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sensiva ® SC 50 Guidelines for formulating sensiva ® SC 50 into emulsions

sensiva SC 50 · This is between typical HLB values of emulsifier ... • increase the HLB of the emulsifier system by changing the ratio of emulsifiers • HLB (sensiva® SC 50

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sensiva® SC 50Guidelines for formulating sensiva® SC 50 into emulsions

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All results and some frame formulations published in this guideline were developed by cooperation with Gova Ingredients Research & Trading. Special thanks to Patrick Gonry and Elisabeth Hannet for the excellent collaboration and all their advice during this project.

Table of contents

Acknowledgement 2

1 Introduction 3

2 General aspects for formulating emulsions 3

2.1 Necessary ingredients in emulsions 3

2.2 Viscosity of emulsions 4

3 Formulating sensiva® SC 50 into emulsions 4

3.1 Method of incorporation 4

4 sensiva® SC 50 in W/O emulsions 5

4.1 To avoid water separation 5

5 sensiva® SC 50 in O/W emulsions 7

5.1 To avoid oil separation 7

5.2 Effect on viscosity 7

6 Frame Formulations 8

6.1 schülke KoKo test 8

6.2 W/O emulsions with sensiva® SC 50 Ref N° 586/062 9

6.3 O/W emulsion with sensiva® SC 50 and medium polar oils Ref N° 586/171 PO 10

6.4 O/W emulsion with sensiva® SC 50 and polar oils Ref N° 586/171 SO 11

6.5 O/W emulsion with sensiva® SC 50 and vegetable oils Ref N° 586/171 NO 12

6.6 Nappy rash cream Ref N° 559/147 13

6.7 O/W cream with sensiva® SC 50 Ref N° 571/088 14

6.8 Protective cream for very dry skin Ref N° 559/141 B 15

Acknowledgement

Two major concerns when formulating emulsions are stability and viscosity. Emulsions are thermodynamically unstable sys-tems. Aggregation followed by creaming, sedimentation, and coalescence, all work against the stability of an emulsion and can lead to the break down of the emulsion. Countering these instability phenomena as effectively as possible is an impor-tant step in formulating emulsions.Depending on emulsion type, different kinds of instability can be observed, such as water or oil separation or creaming. Creaming can be observed as the formation of a transparent phase at the bottom with a white emulsion on the top. This often precedes oil separation. sensiva® SC 50 in general does not cause creaming of cosmetic emulsions.

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Basic W/O emulsion Basic O/W emulsion

Observation Reason Observation Reason

Water separation at the bottom

• thetype/concentrationofemulsifier• thetype/concentrationofsalt• thetype/concentrationofpolyol• presenceofincompatibleingredients• homogenisationconditions(time,

force)• theamountofwater(toohigh)• theamountofoil(toohigh)

Creaming there is not sufficient structure in the water phase to prevent the lighter oil droplets to move upwards

Oil separation on the top • thenetworkstructureintheoilphaseis not well adapted to the oil

• oilsarenotcompatible

Oil separation • thereisnotenoughemulsifier• theHLBoftheemulsifierdoesnot

match the required HLB of the oils• oneormoreoilsarenotsolublein

the oil phase. They separate from the emulsion

2 General aspects for formulating emulsions

2.1 Necessary ingredients in emulsions

Emulsion stability is linked closely to the right selection of emulsifying agents, the other ingredients and the homogenisa-tion process. To select the right emulsifying system, the hydrophilic-lipophilic-balance (HLB) should be considered. The HLB valuerelatestothehydrophilicandlipophilicpropertiesofanemulsifierandisafirstindicationoftheappropriatechoiceofanemulsifiersystem.Typically,water-in-oil(W/O)emulsifiershaveHLBvaluesintherangeof3–6,whileoil-in-water(O/W)emulsifiersareintherangeof8–14.SystemswithlowerHLBwilltendtoformW/OemulsionsandsystemswithhigherHLBwill tend to form O/W emulsions.

sensiva® SC 50 is a multifunctional additive for cosmetic and personal care products. Its unique properties allow it to be used in a wide variety of different types of cosmetic products; such as deodorants, sun care products, baby care products and face creams. However, due to its surfactant-like structure it can have an influence on the stability and/or viscosity of emulsions.These guidelines can be used for formulating emulsions in general, as well as when using sensiva® SC 50.

