Technical Report: Gentle Face Scrub with Biodegradable ... · Gentle Face Scrub with Biodegradable Ecobeads ® Technical Report: Summary of Results: Under the conditions of the study,

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TR-027Floratech Proprietary & Confidential

Technical Report:

Revision Date: November 2015© Copyright 2015, International Flora Technologies, Ltd., All Rights Reserved

Gentle Face Scrub with Biodegradable Ecobeads®

Synopsis:Plastic microbeads (i.e. polyethylene particles) have recently come under scrutiny for their lack of biodegradability and propensity to bioaccumulate in aquatic ecosystems. Several large personal care companies have made it a priority to remove polyethylene particles from all of their facial scrubs, body washes, toothpastes, and other personal care products. Additionally, several American states and OECD member countries have prepared legislation to ban the use of plastic microbeads in cosmetic and personal products. These particles often provide exfoliation properties and visual aesthetics to such products, and must be tolerant of the surfactant-heavy nature of such formulations. A series of clinical studies were performed to evaluate more eco-friendly alternatives to polyethylene particles. When multiple particles were compared, it was found that polyethylene-free alternatives also possess exfoliating properties. Furthermore, it was demonstrated that Ecobeads were less irritating to the skin than more jagged particles, hence providing a more pleasurable consumer experience. This technical report confirms that there is a natural and biodegradable solution to the increasing demand for finished product manufacturers to be more environmentally conscious without losing functionality.Description of Ecobeads: Ecobeads [INCI: Stearyl Stearate (and) Euphorbia Cerifera (Candelilla) Wax (and) Jojoba Esters] are biodegradable, 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. Additionally, this breakdown in the barrier can leave the skin more susceptible to contaminants such as allergens and toxins. Polyethylene-Free Exfoliants:The images below illustrate the surfaces of the exfoliants evaluated within this study (magnified under 60x).

M - Copernicia Cerifera (Carnauba) Wax (and) Beeswax

N - Synthetic WaxL - Polylactic Acid PowderK - Cellulose

J - Bambusa Arundinacea Stem Extract

I - Hydrogenated Castor OilH - Microcrystalline Cellulose (and) Hydroxypropylcellulose (and)

Panthenyl Triacetate

G - Polylactide Resin PLAF - Hydrogenated Castor Oil (and) Hydrogenated Jojoba Oil

B - Florabeads Jojoba White (Natural)

A - Ecobeads Natural C - Florabeads Rice Bran Wax Natural

D - Florabeads Carnauba Natural

E - Metabeads Microwax White (Natural)

O - Hydrogenated Jojoba Oil

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Technical Report:

Exfoliant Composition(INCI)

Particle Size

(microns)

Melting Point(oC)

Lack of Irritation ExfoliationBarrier

Function3 Erythema3 ΔE4

A - Ecobeads® Natural[Floratech]

Stearyl Stearate (and) Euphorbia Cerifera

(Candelilla) Wax (and) Jojoba Esters

<1,000 55-651 X X X

B - Florabeads® Jojoba White(Natural)

[Floratech]Jojoba Esters 250-600 66-711 X X X

C - Florabeads Rice Bran WaxNatural

[Floratech]

Oryza Sativa (Rice) Bran Wax 250-600 70-831 X X X

D- Florabeads Carnauba Natural[Floratech]

Copernicia Cerifera (Carnauba) Wax 250-600 75-821 X X X

E - Metabeads® Microwax White(Natural)

[Floratech]Microcrystalline Wax 250-600 87-951 X X X

FHydrogenated Castor Oil

(and) Hydrogenated Jojoba Oil

425-850 82-901 X X

G Polylactide Resin PLA 630 (avg) 150+2 X

HMicrocrystalline Cellulose

(and) Hydroxypropylcellulose (and) Panthenyl Triacetate

200-400 N/A X X

I Hydrogenated Castor Oil 500 (avg) 79-851 X X

J Bambusa Arundinacea Stem Extract 50-100 N/A X

K Cellulose 200-300 N/A X

L Polylactic Acid Powder 150 (max) 140-1501 X

MCopernicia Cerifera

(Carnauba) Wax (and) Beeswax

840 (max) 71-771 X X

N Synthetic Wax 180-420 108-1131 X XO Hydrogenated Jojoba Oil 150-850 68-702 X X

Polyethylene-Free Exfoliants:Table 1 provides a list of each exfoliant that was evaluated within this study, as well as a brief summary of the clinical results.Table 1


1. Obtained from product manufacturer specifications.2. Evaluated in the Floratech lab.3. Did not result in a statistically (p<0.05) or directionally (p<0.10) significant increase from baseline at any time evaluation point.4. Exfoliated statistically significantly (p<0.05) better than the vehicle at the Day 5 time evaluation point.

