The document discusses several specialty humectant and moisturizer products from Colonial Chemical including Cola® Moist 200, Cola® Moist 200C, Cola® Moist 300P, and emulsifiers that are 1,4-dioxane free such as Cola® Fax CPO, Cola® Fax CPE, and Cola® Fax CPE-K. The products are described as effective humectants and moisturizers that can be used across a variety of personal care applications and formulations. They are highlighted as having properties such as being non-irritating to skin and eyes, stable over a wide pH range and temperatures, and providing moisturization without being
2. Cola ® Moist 200 Cola ® Moist 200C Cola ® Moist 300P
3. Cola ® Moist: A powerful humectant moisturizer for personal care.
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7. A New Generation of Humectants for Personal Care Applications Cola ® Moist 200
8. Glycerin A New Generation of Humectants for Personal Care Applications Cola ® Moist 200
9. A New Generation of Humectants for Personal Care Applications Cola ® Moist 200
10. A New Generation of Humectants for Personal Care Applications Cola ® Moist 200
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13. Cola ® Moist 200C Anhydrous Humectant Moisturizer
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15. Cola ® Moist 200C has been tested and is a safe material when used in combination with other personal care raw materials. MOISTURIZATION In order to test the effectiveness of Cola ® Moist 200C, a series of tests were run comparing Cola ® Moist 200C with well- known humectants and moisturizers. A selection of polyether chloride, hydroxyethyl urea, glycerin, sodium pyroglutamate (sodium PCA) and sodium lactate were all tested at various humidity levels in a humidity cabinet. Cola ® Moist 200C
17. TOXICITY Eye Cola ® Moist 200C was tested for eye irritation using the chorioallantois membrane technique (HET-CAM). Cola ® Moist 200C received a very low score indicating the product is non-irritating to the human eye. SKIN To evaluate the potential irritation to skin, a study was performed adhering to ICH Guideline E6 and 21 CFR parts 50 and 56. Fifty-Two (52) volunteers, males and females, ranging in age from 16 to 77 were subjected to a “patch test”. The “patch test” was performed with the Cola ® Moist 200C diluted to 5.0 % activity. A 3/4 X 3/4 absorbent pad was moistened with 0.2 ml of liquid and applied to the backs of the subjects between the scapulae. The patch sites were inspected at 48 hours for gross changes. It was observed that there was a complete absence of skin change. The test sites were evaluated again at 72 hours. Once again the observation was negative skin changes. Under the conditions of this test, Cola ® Moist 200C did not indicate a potential for dermal irritation. Colonial Chemical does not animal test. Cola ® Moist 200C
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19. Cola ® Moist 300P POLYMERIC HUMECTANT & MOISTURIZER
38. Cola ® Fax CPE VISCOSITY RESPONSE Figure 1 demonstrates the effect Cola ® Fax CPE has on emulsion viscosity. At low concentrations, Cola ® Fax CPE will effectively increase viscosity and aid in the stabilization of the emulsion system. Formulations containing Cola ® Fax CPE will display enhanced shear, heat and freeze-thaw stability. Cola ® Fax CPE will also enhance the glossy appearance of cosmetic creams. TEST SYSTEM % by Wt. Water q.s. Glycerin 5.0 Potassium Hydroxide (45%) 0.33-1.34 Germaben II-E 0.5 Cetyl Alcohol 2.0 Myristyl Myristate 2.0 Isopropyl Palmitate 2.0 Cola ® Fax CPE 0.5-2.0 TOTAL 100.0 Emulsion pH 7.0
40. TYPICAL PROPERTIES Appearance Waxy White Flake % Solids 100 pH (10% in 50/50 IPA/Water) <2 Melting Point 61°C Specific Gravity (25°C) 1.02 Acid Value (pH 5.0) 200 TOXICOLOGICAL PROPERTIES Dermal Evaluation (3% in water pH 7.0) 48 Hour 25/25 Completely Non-Irritating Human Patch 25 Test Subjects In Vitro Ocular Evaluation (3% in water pH 7.0) Ropak, Eytex TM Rapid Membrane Assay Eyetex TM Classification: Minimal/Mild Cola ® Fax CPE
41. Cola ® Fax CPE 100.0 Total 0.5 Lanolin Alcohol 1.0 Dimethicone (100cS) 4.0 Isopropyl Palmitate 3.0 Myristyl Myristate 2.0 Cetyl Alcohol % by Weight Part C 0.5 Titanium Dioxide % by Weight Part B 0.6 Germaben II-E 2.5 Cola ® Lipid ST 1.0 Cola ® Fax CPE 0.4 Potassium Hydroxide (45%) 84.5 Water Procedure: Heat Part A with agitation to 60°C, add Part B, continue mixing. Separately heat Part C to 60°C. Homogenize C into Part A for a sufficient time to ensure good emulsification. Stir, cool to 45°C, add fragrance, and package. % by Weight Part A Deep Moisturizing Cream
42. Skin Care Lotion Compound Wt.% Phase A. Water 82.8 Cola ® Lipid DLO 3.0 Cola ® Teric CDCX-LV 1.0 Glycerin 5.0 Titanium dioxide 0.5 Triethanolamine 0.7 Phase B. Cola ® Fax CPE 1.0 Isopropyl palmitate 3.0 Cetyl alcohol 2.0 Dimethicone, 350 cs. 1.0 Preparation: Combine each phase separately and apply sufficient heat with stirring to liquefy Phase B completely. Homogenize Phase B into Phase A while maintaining heat, after emulsion is formed, stir-cool to 45°C, add fragrance, color, and preservative, then package.