1 Introduction

sensiva® SC 50 can have an influence on stability and/or viscosity due to its surfactant-like molecular structure. This structure can impact the HLB of an emulsion. sensiva® SC 50 has a calculated HLB of approximately 7.5. This is between typical HLB valuesofemulsifiersystemsforW/OandthoseforO/Wemulsions.The incorporation of sensiva® SC 50 into a formulation can cause a shift toward the opposite emulsion type, causing a poten-tial instability. A number of W/O and O/W emulsions were made incorporating 3 % sensiva® SC 50 to simulate the problems that can occur and therefore determine suitable corrective measures.

The stability of emulsions is not influenced by the method of incorporating sensiva® SC 50. It can be added to the oil phase, tothewaterphase,orafteremulsification.sensiva®SC50hasacalculatedeffectonstabilityatroomtemperature.Theinflu-ence on stability is most commonly noticeable at elevated temperatures (> 40 °C).Some ingredients may increase the risk of destabilisation of either W/O emulsions or both kinds of emulsions e. g.:

The best means of incorporation of sensiva® SC 50 should be evaluated for each individual formulation.

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W/O emulsions O/W emulsions

• increaseamountofwaterphase• additionofzincstearate,magnesiumstearate• increaseamountofemulsifier(causingadecreaseofdropletsize)• additionofwaxes• increaseamountofwaxes• combiningwaxes

• increaseamountofoilphase•decreasetheHLBoftheemulsifiersystems•increaseamountofemulsifier(causingadecreaseofdropletsize)•additionofwaxes•increaseamountofwaxes•combiningwaxes•additionoffattyalcohols,glycerylstearate•additionofanti-creamingagents

The viscosity of a cosmetic emulsion affects the form of the product (cream or lotion), the sensory properties and the release of actives from the emulsion. Different methods are used to increase the viscosity of systems depending on the type of emulsion being formed.

3 Formulating sensiva® SC 50 into emulsions

W/O emulsion O/W emulsion

Emulsifiersystem • twoemulsifierswithdifferentHLBintherangeof3–6

• emulsifiersshouldhavedifferentsolubility in oil

This forms a flexible but strong emulsifier coat. Emulsifier with lower HLB are too soluble in oil to diffuse to the interface. A higher HLB emulsi-fier tends to form O/W emulsions.

Emulsifiersystem • twoemulsifierswithdifferentHLBintherangeof8–14

• emulsifiersshouldhavedifferentsolubility in oil.

This forms a flexible but strong emulsifier coat. A lower HLB emulsifier is too soluble in oil to diffuse to the interface. A higher HLB emulsifier tends to be too soluble in the water phase

Electrolytes (MgSO4, NaCl)

• toreducethesolubilityoftheemulsi-fierinwater

Anti-creaming agent (rheo-logymodifiere.g.carbomer,xanthan gum, …)

• to form a network structure into the water that prevents the oil droplets

moving upwards.

Oil has a lower density than the surrounding water and tends to migrate upwards.

Polyols (glycerin,…) • topreventwaterlossandfreezing Polyols (glycerin,…) • topreventwaterlossandfreezing

Waxes (candelilla wax,…) • toformanetworkstructure in the oil phase

Co-stabiliser (fatty alcohol, gly-ceryl stearate, stearic acid,…)

• tostabilisetheemulsifiercoat

•essentialoils• sunscreens

•electrolytes(+>++>+++)(W/Oemulsions)•highlypolaroils

2 General aspects for formulating emulsions

2.2 Viscosity of emulsions

3.1 Method of incorporation

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sensiva® SC 50 has a minimal effect on stability (< 1 month at 40 °C)

Possible solutions: • increase the amount of salt • sensiva®SC50increasesthesolubility/dispersabilityoftheemulsifierinwater. Byincreasingthesalt,thesolubilityoftheemulsifierinwaterisdecreased. • decreasetheHLBoftheemulsifiersystembychangingtheratioofemulsifiers • HLB(sensiva®SC50+InitialEmulsifiers) > HLBInitialEmulsifier • combination of the solutions above

sensiva® SC 50 has a moderate effect on stability (< 2 weeks at 40 °C)