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Technical Report:

Clinical Study: Changes in Skin Barrier Function and Erythema

Methodology:Each of the exfoliants listed within Table 1 were incorporated into the exfoliating face scrub (see page 7) at a loading level of 6%, and evaluated for changes in skin barrier function and erythema (redness). Each site was exfoliated twice with the corresponding exfoliating facial scrub. Skin redness (via Mexameter) measurements were taken at baseline, immediately post-exfoliation, and 30 minutes post-exfoliation. Transepidermal water loss (TEWL) measurements (via Tewameter) were taken at baseline and 30 minutes post-exfoliation. Positive results were quantified by a lack of an increase in erythema and TEWL. All study procedures were double-blind and randomized.Materials:Mexameter MX18 and Tewameter TM300 are products of Courage+Khazaka (Köln, Germany). Subjects:Figures 1 and 2: 34 male and female subjects 22-55 years of ageResults:

0%

5%

10%

15%

20%

25%

30 Minutes

Evaluation Time Point (Post-Exfoliation)

% C

hang

e in

TEW

L

AB C D E F

G

H

I

JK

L

M

PO

N

Figure 1. Change in TEWL


Exfoliants provided by Floratech

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P - VehicleO - Hydrogenated Jojoba OilN - Synthetic WaxM - Copernicia Cerifera (Carnauba) Wax (and) BeeswaxL - Polylactic Acid PowderK - CelluloseJ - Bambusa Arundinacea Stem ExtractI - Hydrogenated Castor Oil

H - Microcrystalline Cellulose (and) Hydroxypropylcellulose (and) Panthenyl Triacetate

G - Polylactide Resin PLA

F - Hydrogenated Castor Oil (and) Hydrogenated Jojoba Oil

E - Metabeads Microwax White (Natural)D - Florabeads Carnauba NaturalC - Florabeads Rice Bran Wax NaturalB - Florabeads Jojoba White (Natural)A - Ecobeads Natural


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Technical Report:

Figure 2. Change in Erythema

Summary of Results: Under the conditions of the study, Ecobeads Natural (A), Florabeads Jojoba White (Natural) (B), Florabeads Rice Bran Wax Natural (C), Florabeads Carnauba Natural (D), Metabeads Microwax White (Natural) (E), Hydrogenated Castor Oil (and) Hydrogenated Jojoba Oil (F), Hydrogenated Castor Oil (I), Copernicia Cerifera (Carnauba) Wax (and) Beeswax (M), Synthetic Wax (N), Hydrogenated Jojoba Oil (O), and the Vehicle (P) did not produce significant increases in erythema or significant decreases in skin barrier function at any evaluation time point. Polylactide Resin PLA (G), Bambusa Arundinacea Stem Extract (J), and Polylactic Acid Powder (L) produced both statistically significant (p<0.05) increases in erythema immediately post-exfoliation, and statistically significant (p<0.05) decreases in skin barrier function 30 minutes post-exfoliation. Cellulose (K) produced a statistically significant (p<0.05) increase in erythema immediately post-exfoliation, but did not produce a statistically significant increase in TEWL 30 minutes post-exfoliation. Test Article Microcrystalline Cellulose (and) Hydroxypropylcellulose (and) Panthenyl Triacetate (H) produced a directionally significant (p<0.10) increase in erythema, however did not produce a statistically significant increase in TEWL.

