BPO wash emulsion composition

Abstract

A topical dermatological/pharmaceutical composition is described that includes BPO wherein the composition is a wash composition with desirable tolerance, stability and foaming properties. The composition can include: a) benzoyl peroxide (BPO); b) at least one anionic and/or non-ionic surfactant, selected from zinc coceth sulfate; sodium cocoyl isethionate, sodium lauroyl isethionate, C14-C16 α-olefinsulfonates, preferably its sodium salt and decyl glucoside; c) zinc gluconate; d) dipotassium glycyrrhizate; e) an oily phase; f) an aqueous phase; and g) at least one non-ionic emulsifier from the family of sugar ester derivatives, and/or polyglycerol esters and/or gemini surfactants. The composition is preferably in the form of an oil in water emulsion. Also described, is the use of such composition for the treatment of dermatological disorders, and in particular in the treatment of acne.

Claims

1. A topical wash composition consisting of: (a) between 1% w/w and 5% w/w benzoyl peroxide (BPO); (b) between 0.5% w/w and 5% w/w expressed by weight of active material relative to the total weight of the composition of at least one anionic and/or non-ionic surfactant, selected from the group consisting of zinc coceth sulfate, sodium cocoyl isethionate, and sodium lauroyl isethionate; (c) between 0.1% w/w and 1% w/w zinc gluconate; (d) between 0.1% w/w and 1% w/w dipotassium glycyrrhizate; (e) at least one compound selected from vegetable oils, mineral oils, animal oils, synthetics oils, silicones, and mixtures thereof; (f) between 5% w/w and 90% w/w water; (g) between 0.1% and 5% of at least one non-ionic emulsifier selected from the family of sugar ester derivatives, polyglycerol esters, gemini surfactants, and mixtures thereof; and (h) one or more pharmaceutically acceptable excipients selected from the group consisting of: (i) gelling agents selected from polyacrylamides, acrylates/C10-30 alkyl crosspolymer, “electrolyte-insensitive” carbomers, polysaccharides, guar gum, cellulose derivatives, magnesium aluminum silicates, neutralized polymeric sulfonic acid polymers, and mixtures thereof; (ii) wetting agents selected from the group consisting of polyoxyethylene/polyoxypropylene copolymers, propylene glycol, dipropylene glycol, lauroglycol, propylene glycol dipelargonate, ethoxydiglycol, and mixtures thereof; (iii) antioxidants selected from the group consisting of Vitamin E and its derivatives, Vitamin C and its derivatives; butylated hydroxytoluene, sodium metabisulfite, and combinations thereof; (iv) vitamins and/or vitamin derivatives selected from vitamin E and its derivatives, vitamin C and its derivatives, vitamin PP, niacinamide, and combinations thereof; (v) soothing agents and/or anti-irritants selected from the group consisting of PPG-12/SMDI copolymer, allantoin and its derivatives, hyaluronic acid, polyquaternium-51, D-panthenol, and aloe vera; (vi) lecithins and/or phospholipids; (vii) cholesterol and/or cholesterol derivatives; (viii) preservatives selected from the group consisting of benzalkonium chloride, bronopol, chlorhexidine, chlorocresol and its derivatives, ethyl alcohol, phenoxyethanol, potassium sorbate, sodium benzoate diazolidinylurea, benzyl alcohol, and parabens; (ix) acids and/or bases; (x) chelating agents; (xi) humectants; (xii) foam boosters; (xiii) foam smoothing agents (xiv) perfume solubilizing agents; (xv) polyols; and (xvi) refatting agents, wherein the composition does not comprise a retinoid; wherein the composition does not comprise ethanol; and wherein at least 90% of the benzoyl peroxide present at formulation remains present in the composition after three months at room temperature.

2. The composition according to claim 1, wherein the composition is a foaming composition.

3. The composition according to claim 1, wherein the composition is in the form of an oil in water emulsion.

4. The composition according to claim 1, wherein glycerin is present at a concentration of between 0.1% and 10% by weight, relative to the total weight of the composition.

5. The composition according to claim 1, wherein the benzoyl peroxide is present at a concentration of between 2.5% and 5% by weight, relative to the total weight of the composition.

6. The composition according to claim 1, wherein the concentration of zinc gluconate, expressed by weight relative to the total weight of the composition, is between 0.15% and 0.3%.

7. The composition according to claim 1, wherein the concentration of dipotassium glycyrrhizate, expressed by weight relative to the total weight of the composition, is between 0.15% and 0.3%.

8. A method of treating acne vulgaris, the method comprising administering an effective amount of the composition according to claim 1 to an individual subject in need thereof.