Possible solutions: • combination of minimal effect solutions • increasetheamountofmainemulsifier • sensiva®SC50affectstheemulsioninterface.Whentheamountofmainemulsifier is increased, the interface is stronger and sensiva® SC 50 is less destabilising. • changeoftheco-emulsifier • Chooseaco-emulsifierwithadifferentsolubility. Recommendedco-emulsifiers:sorbitanoleate,polyglyceryl-4isostearate. • combination of the solutions above

sensiva® SC 50 has a dramatic effect on stability (< 1 week at 40 °C)

Possible solutions: • combination of moderate effect solutions • substituteapolymericemulsifier(e.g.PEG-30dipolyhydroxystearate)fortheco-emulsifier •PolymericemulsifiersarequiteHLBindependent.TheincreaseinHLBcausedby sensiva® SC 50 will not destabilise the emulsion. •Polymericemulsifierspreventtheagglomerationofthedispersedphasebystericshielding. • combination of the solutions above If sensiva® SC 50 has a dramatic effect on stability, it may also affect the viscosity of the system. For possible solutions please see 2.2.

Instabilities of sensiva® SC 50 containing emulsions caused by manufacturing process (homogenisation)

Possible reasons: • too high homogenisation speed • too long homogenisation time This phenomenon occurs easily in the presence of sensiva® SC 50, because it stabilises meta-stable small droplets. This can also effect the viscosity of W/O systems.

Possible solutions: • decrease the amount of oil • increasetheamountofviscositymodifyingagent(zincstearate)(figure1) • decreasethehomogenisationtimeandforce(figure2) • diminish the homogenisation time and force • substituteapolymericemulsifier(PEG-30dipolyhydroxystearate)fortheco-emulsifier • PolymericemulsifiersarequiteHLBindependent.TheincreaseinHLBcausedby

sensiva® SC 50 will not destabilise the emulsion • combination of the above solutions

ThefinalviscosityofW/Oemulsionscontainingsensiva®SC50 is reached after 7 days.

4 sensiva® SC 50 in W/O emulsions

4.1 To avoid water separation

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1 % ZnSt

1.5 % ZnSt

2 % ZnSt

2.5 % ZnSt

Influence of zinc stearate on viscosity

60 000

50 000

40 000

30 000

20 000

10 000

0 1 d 7 d 14 d 21 d 28 d

Time (days)

Visc

o (m

Pa.s

Sp

= D

, 3 rp

m)

Max Homogenisation

Med Homogenisation

Min Homogenisation

Influence of homogenisation on viscosity

50 000

40 000

30 000

20 000

10 000

0

Visc

o (m

Pa.s

Sp

= D

, 3 rp

m)

Figure 1: Influence of zinc stearate

on the viscosity of sensiva® SC 50

containing W/O emulsions.

1 d 7 d 14 d 21 d 28 d

Time (days)

Figure 2: Influence of homogeni-

sation time and force on

the viscosity of sensiva® SC 50

containing W/O emulsions.

4 sensiva® SC 50 in W/O emulsions

p 7

sensiva® SC 50 has a minimal effect on stability (< 1 month at 40 °C)

Possible solutions: •increasetheHLBoftheemulsifiersystembychangingtheratioofemulsifiers • HLB(sensiva®SC50+InitialEmulsifiers) < HLBInitialEmulsifier

sensiva® SC 50 has a moderate effect on stability (< 2 weeks at 40 °C)

Possible solutions: •increasetheHLBoftheemulsifiersystembychangingtheratioofemulsifiers • HLB(sensiva®SC50+InitialEmulsifiers) < HLBInitialEmulsifier •increasetheamountofmainemulsifier •sensiva®SC50affectstheemulsioninterface.Whentheamountofmainemulsifier is increased, the interface is stronger and sensiva® SC 50 is less destabilising. •increasetheHLBoftheemulsifiersystembysubstitutingahigherHLBcountertype; e.g.ceteareth-20orceteareth-25foroneorallemulsifiers • The decrease of HLB caused by sensiva® SC 50 is corrected. A disadvantage of this methodisthatthefinalviscositycanbelowerthanthatoftheinitialformula.