5. There was not an increase in erythema.

0%

2%

4%

6%

8%

10%

30 MinutesImmediate

% In

crea

se in

Ery

them

a


A5 A5 B5B5 C5C5 D5D5 E5E5

F

F

G

G

H

H

I5I5

J

JK

K

L

L

M5M5

N

N5 O5O5 P5P5


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P - VehicleO - Hydrogenated Jojoba OilN - Synthetic WaxM - Copernicia Cerifera (Carnauba) Wax (and) BeeswaxL - Polylactic Acid PowderK - CelluloseJ - Bambusa Arundinacea Stem ExtractI - Hydrogenated Castor Oil


G - Polylactide Resin PLA


E - Metabeads Microwax White (Natural)D - Florabeads Carnauba NaturalC - Florabeads Rice Bran Wax NaturalB - Florabeads Jojoba White (Natural)A - Ecobeads Natural


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Technical Report:

Clinical Study: Exfoliation Efficacy - 1Methodology:The exfoliants listed within Table 1 were incorporated into the exfoliating face scrub (see page 7) at a loading level of 6%, and evaluated for exfoliation efficacy, as compared to the vehicle exfoliating face scrub (without exfoliants). On Days 1 and 2, skin was patched with dihydroxyacetone (DHA) to induce color. On Days 3, 4, and 5, each DHA-induced site was exfoliated twice with the corresponding exfoliating facial scrub. Skin color (L*a*b* via Colorimeter) measurements were taken at baseline (on Day 3 prior to exfoliation) and post-exfoliation (on Days 3, 4, and 5). Exfoliation was quantified by a change (i.e. reduction) in the color (ΔE6) produced by the DHA. All study procedures were double-blind and randomized.Materials:Colorimeter CL 400 is a product of Courage+Khazaka (Köln, Germany). Dihydroxyacetone (INCI: Dihydroxyacetone) was supplied by EMD Chemicals Inc. (Darmstadt, Germany).Subjects:Figure 3: 14 male and female subjects 23-51 years of age (backs)Results:

6. ΔE = √ [(L*2-L*1)2 +(a*2-a*1)

2 +(b*2-b*1)2]

1.0

1.5

2.0

2.5

3.0

3.5

4.0

Day 5Day 4Day 3


ΔE

J D

I

M N

O

C A G HBEK

P

K

B

D G

C J A

EI N

H

O M

P

Figure 3. Mean ΔE Values


Summary of Results: Under the conditions of the study, Ecobeads Natural (A), Florabeads Jojoba White (Natural) (B), Florabeads Rice Bran Wax Natural (C), Florabeads Carnauba Natural (D), Metabeads Microwax White (Natural) (E), Polylactide Resin PLA (G), Microcrystalline Cellulose (and) Hydroxypropylcellulose (and) Panthenyl Triacetate (H), and Cellulose (K) exfoliated better than the Vehicle (P) exfoliating face scrub, as measured by reduction in color (ΔE) produced by DHA (p<0.05).


P - VehicleO - Hydrogenated Jojoba OilN - Synthetic WaxM - Copernicia Cerifera (Carnauba) Wax (and) BeeswaxK - CelluloseJ - Bambusa Arundinacea Stem ExtractI - Hydrogenated Castor Oil


G - Polylactide Resin PLAE - Metabeads Microwax White (Natural)D - Florabeads Carnauba NaturalC - Florabeads Rice Bran Wax NaturalB - Florabeads Jojoba White (Natural)A - Ecobeads Natural

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Technical Report:

Summary of Results: Under the conditions of the study, Ecobeads Natural (A) and Polylactic Acid Powder (L) exfoliated statistically significantly (p<0.05) better than the Vehicle (P) exfoliating face scrub, as measured by reduction in color (ΔE) produced by DHA, on Days 4 and 5. Of the three exfoliants evaluated, Ecobeads Natural (A) was the only test article that produced statistically significant (p<0.05) decreases in skin roughness on Days 3, 4, and 5. Ecobeads Natural (A) also produced statistically significant (p<0.05) decreases in skin scaliness at all evaluation time points, while Polylactic Acid Powder (L) produced statistically significant (p<0.05) decreases in skin scaliness on Days 4 and 5.These studies demonstrate polyethylene-free exfoliant options that don’t result in a decrease in exfoliation efficacy.