9. A method of treating or improving acne in the skin of an individual subject, the method comprising administering to the individual subject an effective amount of the composition according to claim 1.

10. The composition as defined in claim 1, wherein the composition is formulated for inhibiting or treating common acne.

11. The composition according to claim 1, wherein the gelling agent is Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer & Isohexadecane & Polysorbate 80 or Polyacrylamide & C13-14 Isoparaffin & Laureth-7.

12. The composition according to claim 1, wherein the gelling agent is Acrylates/C10-30 Alkyl Acrylate Crosspolymer.

13. The composition according to claim 1, wherein the gelling agent is xanthan gum or pectin.

14. The composition according to claim 1, wherein the gelling agent is hydroxypropyl methylcellulose or hydroxyethylcellulose.

15. The composition according to claim 1, wherein the gelling agent is ammonium acryloyl dimethyltaureate/carboxyethyl acrylate crosspolymer.

16. The composition according to claim 1, wherein benzoyl peroxide (BPO), zinc gluconate, and dipotassium glycyrrhizate are the sole active ingredients.

17. The composition according to claim 1, wherein at least about 90% of the benzoyl peroxide in the composition remains in the composition after storage at 40° C. for one to two months.

18. The composition of claim 1, wherein the humectants are selected from the group consisting of propylene glycol, glycerin, pentylene glycol, 1-2 hexanediol, caprylyl glycol, propane-1,3-diol, or mixtures thereof.

19. The composition of claim 1, wherein the anionic and/or non-ionic surfactant is zinc coceth sulfate.

20. The composition of claim 1, wherein the composition does not comprise any gelling agents.

21. The composition of claim 1, wherein the polyoxyethylene/polyoxypropylene copolymers are poloxamers.

Description

EXAMPLES

Example 1

Comparative Stability Test to Demonstrate the Chemical Instability of BPO with Classical Amphoteric Surfactants. High Pressure Liquid Chromatography (HPLC) Analysis with UV Detection was Used to Quantify BPO in the Samples

(1) Composition containing purified water, BPO and 5% sodium cocoamphoacetate, an amphoteric surfactant, sold under the product name REWOTERIC® AM C by Evonik or AMPHOSOL® 1C from Stepan.

(2) TABLE-US-00001 Composition % w/w Purified water 92.5 BPO 2.5 Sodium cocoamphoacetate 5

(3) Chemical stability of BPO in purified water and 5% Sodium cocoamphoacetate after 1 month at 40° C.

(4) TABLE-US-00002 Sampling interval % BPO (relative to initial value) T0 (initial) 100 T1M (40° C.) <0.1

(5) The results indicate that no BPO was retrieved in the solution after 1 month, thereby demonstrating that all BPO added to the composition during manufacture and assayed at the initial interval (T0) was degraded. Composition containing purified water, BPO and 5% of disodium cocoamphodiacetate, an amphoteric surfactant sold under the product name REWOTERIC® AM 2 C NM by Evonik.

(6) TABLE-US-00003 Composition % w/w Purified water 92.5 BPO 2.5 Disodium cocoamphoacetate 5

(7) Chemical stability of BPO in purified water and 5% Disodium cocoamphodiacetate after 1 month at 40° C.

(8) TABLE-US-00004 Sampling interval % BPO (relative to initial value) T0 (initial) 100 T1M (40° C.) <0.1

(9) The results indicate that no BPO was retrieved in the solution after 1 month, thereby demonstrating that all BPO added to the composition during manufacture and assayed at the initial interval (T0) was degraded.

Example 2

Chemical Stability of BPO with Mild Anionic and Non-Ionic Surfactants.

(10) Composition containing purified water, BPO and 5% of sugar ester (sucrose laurate) from the non-ionic group of surfactants.

(11) TABLE-US-00005 Composition % w/w Purified water 92.5 BPO 2.5 sucrose laurate 5 Chemical stability of BPO in purified water and 5% of sugar ester (Sucrose laurate) after storage for 2 months (T2M) at 40° C.

(12) TABLE-US-00006 Sampling interval % BPO (relative to initial value) T0 (initial) 100 T1M (40° C.) 100.0 T2M (40° C.) 99.6

(13) The results indicate that BPO is stable (assay values between 90-110% of target) in purified water and 5% Sucrose laurate after 2 months storage at 40° C. Composition containing purified water, BPO and 5% of Decyl glucoside (non-ionic surfactant).

(14) TABLE-US-00007 Composition % w/w Purified water 92.5 BPO 2.5 Decyl glucoside 5 Chemical stability of BPO in purified water and 5% of Decyl glucoside after 2 months storage at 40° C.

