Formulation Guidelines for SynoxylÒ HSS $ % 5 & 1 ' 6 + 8 $ 9 , 8 5 & _ ( ' = 2 8 , ) 1 & 9 & ; 5 B , % - 1 . 4 1 8 5 ) & , / 1 ' 7 & ' 6 a ) 3 - 1 1 ) V 8 b , , ) 1 8 1 5 , & , - 4 7 1 ' C 2 - 7 . , = $ , , \ . ) , = ' , , ' ' 3 - , , 8 ' & / 9 . 8 ' ) , = 1 : 9 d @ $ ^ , 5 1 ) , % & ' ( % ) * $ $ @ e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` 7 / 8 6 5 0 & - , 7 . = A : . , 4 , ' ' 7 & < ) ) 5 . . & / & 3 / 3 2 $ / , 5 C = & 1 1 $ . - & 6 - 1 ) - 5 . + 1 & 2 . * , . 1 8 ) $ & A ' % $ ` A 6 , + A ^ 7 9 4 - + . 4 ' * . - ' & / ) 5 1 % - . , 5 $ % $ % A ( Z 6 c W X A & , ? [ 7 - 9 = 9 . - , 1 7 6 . = 9 5 ) 1 $ - = \ % - 8 ] 7 ' = 1 . ' 3 5 ' 9 ; - . - 7 - , 4 1 & = 6 1 2 7 C 1 8 / / 3 4 & 7 - 1 ' 1 & ' & ` 7 9 $ % & ' ( % ) * + $ $ C 7 9 1 B ' ) ) ' A , & 6 B ' 8 3 / ) . 7 , ` & 1 - - $ % 9 ' & ' / ( ) % 5 ) = * 1 + B $ ' ) $ , ) ' A - 1 - 5 ' ) f / = ) 1 , & \ g h ; i C g 7 9 . & ' ) C + ' 3 ' - . ) . 7 1 C ? 2 7 , - . ) . 7 1 C j d a ; d Y ) < % ) [ 1 & V ' . 7 1 . & 5 ^ · ' 7 9 A , ' 1 7 8 9 : - 1 $ 9 8 % ) 7 & , , , ' 6 9 6 9 3 ( 7 1 % ) 4 ' ) 9 1 . . 8 , 7 , 7 % 1 & - 6 4 7 8 1 , 8 ' - @ 8 7 U 9 ' 1 . 3 5 5 . , & 7 1 6 8 7 , . ' ) 7 - 9 9 ' 1 / ' , ) ) 5 = 4 9 1 . 2 - . 1 8 , 1 B & / ' ) 8 ) % 5 4 1 8 8 7 1 ; - ' ' . ) : / = ' , , ) 5 , V 2 1 8 5 % , - 7 . & 7 ) ) , 9 V 1 . 1 7 , ' 3 ' & , ) ) & , B 1 & ' 7 8 4 3 9 / ) . . - 7 , 1 ' & @ * + $ $ - 9 ' / ) 5 = 1 / - 1 5 . 7 . ) 1 : 1 ) ' B d 7 ' a A ` Z A l ' B B , & , - 9 1 5 B ' 8 3 / ) . 7 , ' & @ e & - / & - 2 8 1 1 & k · B ' 8 4 3 9 ) / ' 1 7 : ) ' 1 . 7 - ) , 7 - ' . ' & = - , ) B , % & ' ( % ) A V . @ , 8 ' 1 & 2 . d - ^ * 1 7 ; _ $ C ' & 9 3 3 5 ' 1 $ / ) & \ 5 5 / ] - / = B B , - ' 2 , ' 1 & - 6 7 $ & 6 % & @ ' ] ( ' % 8 ) 5 m + . , ) $ % $ - f < , Y : & ' 4 = 8 1 ' 7 & 1 V 2 ' 7 , & ' 1 , & . & d & f 5 d . 8 & 7 , . 7 ; , . ' 7 6 , & ' 1 6 & . - 4 / 4 ) 8 , 1 2 ' . 7 , 4 ' 7 & , 3 - / C 3 / - 1 @ ` + $ $ , - . ) - ' 2 ' 3 4 . 7 , = ) 1 A , 7 9 , & ' 8 6 . & , 2 W X B , ) 7 1 8 - C c & ? . & 5 U , ? n @ $ % & ' ( % ) * + $ $ , - - 7 . = ) 1 · . 2 8 ' - - . A , 5 1 4 + 8 . & 6 1 4 + o p 7 ' q l A 9 , 2 9 3 . < 1 - , 7 - / , 7 . = ) 1 B ' 8 c & ? - / & - 2 8 1 1 & - 7 9 . 7 7 % 4 , 2 . ) ) % k 8 1 0 / , 8 1 4 + r s @ @ ^ $ % & ' ( % - , ) * + $ $ , - B / ) ) % 2 ' 3 4 . 7 , = ) 1 A , 7 9 . A , 5 1 8 . & 6 1 ' B 1 3 / ) - , B , 1 8 - C & ' & ; , ' & , 2 . & 5 . & , ' & , 2 · 1 3 / ? & ) 1 B , ' 1 8 B - 7 . 9 - A 1 , 1 5 1 ) . ) ) . - . & 7 9 , 2 5 < 2 1 ' & - , & 7 6 1 B . B 6 1 2 1 7 , & : 7 - . 1 2 & ' 5 4 3 = ' , ) & % . 3 7 , 1 ' 8 , & 2 B ' , B ) 3 B W ' X 8 B , 3 ) 1 7 1 8 8 - @ - B ' 8 . 2 9 , 1 : , & 6 9 , 6 9 $ \ ] C = 8 ' . 5 · - 4 . 1 & 2 7 8 5 / $ 3 - \ / ] & = - ' 2 ' 8 - 7 1 1 1 & - 8 , ] & ' 2 8 ) 3 / 5 / ) 1 . + 7 , ' ' 3 & ' - u . > ) j . 7 ; 4 4 8 ' 4 8 , . 7 1 B , ) 3 B ' 8 C d k . 1 ? 1 8 - . & 5 1 3 ' ) ) , 1 & 7 - 7 ; , - . @ _ 3 2 ^ v U ) . 9 7 , 1 C - Y - : % - ' 7 = 1 1 & V 3 2 ' ' & / 1 ) t 5 $ = % 1 & B ' / 8 ( 7 % 9 ) 1 * + 8 $ ' 4 $ 7 , . 