sensiva® SC 50 has a dramatic effect on stability (< 1 week at 40 °C)

Possible solutions: • combination of moderate effect solution •additionofapolymericemulsifier,suchasinulinlaurylcarbamate •PolymericemulsifiersarequiteHLBindependent.ThedecreaseinHLBcausedby sensiva® SC 50 does not destabilise the emulsion. •Polymericemulsifierspreventtheagglomerationofthedispersedphasebystericshielding. •additionofananionicco-emulsifier,suchascetearylalcohol,sodiumcetearylsulfate •Anionicemulsifiersareabletoformsmallandstabledroplets.However,theycanonly be used in the absence of cationic ingredients. • substitution of polar oils by vegetable oils (triglycerides) • sensiva® SC 50 has less effect on emulsions containing high amount of vegetable oils. • combination of the above solutions

Figure 3: Influence of caprylyl glycol

on the viscosity of sensiva® SC 50

containing O/W emulsions.

Caprylyl glycol = 0 %

Caprylyl glycol = 1 %

x = 15 % Vegetable Oil

x = 10 % Synthetic Oil

x = 5 % Medium Polar Oils

Visc

osity

(mPa

.s) r

pm =

12,

Spi

ndle

= D

, DVI

I+ 12 000

10 000

8 000

6 000

4 000

2 000

0

sensiva® SC 50 can cause an increase and decrease in viscosity of O/W emulsions. An increased viscosity of O/W emulsions with sensiva® SC 50 (> 1 %) indicates that this emulsion will not be stable. Smaller oil droplets are formed, which leads to a higher viscosity. sensiva® SC 50 migrates into the oil droplets at higher temperatures, which leads to instability. A viscosity drop can be observed if it is used in combination with vegetable oils. This effect is not seen when synthetic oils are used. To counter viscosity drop see 2.2. A unique and elegant solution is the addition of caprylyl glycol. Caprylyl glycol in combi-nationwithsensiva®SC50canincreasetheviscosity(figure3).

Viscosity at 20 °C

5 sensiva® SC 50 in O/W emulsions

5.2 Effect on viscosity

5.1 To avoid oil separation

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In this test, the schülke KoKo test, a mixture of bacteria, yeast and moulds is inoculated six times (once a week) into the test material with the goal of keeping the test material germ-free for this period. The inoculum contains pathogenic micro-organisms and germs which are well known for product spoilage. All species are cultivated separately and mixed directly before the addition, to ensure a constant composition and germ count of the inoculum. The total germ count of the combined inoculum is approximately 108-9 cfu/ml, equivalent to a germ count of approximately 106 cfu/ml of each individual organism.

A sample can be called well preserved, if it passes a period of six weeks under the above described laboratory conditions without showing microbial growth on the test batches. That means even after the sixth inoculation no microbial growth can be observed. From many years of experience in the use of this test method these results can state the microbiological stability of 30 months which is recommended for cosmetic products.

6 Frame Formulations

KoKo Test SM 021

25 g of each material to be tested

without preservative with x % preservative

2 days exposure time streak (see below) as sterility control

Germ spectrum

Bacteria: Moulds: Yeasts:

grampositiveKocuria rhizophilaStaphylococcus aureus

gramnegativeEnterobacter gergoviaeEscherichia coliKlebsiella pneumoniaePseudomonas aeruginosaPseudomonas flourescensPseudomonas putida

Aspergillus nigerPenicillium funiculosum

Candida albicans

Periodic microbiological preservation test

Weekly inoculation with 0.1 ml mixed suspension6 weeks = 6 inoculation cycles (titre 10 8-9 cfu/ml)

Streak weekly before each inoculation on CS-agar and SA-agar

Assessments:

– = free of growth

+ = slight growth

++ = moderate growth

+++ = heavy growth

storage at + 25 °C

Incubation of the nutrient media: 3 days at + 25 °C

agar plates

Based on this experience, several frame formulations for W/O and O/W emulsions with sensiva® SC 50 were developed. The stability of each was checked during storage at 40 °C for 3 months.All formulations were tested in challenge tests (schülke KoKo test) with different preservative blends supplied by schülke.