(15) TABLE-US-00008 Sampling interval % BPO (relative to initial value) T0 (initial) 100 T1M (40° C.) 96.1 T2M (40° C.) 97.4

(16) The results indicate that BPO is stable in purified water and 5% of Decyl glucoside after storage for 2 months at 40° C. Composition containing purified water, BPO and 5% Zinc coceth sulfate (mild anionic surfactant)

(17) TABLE-US-00009 Composition % w/w Purified water 92.5 BPO 2.5 Zinc coceth sulfate 5

(18) Chemical stability of BPO purified water, BPO and 5% Zinc coceth sulfate after 2 months at 40° C.

(19) TABLE-US-00010 Sampling interval % BPO (relative to initial value) T0 (initial) 100 T1M (40° C.) 94.7 T2M (40° C.) 97.1

(20) The results indicate that BPO is stable in the solution after 2 months at 40° C. Composition containing purified water, BPO and 5% Sodium cocoyl isethionate (mild anionic surfactant)

(21) TABLE-US-00011 Composition % w/w Purified water 92.5 BPO 2.5 Sodium cocoyl isethionate 5

(22) Chemical stability of BPO in water, BPO and 5% Sodium cocoyl isethionate after storage for 2 months at 40° C.

(23) TABLE-US-00012 Sampling interval % BPO (relative to initial value) T0 (initial) 100 T1M (40° C.) 100.8 T2M (40° C.) 101.3

(24) The results indicate that BPO is stable in a solution of water and 5% Sodium cocoyl isethionate after storage for 2 months at 40° C. Composition containing purified water, BPO and 5% Sodium methyl cocoyl taurate (mild anionic surfactant).

(25) TABLE-US-00013 Sampling interval % BPO (relative to initial value) T0 (initial) 100 T1M (40° C.) 90.1

(26) The results indicate that BPO is stable in a solution of water and 5% Sodium methyl cocoyl taurate after storage for 1 month at 40° C.

(27) For examples 3 to 21, the general manufacturing process was as follows:

(28) Step 1:In the main beaker, weigh the required quantity of purified water and heat to 75° C. before dispersing the Magnesium Aluminium silicate.

(29) Step 2:Cool to 60° C. and add xanthan gum while mixing.

(30) Step 3:Maintain at 60° C. and continue mixing until the gelling agents are hydrated, then add EDTA and foaming surfactants. Mix until homogeneous.

(31) Step 4:Cool to 50° C. and incorporate PEG-75 (as appropriate) and Dipotassium glycyrrhizate while mixing. Mix until homogeneous.

(32) Step 5:Cool to 40° C. and introduce Zinc gluconate and adjust pH with citric acid. Mix until homogeneous.

(33) Step 6:In a secondary beaker, prepare the predispersion of BPO using poloxamer and propylene glycol with high shear maintained at low temperature (with an ice bath).

(34) Step 7:Add the predispersion of BPO in the main beaker while mixing. Continue cooling.

(35) Step 8:Add other additives, as needed (e.g. emulsifying surfactants, oils or perfume), to the preparation while mixing. Cool to 30° C. and terminate mixing.

(36) All the exemples described below are physically stable after 3 months at RT (room temperature), 30° C. and 40° C.

Example 3

(37) TABLE-US-00014 Composition % w/w Purified water QSAD 100 Glycerin & caprylic/capric triglycerides & 2 aqua & sucrose laurate Hydrogenated polyisobutene 8 magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Zinc coceth sulfate (25% in water) 8.0 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.05

(38) Chemical stability of BPO in the composition of example 3 after 3 months of storage at RT and 30° C. and 1 month at 40° C.:

(39) TABLE-US-00015 Storage Assay values per interval** conditions T0 T1M T2M T3M RT 100 97.6 98.2 98 30° C. — — 98.9 40° C. 94.0 — — **Assay value = percentage of T0.

(40) Data indicated that BPO is chemically stable for 3 months at RT and 30° C. in the formulation as described in example 3.

Example 4

(41) TABLE-US-00016 Composition % w/w Purified water QSAD 100 Glycerin& caprylic/capric triglycerides & aqua & 2 sucrose laurate Hydrogenated polyisobutene 8 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Decyl glucoside (55% in water) 6 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.05

(42) Chemical stability of BPO in the composition of example 4 after storage for 3 months at RT and 30° C. and 1 month at 40° C.

(43) TABLE-US-00017 Storage Assay values per interval** conditions T0** T1M** T2M** T3M** RT 100 98.7 95.3 111.6 30° C. 95.3 40° C. 93.5 **Assay value = percentage of T0.