3 - , . V 1 - 5 7 = . = , % ) / , V 1 - , 8 & 6 w @ August 2014 x y } ~ z z { | } z ~ { { z ~ { ~ | | ~ { ~ { z z z { z | x | y z { ~ { y | } z ~ ~ z ~ { ~ | z { | { z | z { | z ~ | z y z ~ z z { | y z y z { z z z { y | } z { z | | z ~ ~ z | { ~ | { ~ z { | ~ z z z ~ y z | z z ~ | z { { ~ z | ~ { { z z z ~ { ~ z z y | z { | z z | z { ~ ~ | | ~ ~ { | z z z } ~ | z z ~ z z | } ~ y } z z { { y y z z ! " # Broad Spectrum UVA/UVB Sunscreen Lotion SPF 46 Formulation#RC-01-53 In-vivo SPF 46 (FDA protocol- 10 subjects) In-vivo SPF 30 (without Synoxyl® HSS) INCI name Phase A1 Water Disodium EDTA Butylene Glycol Trade Name/Supplier % w/w Water(demineralized) Versene Na/Dow Butylene Glycol/Ruger Qs 0.10 2.00 Glycerine Emery 916/BASF 2.00 Keltrol® CG-T/CP Kelko Carbopol Ultez 21/Lubrizol 0.10 0.25 Finsolv TN/Finetex Emulim 22/Gattefosse Arlacel 165/Croda Synoxyl® HSS/Sytheon Eusolex HMS/EMD Chemicals Eusolex OS/EMD Chemicals Eusolex 9020/EMD Chemicals Crodacol C-70/Croda Performa V 6112/New Phase Technologies Dow Corning 200,100 cst/Dow Corning 5.00 2.00 1.50 2.00 10.00 5.00 2.00 1.00 1.00 1.00 TEA 99% 0.20 Phase A2 Xanthan Gum Acrylates/C10-30 Alkyl Acrylate Crosspolymer Phase B C12-15 Alkyl Benzoate Tribehenin PEG -20 Esters Glyceryl Stearate, PEG-100 Stearate Trimethoxybenzylidene Pentanedione Homosalate Octyl Salicylate Avobenzone Cetyl Alcohol C30+Olefin / Undecylenic Acid Copolymer Dimethicone Phase C Triethanolamine Phase D Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol Lexgard HPO/Inolex 1.00 100.00 Total Procedure: Combine A-1; disperse A2 one by one in A1 while stirring and heat A to 75°C. Combine ingredients of phase B and heat to 75 0C. Add phase B to A with good mixing. Homogenize mixture at moderate speed for 3-5 min while adding phase C (adjust pH to 5.5-6.0). Cool batch to 40°C with propeller agitation until mixture is homogeneous. Add phase D while continue mixing. Notes: • pH - 5.5-6.0 • Viscosity – 60,000- 80,000mPas (Brookfield RVT, Spindle C, 10 rpm) at 25°C The information given and the recommendations made herein are based on our research and are believed to be accurate but no guarantee of their accuracy is made. This information is intended to be helpful, but no warranty is expressed or implied as to the results obtained from use of the formulation, procedure or products suggested herein. Neither is any permission or recommendation to practice any invention covered by patent either expressed or implied. ! " Broad-spectrum UVA/UVB sunscreen spray SPF 45 Formulation#RC-01-80 A In-vivo SPF 45 (FDA protocol- 5 subjects) In-vivo SPF 30 (without Synoxyl® HSS) INCI name Phase A Ethanol VA/Butyl Maleate/Isobornyl Acrylate Copolymer Phase B Avobenzone Trimethoxybenzylidene Pentanedione Homosalate Octyl Salicylate Diisopropyl Adipate Phase C Trade Name/Supplier % w/w Ethanol Advantage Plus/Ashland 42.00 2.00 Eusolex 9020/EMD Synoxyl® HSS/Sytheon Eusolex HMS/EMD Eusolex OS/EMD Dermol DIA/Alzo 2.00 2.00 10.00 5.00 10.00 Isodecyl Neopentanoate Isosorbide Dicaprylate Total Ceraphyl SLK/Ashland Synovea DOI/Sytheon 20.00 2.00 100.00 Procedure: Combine phase A; Pre-mix phase B and heat up to 75°C until is completely free of solids. Add phase A and C to phase B while mixing. ______________________________________________________________________________________________ The information given and the recommendations made herein are based on our research and are believed to be accurate but no guarantee of their accuracy is made. This information