Figure 5. Change in Skin Scaliness / Roughness


Figure 4. Mean ΔE Values

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Day 5Day 4Day 3Evaluation Time Point (Post-Exfoliation)

ΔE

A

A

P

P

L

L

F

F

-80%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

10%

20%

RoughnessScaliness

Perc

ent C

hang

e fr

om B

asel

ine

A AF FL

L

P P

Day 5 (Post-Exfoliation)

Methodology:The exfoliants listed within Table 1 were incorporated into the exfoliating face scrub (see page 7) at a loading level of 6%, and evaluated for exfoliation efficacy, as compared to the vehicle exfoliating face scrub (without exfoliants). On Days 1 and 2, skin was patched with dihydroxyacetone (DHA) to induce color. On Days 3, 4, and 5, each DHA-induced site was exfoliated twice with the corresponding exfoliating facial scrub. Skin color (L*a*b* via Colorimeter) and scaliness (SEsc) / roughness (SEr) measurements (via Visioscan) were taken at baseline (on Day 3 prior to exfoliation) and post-exfoliation (on Days 3, 4, and 5). Exfoliation was quantified by a change (i.e. reduction) in the color (ΔE) produced by the DHA and the reduction of scaliness (indication of desquamation) / roughness.All study procedures were double-blind and randomized.Materials:Colorimeter CL 400 and Visioscan VC98 are products of Courage+Khazaka (Köln, Germany). Dihydroxyacetone (INCI: Dihydroxyacetone) was supplied by EMD Chemicals Inc. (Darmstadt, Germany).Subjects:Figures 4 and 5: 15 female subjects 23-55 years of age (forearms)Results:

Clinical Study: Exfoliation Efficacy - 2

Exfoliant provided by Floratech Exfoliant provided by Floratech

P - Vehicle

F - Hydrogenated Castor Oil (and) Hydrogenated Jojoba OilL - Polylactic Acid Powder

A - Ecobeads

P - VehicleL - Polylactic Acid Powder


A - Ecobeads Natural

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Technical Report:

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.

Formula: Gentle Face Scrub with Biodegradable Ecobeads7

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

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 Ecobeads8 Stearyl Stearate (and) Euphorbia Cerifera (Candelilla) Wax (and) Jojoba Esters

Floratech 6.00

Total 100.00

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

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


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Technical Report:

Formula: Gentle Face Scrub Vehicle9

Stability: Evaluations were conducted under the following conditions• 4°C, 25°C (room temperature), 43°C with ambient humidity for 12 weeks• 50°C with ambient humidity for 2 weeks• Freeze/Thaw: Freeze at -18°C; product was frozen/thawed once per day for 3 consecutive days (i.e. cycles)• Ultraviolet Light: Room Temperature for 2 weeks• No Light: Room Temperature for 12 weeks

Methods: Samples were evaluated at room temperature for viscosity, color (visual), appearance, and odor right after production (week 0). Samples were removed from the stability chamber and brought to room temperature before each evaluation. Evaluations were conducted on the 1st, 2nd, 3rd, 4th, 8th, and 12th week of stability. Samples meeting the criteria were noted as “pass”. Passing indicates the product is stable and maintains acceptable viscosity, color, appearance, and odor.

Summary: The Gentle Face Scrub with Biodegradable Ecobeads was stable in various temperatures and conditions for 12 weeks, with the exception of 50°C and ultraviolet light conditions. Also, the viscosity after freeze/thaw testing was unchanged.

Test Stability Temp. Week 0 Week 1 Week 2 Week 3 Week 4 Week 8 Week 12

Viscosity

4°C pass pass pass pass pass pass25°C pass pass pass pass pass pass pass43°C pass pass pass pass pass pass50°C pass pass

Color-Visual

4°C pass pass pass pass pass pass25°C pass pass pass pass pass pass pass43°C pass pass pass pass pass pass50°C pass fail10

Appearance


Odor


No Light at Room Temperature pass pass pass pass pass passUltraviolet Light at Room Temperature pass fail10

Freeze/Thaw Cycles Cycle I Cycle II Cycle IIIViscosity pass pass pass

9. Stability was evaulated without exfoliants.

10. Failed due to a color change (yellow) in the vehicle formula.


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Technical Report: Gentle Face Scrub with Biodegradable ... · Gentle Face Scrub with Biodegradable Ecobeads ® Technical Report: Summary of Results: Under the conditions of the study,