(44) Data indicated that BPO is chemically stable for 3 months at RT and 30° C. and 1 month at 40° C. in the formulation as described in example 4.

Example 5

(45) TABLE-US-00018 Composition % w/w Purified water QSAD 100 Glycerin & caprylic/capric triglycerides & 2 aqua & sucrose laurate Hydrogenated polyisobutene 8 Magnesium aluminium silicate 5 Xanthan gum 0.5 Sodium lauroyl methyl isethionate (85% purity) 2.5 Disodium EDTA 0.1 Poloxamer 124 0.2 propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.15

(46) Chemical stability of BPO in the composition of example 5 after storage for 3 months at RT/30° C. and 2 months at 40° C.:

(47) TABLE-US-00019 Storage Assay values per interval** conditions T0 T1M T2M T3M RT 100 101.5 102.6 100.6 30° C. 96.7 40° C. 97.4 92.8 **Assay value = percentage of T0.

(48) Data indicated that BPO is chemically stable for 3 months at RT and 30° C. and 2 months at 40° C. in the formulation as described in example 5:

Example 6

(49) TABLE-US-00020 Composition % w/w Purified water QSAD 100 glycerin & caprylic/capric triglycerides & 2 aqua & sucrose laurate Hydrogenated polyisobutene 8.0 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium C14-C16 olefin sulfate 2 Disodium EDTA 0.1 Poloxamer 124 0.2 propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.15 Fragrance 0.25 PEG-40 hydrogenated castor oil 0.25

(50) Chemical stability of BPO in the composition of example 7 after storage 3 months at RT and 30° C. and 1 month at 40° C.:

(51) TABLE-US-00021 Storage Assay values per interval** conditions T0 T1M** T2M** T3M** RT 100 101.2 99.9 98.1 30° C. 94.6 40° C. 97.2 **Assay value = percentage of T0.

(52) Data indicated that BPO is chemically stable for 3 months at RT and 30° C. and 1 month at 40° C. in the formulation as described in example 6.

Example 7

(53) TABLE-US-00022 Composition % w/w Purified water QSAD 100 Glycerin& caprylic/capric triglycerides & 2 aqua & sucrose laurate Glycerin 4.95 Mineral oil 8 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium C14-C16 olefin sulfonate 1 Decyl glucoside (55% in water) 3 Disodium EDTA 0.1 Poloxamer 124 0.2 propylene glycol 2 PEG-75 2 BPO 2.6 Citric acid 0.15 Potassium sorbate 0.1 Benzyl Alcohol 0.50

Example 8

(54) TABLE-US-00023 Composition % w/w Purified water QSAD 100 Glycerin& caprylic/capric triglycerides & aqua & 2 sucrose laurate Mineral oil 1 Dimethicone 350 cst 7 Ammonium acryloyl dimethyltaurate/ 1.5 carboxyethyl acrylate crosspolymer Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium methyl lauroyl isethionate (85% purity) 2.5 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.05

Example 9

(55) TABLE-US-00024 Composition % w/w Purified water QSAD 100 Glycerin & caprylic/capric triglycerides & aqua 2 & sucrose laurate Hydrogenated polyisobutene 8 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium lauroyl Oat amino acid (32% in water) 10 Sorbitan sesquicapylate 0.30 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid monohydrated 0.15 Fragrance 0.25 PEG-40 hydrogenated castor oil 0.25

Example 10

(56) TABLE-US-00025 Composition % w/w Purified water QSAD 100 Glycerin& caprylic/capric triglycerides & 2 aqua & sucrose laurate Hydrogenated polyisobutene 8 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium methyl cocoyl taurate (30% purity) 8 Cocamidoproyl hydroxysultaine 2 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 Pentylene glycol 3 Caprylyl glycol 0.50 BPO 2.6 Citric acid 0.15 Fragrance 0.25 PEG-40 hydrogenated castor oil 0.25

Example 11

(57) TABLE-US-00026 Composition % w/w Purified water QSAD 100 Polyglyceryl-10 myristate 2 Hydrogenated polyisobutene 8 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium C14-C16 olefin sulfonate 2 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.15

Example 12

(58) TABLE-US-00027 Composition % w/w Purified water QSAD 100 Glycerin& caprylic/capric triglycerides & 2 aqua & sucrose laurate Hydrogenated polyisobutene 8 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium lauryl glucose carboxylate and 3 lauryl glucoside (35% in water) Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.15