is intended to be helpful, but no warranty is expressed or implied as to the results obtained from use of the formulation, procedure or products suggested herein. Neither is any permission or recommendation to practice any invention covered by patent either expressed or implied ! " Broad Spectrum UVA/UVB Sunscreen Emulsion SPF 32 Formulation#RC-01-78 In Vivo SPF 32 (FDA protocol- 5 subjects) INCI name Phase A1 Water Disodium EDTA Glycerin Butylene Glycol Phase A2 Xanthan Gum Acrylates/C10-30 Alkyl Acrylate Crosspolymer Phase B C12-15 Alkyl Benzoate Tribehenin PEG-20 Esters Glycerol stearate , PEG-100 stearate Trimethoxybenzylidene Pentanedione Homosalate Octyl Salicylate Avobenzone Cetyl Alcohol C30+Olefin / Undecylenic Acid Copolymer Dimethicone Phase C Triethanolamine Phase D Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol Total Trade Name/Supplier % w/w Water(demineralized) Versene Na/Dow Emery 916/BASF Butylene Glycol/Ruger Qs 0.10 2.00 2.00 Keltrol® CG-T/CP Kelko Carbopol Ultez 21/Lubrizol 0.15 0.25 Finsolv TN/Finetex Emulium 22/Gattefosse Arlacel 165/Croda Synoxyl® HSS/Sytheon Eusolex HMS/EMD Eusolex OS/EMD Eusolex 9020/EMD Crodacol C-70/Croda Performa V 6112/New Phase Technologies Dow Corning 200,100 cst/Dow Corning 6.00 2.00 1.00 1.50 6.00 4.00 1.50 1.00 1.00 TEA 99% 0.15 Lexgard HPO/Inolex 1.00 100.00 1.00 Procedure: Combine A-1; disperse A2 one by one in A1 while stirring and heat A to 75°C. Combine ingredients of phase B and heat to 75 0C. Add phase B to A with good mixing. Homogenize mixture at moderate speed for 3-5 min while adding phase C (adjust pH to 5.5-6.0). Cool batch to 40°C with propeller agitation until mixture is homogeneous. Add phase D while continue mixing. Notes: • pH - 5.5-6.0 • Viscosity – 40,000- 60,000mPas (Brookfield RVT, Spindle C, 10 rpm) at 25°C x y } z ~ z { { y | z } ~ z { { { ~ | ~ | z ~ z { z z | z ~ x y { | { z ~ { | { z y ~ z } ~ z ~ { ~ z | { | { | z z { | ~ | z z y ~ z z z { y z | z y z z z { } { | y z z { | z ~ | ~ | z ~ | { { { ~ z z z | ~ y z z | z ~ ~ z z { | z { ~ { { z z z | ~ ~ ~ z y { z z z | { z | ~ z | | { ~ { ~ | | z } ~ ~ z | z z z ~ } z ~ y } z { y z z | ! " Broad Spectrum UVA/UVB Sunscreen Lotion with ZnO Formulation#RC-01-86A In-vivo SPF 33 (FDA protocol - 5 subjects) In-vivo SPF 21 (without Synoxyl® HSS) INCI name Phase A1 Water Disodium EDTA Butylene Glycol Phase A2 Xanthan Gum Phase B Potassium Cetyl Phosphate Oleth-10 Glyceryl Dibehenate, Tribehenin, Glyceryl Behenate Stearyl/PPG-3 Myristyl Ether Dimer Dilinoleate Dimethicone Phase C Ethyl Macademiate Trimethoxybenzylidene Pentanedione Zinc Oxide, Simmondsia Chinensis (Jojoba) Seed Oil,Glyceryl Isostearate, Polyhydroxystearic Acid Phase D Polyacrylate 13,Polyisobutene,Polysorbate 20 Phase E C8-22 Alkyl Acrylate/Methacrylic Acid Crosspolymer Phase F Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol Trade Name/Supplier % w/w Water(demineralized) Versene Na/Dow Butylene Glycol/Ruger Qs 0.10 3.00 Keltrol® CG-T/CP Kelko 0.20 Amphisol K/DSM Brij O10 /Croda Compritol 888/Gattefosse Liquiwax PolyIPL/Croda Dow Corning 200,100 cst/Dow Corning 1.50 1.00 1.50 1.00 1.00 Floramac 10/Floratech Synoxyl® HSS/Sytheon 5.00 1.50 ZinClear IM 50 JJ/Dow 20.00 (10% ZnO) Sepiplus 400/Seppic 