6.1 The schülke KoKo Test

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INCI Name Trade name Function % w/w

Phase A

PEG-7 Hydrogenated castor oil Dehymuls HRE7 Emulsifier 3.8

PEG-30 Dipolyhydroxystearate Arlacel P 135 Emulsifier 0.8

Zinc stearate Zincum N29 Viscositymodifier 2.0

Hexyl laurate Cetiol A Emollient 5.2

Cetearyl isononanoate Cetiol SN Emollient 6.1

Dicaprylylether Cetiol OE Emollient 5.2

Hexyldecanol Eutanol G 16 Humectant 2.5

Ethylhexylglycerin sensiva® SC 50 Skin conditioner 1.0

Phase B

Aqua q. s.

Glycerin Glycerin (85 %) Humectant 5.0

Magnesium sulfate MgSO4*7H2O Viscosity control 1.0

Preservative Preservative *

6 Frame Formulations

Preparation:

1. Heat Arlacel P 135 separately to 70 °C.

2. Mix components of phase A, except Arlacel P 135.

3. Add heated Arlacel P 135 to phase A.

4. Mix components of phase B.

5. Add phase B to A.

6. Homogenise 2 minutes at 8 000 rpm for 200 g.

Stir15minutesat100–120rpm.

W/O emulsion containing sensiva® SC 50 Ref. N° 586/062

Inoculation Cycles

0 1 2 3 4 5 6

unpreserved – +++B, Y, M

+++B, Y, M ./.

+ 0.9 % Phenoxyethanol – – – – – – –

+ 0.8 % euxyl® K 300 – – – – – – –

+ 0.1 % euxyl® K 100 – – – – – – –

+ 0.2 % euxyl® K 145 – – – – – – –

schülke KoKo Test report

Legend: 0 = Sterility control – = free of microbial growth

B = Bacteria + = slight growth

M = Moulds ++ = moderate growth

Sp = Sporeforming Bacteria +++ = massive growth

Y = Yeasts

6.2 W/O emulsion with sensiva® SC 50 Ref. N° 586/062

*) KoKo test results see test report below

p10

INCI Name Trade name Function % w/w

Phase A

Aqua q. s.

Glycerin Glycerine (99,5 %) Cold stability 3.0

Preservative Preservative *

Xanthan gum Keltrol T Anti-creaming agent 0.3

Phase B

Ceteareth-12 Emulgin B 1 (Sabowax CS11) Emulsifier 2.0

Ceteareth-20 Emulgin B 2 (Sabowax CS20) Emulsifier 2.0

Cetearyl alcohol Lanette O (Sabonal C 1618 50/50) Stabiliser 1.0

Capric/caprylic triglyceride Neoderm TCC Emollient 4.0

Squalane Squalane vegetale Emollient 0.5

Polydecene Nexbase FG2004 Emollient 0.5

Glyceryl stearate Sabowax GMS Stabiliser 4.0

Cetearyl alcohol, sodium cetearyl sulfate Lanette N (Sabowax NH) Co-emulsifier 2.0

Phase C

Ethylhexylglycerin sensiva® SC 50 Skin conditioner 1.0

Preparation:1.HeatphaseAto70–75°C. Disperse the Keltrol T gently into the water.2.HeatphaseBto70–75°C.3. Add phase B to A under stirring.

4. Homogenise 3 minutes at 10 000 rpm for 200 g.5. Add phase C.6. Cool to 40 °C while stirring.7. Homogenise 1 minute at 8 000 rpm.

O/W emulsion with sensiva® SC 50 and medium polar oils Ref. N° 586/171 PO

Inoculation Cycles

0 1 2 3 4 5 6

unpreserved – +++M

+++M ./.

