) (Figure 6)

Ecobeads(<1000 microns)

Polyethylene(<840 microns)

Apricot Shells(100-200 microns)

www.floratech.com

®

Ecobeads provide effective exfoliation without causing damage to the skin (i.e. skin barrier disruption or erythema), resulting in an effective yet gentle finished product that is preferred by consumers over polyethylene beads.

Ecobeads [INCI: Stearyl Stearate (and) Euphorbia Cerifera (Candelilla) Wax (and) Jojoba Esters] are botanically-derived beads that can be used in exfoliating formulas as an alternative to polyethylene beads or to harsh natural exfoliants that often have sharp, jagged edges. Mechanical exfoliation can often lead to an increase in skin redness and barrier disfunction as a result of irritation caused by the rough surface of exfoliants. The images below demonstrate the smooth surface of Ecobeads as compared to the rougher edges of other common exfoliants (magnified under 40x).

Formulator Report:Exfoliating Facial Scrub withBiodegradable Ecobeads®

Revision Date: February 2016 FR-007© Copyright 2015, 2016 International Flora Technologies, Ltd., All Rights Reserved Floratech Proprietary & Confidential

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In a double-blind, consumer-use study, consumers indicated preference for an exfoliating facial scrub containing Ecobeads over polyethylene beads for the following attributes (Figure 7): • Overall product performance • Gentleness • Spreadability• Texture and consistency• Refreshed appearance of skin • Smoothness of skin• Softness of skin• Less irritation

Formulation Benefits:• Biodegradable• Botanically-derived• Available in a wide variety of colors• Microplastic-free2

Page 2: Formulator Report: Exfoliating Facial Scrub with ...the test articles containing either 6% polyethylene particles or 6% apricot shells each produced statistically significant (p

Figures3:

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Ecobeads Provided Efficient Exfoliation

Ecobeads Did Not Disrupt Skin Barrier Function

Ecobeads Reduced Skin Scaliness

Figure 1: All test articles produced statistically significant (p<0.05) reductions in color at all evaluation time points. The test articles containing 6% Ecobeads and 6% polyethylene particles produced statistically significantly (p<0.05) higher percent decreases in skin color than the control (water) at Day 4. (See Claim Sheet 15-061.)

Figure 3: The test article containing 6% Ecobeads did not produce a statistically significant reduction in skin barrier function (i.e. increase in TEWL) over baseline or the vehicle; whereas the test articles containing either 6% polyethylene particles or 6% apricot shells each produced statistically significant (p<0.01) reductions in skin barrier function. The test article containing 6% polyethylene particles also resulted in statistically significantly (p<0.05) larger reductions in skin barrier function than the vehicle. (See Claim Sheet 15-063.)

Figure 2: Test articles containing 6% Ecobeads and 6% polyethylene particles produced statistically significant decreases (p<0.05) in skin scaliness at Days 4 and 5. (See Claim Sheet 15-061.)

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3. All studies were conducted double-blind, vehicle-controlled, and randomized.

Revision Date: February 2016 FR-007© Copyright 2015, 2016 International Flora Technologies, Ltd., All Rights Reserved Floratech Proprietary & Confidential

D vehicle + 6% apricot shells

C vehicle + 6% polyethylene

B vehicle + 6% Ecobeads

A vehicle

Legend for Figures 1 and 2:

D control (water)C vehicle + 6% apricot shells B vehicle + 6% polyethylene A vehicle + 6% Ecobeads

Page 3: Formulator Report: Exfoliating Facial Scrub with ...the test articles containing either 6% polyethylene particles or 6% apricot shells each produced statistically significant (p

Ecobeads Did Not Increase Erythema (Redness)

Ecobeads Produce Less Diffuse Facial Redness

vehicle + 6% Ecobeads (normal)

vehicle + 6% Ecobeads (diffuse redness highlighted)

vehicle + 6% polyethylene (normal)

vehicle + 6% polyethylene (diffuse redness highlighted)

Figures 4 and 5: The test article containing 6% polyethylene particles produced statistically significant (p<0.01) increases in diffuse facial redness immediately post-exfoliation. Ecobeads did not produce a significant increase in diffuse redness over baseline. (See Claim Sheet 15-064.)

Figure 6: The test articles containing either 6% polyethylene particles or 6% apricot shells each produced statistically significant (p<0.001) increases in erythema immediately and 30 minutes post-exfoliation (from baseline), as well as relative to the vehicle. Ecobeads did not produce a statistically significant increase in erythema over baseline, nor did it cause a significant increase in erythema relative to the vehicle. (See Claim Sheet 15-062.)