1.50 Intelimer 8600/Air Products 3.00 Lexgard HPO/Inolex 1.00 Total 100.00 Procedure: Combine A-1; disperse A2 one by one in A1 while stirring and heat A to 75°C. Premix phase C separately and heat up to 750C until free of solids and add to phase C before emulsification. Combine ingredients of phase B and heat to 75 0C. Add phase B to A with good mixing. Homogenize mixture at moderate speed for 3-5 min while adding phase D. Cool batch to 450C with propeller agitation until mixture is homogeneous. Add phase E &F while continue mixing. Notes: • pH - 7.20-7.80 • Viscosity – 30,000- 45,000mPas (Brookfield RVT, Spindle C, 10 rpm) at 25°C The information given and the recommendations made herein are based on our research and are believed to be accurate but no guarantee of their accuracy is made. This information is intended to be helpful, but no warranty is expressed or implied as to the results obtained from use of the formulation, procedure or products suggested herein. Neither is any permission or recommendation to practice any invention covered by patent either expressed or implied. ! " Broad Spectrum UVA/UVB Sunscreen Lotion SPF 50+(expected) Formulation#RC-01-100 INCI name Phase A1 Water Disodium EDTA Butylene Glycol Trade Name/Supplier % w/w Water(demineralized) Versene Na/Dow Butylene Glycol/Ruger Qs 0.10 2.00 Glycerine Emery 916/BASF 2.00 Keltrol® CG-T/CP Kelko Carbopol Ultez 21/Lubrizol 0.10 0.30 Finsolv TN/Finetex Emulim 22/Gattefosse Arlacel 165/Croda Synoxyl® HSS/Sytheon Eusolex HMS/EMD Chemicals Eusolex OS/EMD Chemicals Eusolex 9020/EMD Chemicals 5.00 2.00 1.50 2.50 15.00 5.00 2.50 Cetyl Alcohol C30+Olefin / Undecylenic Acid Copolymer Crodacol C-70/Croda Performa V 6112/New Phase Technologies 1.00 1.00 Dimethicone Phase C Triethanolamine Phase D Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol Dow Corning 200,100 cst/Dow Corning 1.00 TEA 99% 0.20 Phase A2 Xanthan Gum Acrylates/C10-30 Alkyl Acrylate Crosspolymer Phase B C12-15 Alkyl Benzoate Tribehenin PEG -20 Esters Glyceryl Stearate, PEG-100 Stearate Trimethoxybenzylidene Pentanedione Homosalate Octyl Salicylate Avobenzone Lexgard HPO/Inolex 1.00 100.00 Total Procedure: Combine A-1; disperse A2 one by one in A1 while stirring and heat A to 75°C. Combine ingredients of phase B and heat to 75 0C. Add phase B to A with good mixing. Homogenize mixture at moderate speed for 3-5 min while adding phase C (adjust pH to 5.5-6.0). Cool batch to 40°C with propeller agitation until mixture is homogeneous. Add phase D while continue mixing. Notes: • pH - 5.5-6.0 • Viscosity – 60,000- 80,000mPas (Brookfield RVT, Spindle C, 10 rpm) at 25°C ________________________________________________________________________________________________ The information given and the recommendations made herein are based on our research and are believed to be accurate but no guarantee of their accuracy is made. This information is intended to be helpful, but no warranty is expressed or implied as to the results obtained from use of the formulation, procedure or products suggested herein. Neither is any permission or recommendation to practice any invention covered by patent either expressed or implied ! "
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