+ 0.10 % euxyl® K 100 – – – – – – –

+ 0.16 % euxyl® K 510 – – – – – – –

+ 100 ppm Methyliso- thiazolinone – – – – – – –

schülke KoKo Test report

Legend: 0 = Sterility control – = free of microbial growth

B = Bacteria + = slight growth

M = Moulds ++ = moderate growth

Sp = Sporeforming Bacteria +++ = massive growth

Y = Yeasts

6.3 O/W emulsion with sensiva® SC 50 and medium polar oils Ref. N° 586/171 PO

*) KoKo test results see test report below

6 Frame Formulations

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Legend: 0 = Sterility control – = free of microbial growth

B = Bacteria + = slight growth

M = Moulds ++ = moderate growth

Sp = Sporeforming Bacteria +++ = massive growth

Y = Yeasts

INCI Name Trade name Function % w/w

Phase A

Aqua q.s.

Glycerin Glycerine (99,5 %) Cold stability 3.0

Preservative Preservative *

Xanthan gum Keltrol T Anti-creaming agent 0.3

Phase B

Ceteareth-12 Emulgin B1 (Sabowax CS11) Emulsifier 2.0

Ceteareth-20 Emulgin B2 (Sabowax CS20) Emulsifier 2.0

Cetearyl alcohol Lanette O (Sabonal C1618 50/50) Stabilising 1.0

Isopropyl palmitate Neoderm IPP Emollient 4.0

Isononyl isononanoate Neoderm ISN Emollient 4.0

C12-15 Alkyl benzoate Neoderm AB Emollient 2.0

Glyceryl stearate Sabowax GMS Stabilising 4.0

Cetearyl alcohol, sodium cetearyl sulfate Lanette N (Sabowax NH) Coemulsifier 2.0

Phase C

Ethylhexylglycerin sensiva® SC 50 Skin conditioner 1.0

Preparation:

1.HeatphaseAto70–75°C.DispersetheKeltrolT

gently into the water.

2.HeatphaseBto70–75°C.

3. Add phase B to A under stirring.

4. Homogenise 3 minutes at 10 000 rpm for 200 g.

5. Add phase C.

6. Cool to 40 °C while stirring.

7. Homogenise 1 minute at 8000 rpm.

O/W emulsion with sensiva® SC 50 and polar oils Ref. N° 586/171 SO

Inoculation Cycles

0 1 2 3 4 5 6

unpreserved – +++M

+++M ./.

+ 0.1 % euxyl® K 100 – – – – – – –

+ 0.16 % euxyl® K 510 – – – – – – –

schülke KoKo Test report

6.4 O/W emulsion with sensiva® SC 50 and polar oils Ref. N° 586/171 SO

*) KoKo test results see test report below

6 Frame Formulations

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INCI Name Trade name Function % w/w

Phase A

Aqua q.s.

Glycerin Glycerine (99,5 %) Cold stability 3.0

Preservative Preservative *

Xanthan gum Keltrol T Anti-creaming agent 0.2

Phase B

Ceteareth-12 Emulgin B1 (Sabowax CS11) Emulsifier 1.0

Ceteareth-20 Emulgin B2 (Sabowax CS20) Emulsifier 2.5

Cetearyl alcohol Lanette O (Sabonal C1618 50/50) Stabilising 1.0

Macadamia ternifolia Macadamia Nut Oil Vegetable oil 6.0

Prunus armaniaca Apricot Kernel oil Vegetable oil 6.0

Simmondsia chinensis Jojoba oil Vegetable wax 3.0

Glyceryl stearate Sabowax GMS Stabilising 4.0

Dimethicone DC200 350 cst Anti-whitening 1.0

Phase C

Ethylhexylglycerin sensiva® SC 50 Skin conditioner 1.0

Preparation:

1.HeatphaseAto70–75°C.DispersetheKeltrolT

gently into the water.

2.HeatphaseBto70–75°C.

3. Add phase B to A under stirring.

4. Homogenise 3 minutes at 10 000 rpm for 200 g.

5. Add phase C.

6. Cool to 40 °C while stirring.

7. Homogenise 1 minute at 8 000 rpm.

O/W emulsion with sensiva® SC 50 and vegetable oils Ref. N° 586/171 NO

Inoculation Cycles

0 1 2 3 4 5 6

Unpreserved – +++M

+++M ./.