Example 13

(59) TABLE-US-00028 Composition % w/w Purified water QSAD 100 Glycerin& caprylic/capric triglycerides & 2 aqua & sucrose laurate Hydrogenated polyisobutene 8 Pectin 1 Magnesium aluminium silicate 5.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium C14-C16 olefin sulfonate 2 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.15 Fragrance 0.25 PEG-40 hydrogenated castor oil 0.25

Example 15

(60) TABLE-US-00029 Composition % w/w Purified water QSAD 100 Sodium dilauramidoglutamide/lysine/ 0.10 water Hydrogenated polyisobutene 8 Magnesium aluminium silicate 3 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium C14-C16 olefin sulfonate 2 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 BPO 2.6 Citric acid 0.05

(61) Chemical stability of BPO in the composition of example 15 after storage 6 months at RT and 30° C. and 1 month at 40° C.:

(62) TABLE-US-00030 Storage Assay values per interval** conditions T0 T1M/T0 T2M/T0 T3M/T0 T6M/T0 RT 100 97.5 97.6 98.4 100.0 30° C. 91.7 91.0 40° C. 94.6 **Assay value = percentage of T0.

(63) Data indicated that BPO is chemically stable for 6 months at RT and 30° C. and 1 month at 40° C. in the formulation as described in example 15.

Example 16

(64) TABLE-US-00031 Composition % w/w Purified water QSAD 100 Glycerin& caprylic/capric triglycerides & 2 aqua & sucrose laurate Hydrogenated polyisobutene 8.0 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.10 Zinc gluconate 0.10 Sodium C14-C16 olefin sulfonate 2 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG 75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.15 Fragrance 0.25 PEG-40 hydrogenated castor oil 0.25

Example 17

(65) TABLE-US-00032 Composition % w/w Purified water QSAD 100 Glycerin& caprylic/capric triglycerides & 2 aqua & sucrose laurate Glycerin 4.95 Mineral oil 8 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.60 Zinc gluconate 0.40 Sodium C14-C16 olefin sulfonate 1 Decyl glucoside (55% in water) 3 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 BPO 2.6 Citric acid 0.15 Potassium sorbate 0.1 Benzyl alcohol 0.50

Example 18

(66) A comparative marketed formulation was tested. The qualitative composition is given in the table below and contains a mixture of classical emulsifiers such as PEG-100 stearate & glyceryl stearate and a cleansing surfactant, Disodium PEG-12 Dimethicone sulfosuccinate.

(67) TABLE-US-00033 Composition % Purified water N/A PEG-100 stearate & Glyceryl stearate Disodium PEG-12 dimethicone sulfosuccinate BPO Oil Additifs N/A—Not applicable

(68) TABLE-US-00034 Storage Assay values per interval** conditions T0 T1M T2M T3M RT 100 101.5 102.8 103.2 40° C. 83.2 64.5 49.3 **Assay value = percentage of T0.

(69) Contrary to the composition according to the invention, stability results show that the formulation containing BPO demonstrates acceptable chemical stability for 3 months at RT but is unstable after one month at 40° C.

(70) It has also been noted that the formulation is not a foaming composition contrary to the composition of the current invention.

Example 19

(71) TABLE-US-00035 Composition % w/w Purified water QSAD 100 glycerin & caprylic/capric triglycerides & 2 aqua & sucrose laurate Hydrogenated polyisobutene 8.0 Magnesium aluminium silicate 5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium C14-C16 olefin sulfate 2 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 5 Citric acid 0.15 Fragrance 0.25 PEG-40 hydrogenated castor oil 0.25

Example 20

(72) TABLE-US-00036 Composition % w/w Purified water QSAD 100 Glycerin & caprylic/capric triglycerides & aqua 2 & sucrose laurate Hydrogenated polyisobutene 8 Magnesium aluminium silicate 5 Xanthan gum 0.5 Sodium lauroyl methyl isethionate (85% purity) 2.5 Disodium EDTA 0.1 Poloxamer 124 0.2 propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 10 Citric acid 0.15

Example 21

(73) TABLE-US-00037 Composition % w/w Purified water QSAD 100 glycerin & caprylic/capric triglycerides & 2 aqua & sucrose laurate Hydrogenated polyisobutene 8.0 Bentonite 4.5 Xanthan gum 0.5 Dipotassium glycyrrhizate 0.25 Zinc gluconate 0.2 Sodium C14-C16 olefin sulfate 2 Disodium EDTA 0.1 Poloxamer 124 0.2 Propylene glycol 2 PEG-75 2 Phenoxyethanol 0.8 BPO 2.6 Citric acid 0.15 Fragrance 0.25 PEG-40 hydrogenated castor oil 0.25