Figure 7: Although subjects indicated polyethylene particles as more effectively exfoliating, they also indicated a preference for Ecobeads for all categories that would be a result of effective exfoliation (e.g. refreshed skin appearance, smoothness of skin, softness of skin). Ecobeads were also viewed as milder to the skin (i.e. gentleness and less irritation). Statistical (**) and directional (*) significance was apparent where indicated (p<0.05 and p<0.10, respectively). (See Claim Sheet 15-065.)

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Smoothness of Skin

Less Irritation**

Refreshed Appearance of Skin Texture/Consistency**

E�ectively Exfoliates*

Spreadability**

Gentleness**

Overall Product Performance

Revision Date: February 2016 FR-007© Copyright 2015, 2016 International Flora Technologies, Ltd., All Rights Reserved Floratech Proprietary & Confidential

Ecobeads were Preferred by Consumers

D vehicle + 6% apricot shells C vehicle + 6% polyethylene B vehicle + 6% Ecobeads A vehicle

Immediate Post-Exfoliation

Percent Change in Diffuse Facial Redness

from Baseline

vehicle + 6% Ecobeads 0.4%

vehicle + 6% polyethylene 5.1%

vehicle + 6% polyethylene vehicle + 6% Ecobeads

Page 4: Formulator Report: Exfoliating Facial Scrub with ...the test articles containing either 6% polyethylene particles or 6% apricot shells each produced statistically significant (p

Formula Properties: Property ResultpH 4 - 6Viscosity 302 - 964 kcP

Ingredient Information 24/7 Online

®

www.floratech.com/info

Procedure:1. Add the Versene Na2 Crystals to the deionized water with moderate propeller agitation and mix until completely dissolved. 2. While heating to 75-80oC, add the remaining ingredients of Phase A in the order listed with moderate propeller agitation.3. In a separate vessel, mix all ingredients of Phase B. While heating to 75-80oC, mix with moderate propeller agitation until

uniform.4. Add Phase B to Phase A with rapid propeller agitation at 75-80oC. 5. Add Phase C to Phase AB with rapid propeller agitation at 75-80oC to achieve pH 6.5-7.5.6. Cool Phase ABC to 45-50oC.7. Add Phase D to Phase ABC with moderate propeller agitation at 45-50oC to achieve pH 4.8-5.0.8. Add Phase E to Phase ABCD at 40-45oC and cool to room temperature.9. Add Phase F when the batch has cooled to room temperature.

Phase Trade/Common Name INCI Name Manufacturer % wt./wt.A Deionized Water Water ----- q.s.

Versene® Na2 Crystals Disodium EDTA The Dow Chemical Co. 0.05

1,3-Butylene Glycol Butylene Glycol Celanese Chemicals 2.00

Sulfochem® EA-2 Surfactant Ammonium Laureth Sulfate Essential Ingredients 14.50

Chembetaine® C Surfactant Cocamidopropyl Betaine The Lubrizol Corporation 13.00

Glucamate® DOE-120 PEG-120 Methyl Glucose Dioleate The Lubrizol Corporation 2.00

B Hallstar TAB-2V Distearyl Phthalic Acid Amide The HallStar Company 4.50

Lanette® 16 Cetyl Alcohol BASF Corporation 4.00

Vegarol® 1898 Stearyl Alcohol Essential Ingredients 4.00

C Sodium Hydroxide, ACS Grade (15% Solution) Sodium Hydroxide (and) Water VWR International LLC q.s.

D Citric Acid, USP (30% Solution) Citric Acid (and) Water Archer Daniels Midland Company q.s.

E Phenonip® Phenoxyethanol (and) Methylparaben (and) Ethylparaben (and) Butylparaben (and) Propylparaben (and) Isobutylparaben

Clariant Corporation q.s.

F Ecobeads5 Stearyl Stearate (and) Euphorbia Cerifera (Candelilla) Wax (and) Jojoba Esters

Floratech 6.00

Total 100.00

Formula: Gentle Face Scrub with Biodegradable Ecobeads4

This facial scrub featuring Ecobeads gently exfoliates, leaving the skin feeling smooth and refreshed. Ecobeads are low-cost, biodegradable scrubbing beads made of natural waxes that are proven to exfoliate as effectively as polyethylene. Additionally, due to their spherical shape Ecobeads are gentler than polyethylene and other natural exfoliatives, and therefore result in less erythema and barrier disruption during exfoliation. Ecobeads are available in many colors and are ideal for formulators seeking a natural biodegradable exfoliative positioned for value.

4. INCI/Trade names must be verified with each manufacturer.

5. Any color or combination of colors may be used.

Revision Date: February 2016 FR-007© Copyright 2015, 2016 International Flora Technologies, Ltd., All Rights Reserved Floratech Proprietary & Confidential

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