+ 0.9 % Phenoxyethanol – – – – – – –

+ 0.1 % euxyl® K 100 – – – – – – –

+ 0.16 % euxyl® K 510 – – – – – – –

schülke KoKo Test report

Legend: 0 = Sterility control – = free of microbial growth

B = Bacteria + = slight growth

M = Moulds ++ = moderate growth

Sp = Sporeforming Bacteria +++ = massive growth

Y = Yeasts

6.5 O/W emulsion with sensiva® SC 50 and vegetable oils Ref. N° 586/171 NO

*) KoKo test results see test report below

6 Frame Formulations

p 13

INCI Name Trade name Function % w/w

Phase A

Sorbitan oleate, beeswax, stearic acid Montane 481V Emulsifier 8.0

PEG-45-Dodecylglycol copolymer Elfacos ST9 Emulsifier 2.0

Squalanea Fitoderm Emollient 30.0

Phase B

Aqua Solvent q.s.

Glycerin Glycerol 85 % Humectant 6.0

Magnesium sulfate MgSO4*7H2O Viscosity control 0.7

Phase C

Zinc oxide Zinc oxide Skin protectant 10.0

Phase D

Ethylhexylglycerin sensiva® SC 50 Skin care additive 1.0

Preservative Preservative *

Preparation:

1. Heat phase A and B separately to 80 °C.

2. Add phase B to A slowly while stirring.

3. After 4 minutes add zinc oxide.

4. Homogenise with a sufficient shear rate.

5. Add phase D.

6. Allow the emulsion to cool to 30 °C with gentle stirring.

Nappy rash creamRef N° 559/147

Inoculation Cycles

0 1 2 3 4 5 6

unpreserved – ++Y

+++Y

+++Y ./.

+ 0.5 % Phenoxyethanol – – – – – – –

+ 0.4 % Methylparaben – – – – – – –

schülke KoKo Test report

Legend: 0 = Sterility control – = free of microbial growth

B = Bacteria + = slight growth

M = Moulds ++ = moderate growth

Sp = Sporeforming Bacteria +++ = massive growth

Y = Yeasts

6.6 Nappy rash cream (W/O emulsion with sensiva® SC 50) Ref. N° 559/147

*) KoKo test results see test report below

6 Frame Formulations

p 14

INCI Name Trade name Function % w/w

Phase A

Arachidyl alcohol, behenyl alcohol, arachidyl glucoside Montanov 202 Emulsifier 5.0

Cetearyl ethylhexanoate Lanol 1688 Emollient 20.0

Ethylhexylglycerin sensiva® SC 50 Skin care additive 2.0

Phase B

Aqua Solvent q.s.

Phase C

Polysorbate 13, polyisobutene,polysorbate 20 Sepiplus 400 Viscosity control 0.2

Phase D

Preservative Preservative *)

*) KoKo test results see test report below

Preparation:

1. Heat phase A and B separately to 80 °C.

2. Add phase C to A while stirring until homogeneity.

3. Add phase B quickly while stirring and homogenise

for 2 minutes at 10 000 rpm for 250 g.

4. Cool down to 30 °C while stirring.

5. Add phase D and cool while stirring for 30 minutes.

O/W cream with sensiva® SC 50 Ref. N° 571/088

Inoculation Cycles

0 1 2 3 4 5 6

unpreserved – +++B, Y, M

+++B, Y, M ./.

+ 1.0 % euxyl® PE 9010 – – – – – – –

+ 1.0 % euxyl® K 320 – – – – – – –

+ 0.1 % euxyl® K 100 – – – – – – –

+ 0.12 % euxyl® K 220 – – – – – – –

+ 0.2 % euxyl® K 510 – – – – – – –

schülke KoKo Test report

Legend: 0 = Sterility control – = free of microbial growth

B = Bacteria + = slight growth

M = Moulds ++ = moderate growth

Sp = Sporeforming Bacteria +++ = massive growth

Y = Yeasts

6.7 O/W cream with sensiva® SC 50 Ref. N° 571/088

6 Frame Formulations

p 15

*) KoKo test results see test report below

INCI Name Trade name Function % w/w

Phase A

Sorbitan oleate, beeswax,stearic acid Montane 481V Emulsifier 8.0

PEG-45-Dodecylglycol copolymer Elfacos ST9 Emulsifier 1.0

Isononyl isononanoate Lanol 99 Emollient 5.0

Paraffinum liquidum Paraffin oil Emollient 25.0

Zinc stearate Zincum N29 Viscosity control 1.0

Ethylhexylglycerin sensiva® SC 50 Skin care additive 2.0

Phase B

Aqua Solvent q.s.

Glycerin Glycerol 85 % Humectant 6.0

Magnesium sulfate MgSO4*7H2O Viscosity control 0.7

Phase C

Preservative Preservative *

Preparation:

1. Heat phase A and B separately to 80 °C.

2. Add phase B to A slowly while stirring.

3.Homogeniseat55–65°Cforashorttime.

4. Allow the emulsion to cool to 30 °C with gentle stirring.

5. Add phase C with gentle stirring.

Protective cream for very dry skin Ref. N° 559/141B

Inoculation Cycles

0 1 2 3 4 5 6

unpreserved – ++B, Y, M

+++B, Y, M ./.

+ 0.1 % euxyl® K 100 – – – – – – –

schülke KoKo Test report

Legend: 0 = Sterility control – = free of microbial growth

B = Bacteria + = slight growth

M = Moulds ++ = moderate growth

Sp = Sporeforming Bacteria +++ = massive growth

Y = Yeasts

6.8 Protective cream for very dry skin (W/O with sensiva® SC 50) Ref. N° 559/141B

6 Frame Formulations

Our recommendations regarding our products are based on in-depth scientific testing in our Research Department; they are given in good faith, but no liability can be derived from them. It is the responsibility of the final product manufacturer to assure that claims made for the final product are in conformance with all applicable local laws. In other respect our Conditions of Sale and Supply apply.

schülke subsidiaries in:

Schülke&Mayr GmbH22840 Norderstedt | GermanyPhone +49 40 521 00- 0 | Fax +49 40 521 00 -244www.schuelke.com | [email protected]

BelgiumS.A. Schülke&Mayr Belgium N.V.1830 MachelenPhone +32-02-479 73 35Fax +32-02-479 99 66

NetherlandsSchülke&Mayr Benelux B.V.2003 LM-HaarlemPhone +31-23-535 26 34Fax +31-23-536 79 70

ChinaSchülke&Mayr GmbHShanghai Representative Office Shanghai 200041Phone +86-21-62 17 29 95Fax +86-21-62 17 29 97

SwitzerlandSchülke&Mayr AG8003 ZurichPhone +41-44-466 55 44Fax +41-44-466 55 33

FranceS&M France75341 Paris Cedex 07Phone +33-1- 44-11-00 -81Fax +33-1- 44-11-02 -41

United KingdomSchülke&Mayr UK Ltd.Sheffield S9 1ATPhone +44-114-2-54 35-00Fax +44-114-2-54 35-01

ItalySchülke&Mayr Italia S.r.l.20148 MilanoPhone +39-02-40 21 820Fax +39-02-40 21 829

USA schülke inc.Mt. Arlington, NJ 07856Phone +1-973-770-73-00Fax +1-973 -770-73-02

Other Distributors in:Africa (north) · Albania · Argentina · Australia · Austria · Belarus · Bosnia-Herzegovina · Brazil · Bulgaria · Canada · Croatia · Cyprus · Czech Republic · Denmark · Egypt · Estonia · Finland · Ghana · Greece · Hong Kong · Hungary · India · Indonesia · Iran · Israel · Japan · Jordan · Kazakhstan · Korea · Kuwait · Latin America · Latvia · Lebanon · Lithuania · Malaysia · Malta · Macedonia · Mexico · Middle East · Montenegro · New Zealand · Nigeria · Norway · Pakistan · Philippines · Poland · Portugal · Puerto Rico · Romania · Russia · Serbia · Singapore · Slovakia · Slovenia · Spain · South-Africa · Sweden · Syria · Taiwan · Thailand · Turkey · Ukraine · Vietnam

A company of the Air Liquide Group

208 | IV | 06.09 | C | RakoThis product information is not automatically updated.

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