43. Odorless Cream Relaxer Part A: COMPOUND WT. % Cola®Fax CPE 3.5 Stearyl Alcohol 3.5 Petrolatum 10.0 Mineral Oil 25.0 Part B: Cola®Lipid ST 3.0 Propylene Glycol 2.0 Water 48.0 Potassium Hydroxide (45%) 5.0 TOTAL 100.0 PROCEDURE: Heat Part A with agitation to 70oC. Separately heat Part B to 60oC. Homogenize Part B into Part A for an adequate amount of time to ensure good emulsification. Stir cool to 45oC. Then add fragrance and preservative. TYPICAL PROPERTIES: Appearance White creme pH 13
49. Cola ® Lipids The ColaLipid products are multifunctional, natural oil derived phospholipids composed predominantly of diester and triester phosphatides. Through the careful selection of specific natural oils and fatty acids as raw materials, the ColaLipid products deliver a broad range of functional properties which include gentle cleansing, anti-irritation effects, unusually high substantivity, long lasting conditioning, broad spectrum antimicrobial activity, emulsification attributes, and exceptional mildness to skin and eyes. While certain ColaLipid products exhibit antimicrobial properties, they are not registered antimicrobials. ColaLipid C is particularly useful to augment the efficacy of standard antimicrobial agents. Due to the ampholytic character of the ColaLipid products, they are compatible with virtually all other types of ingredients including anionic surfactants. The ColaLipid products have multiple hydrophobic groups, as well as multiple cationic binding sites, which provide unusually high degrees of substantivity. Many of the ColaLipids , acted upon by specific skin enzymes, can serve as delivery systems for essential fatty acids that the body requires but is not able to synthesize. These essential fatty acids, linoleic and linolenic acids, reinforce and repair the skin barrier function and alleviate dry, damaged skin conditions. They enhance skin moisturization and do not interfere with normal skin respiration. The non-irritation toxicological properties of the ColaLipids , combined with their broad spectrum antimicrobial activity, is highly unique and permits their use in a variety of opthalmic and skin treatment formulations. Their ability to effectively kill gram-negative organisms is a highly desirable formulation benefit, not generally achievable with quaternary surfactants. Description
58. Cola ® Lipid C DESCRIPTION Cola®Lipid C , chemically described as Cocamidopropyl Phosphatidyl PG-Dimonium Chloride, is a coconut oil derived phospholipid composed predominantly of diester and triester phosphatides with multiple chain groups. In addition to topically simulating the properties displayed by the polar stratum corneum lipids, Cola®Lipid C displays a broad range of functional attributes including gentle cleansing and foaming properties, anti-irritation effects when combined with anionic surfactants, unusually high substantivity, long lasting skin conditioning, and broad spectrum antimicrobial activity. Due to the ampholytic character of Cola®Lipid C , it is compatible with practically all other types of ingredients including anionic surfactants. Because Cola®Lipid C possesses this unique combination of properties and is virtually non-irritating to skin and eyes, it is an ideal ingredient for baby care products, sensitive skin cleansers and other personal care and health care products. ANTIMICROBIAL PROPERTIES Cola®Lipid C can be used to reduce or eliminate the use of classical preservatives to achieve self-preservation strategies with improved skin health benefits. Its performance is not adversely affected by solution pH, anionic or nonionic surfactants, or typical preservative deactivators . CTFA/INCI Name : Cocamidopropyl PG-Dimonium Chloride Phosphate CAS # 83682-78-4 EINECS # 280-518-3
60. Cola ® Lipid C TYPICAL PROPERTIES TYPICAL FORMULATIONS TOXICOLOGICAL PROPERTIES Dermal (5% in water) 48 Hour Occluded Human Patch - 50 Test Subjects 48/50 Completely Non-Irritating 2/50 Barely Perceptible Erythema Ocular (3% in water) InVitro Int. Eytex Rapid Membrane Assay Classification Minimal/Mild Sensitization (5% in water) Repeated Insult Occluded Patch - 50 Test Subjects No evidence of induced allergic contact dermatitis in humans Cola®Lipid C is approved for use under CFR.21,176.210. 47.0 % Total Solids 1.03 Specific Gravity (25°C) 7.0 pH (10% Solution) Clear Yellow Liquid Appearance Procedure: Add ingredients, adjust pH 5.5-6.0 Procedure: Add ingredients, adjust pH to 5.5 100.0 57.5 Water 100.0 28.0 Colonial SLES-2 98.6 Water 12.0 Cola ® Teric CDCX 50 0.4 Malic Acid 2.5 Cola ® Lipid C 1.0 Cola ® Lipid C % by weight % by weight Sensitive Skin Cleanser Baby Wipe
61. Cola ® Lipid C TEST RESULTS FOR SUSTAINED ANTIMICROBIAL ACTIVITY ON FIBER* Procedure: Swatches of an air-laid cellulosic / cotton blend were exposed to the test material by dipping into the test solution and blotting to remove excess moisture. Imprints were then made on seeded agar plates (inoculated with S. Epidermidis). The swatches were then rinsed and blotted to remove excess moisture. A series of four rinsings and imprints were made, including the initial exposure and imprint. The degree of residual activity / fiber substantivity was determined by the clarity of the zone of inhibition to microbe growth surrounding the imprints and the seeded agar plates as compared to the untreated controls. The grading system used to record the data obtained is as follows: Excellent control of microbial growth 4 Good 3 Moderate 2 Slight 1 No control of microbial growth 0 Antimicrobial activity Grade 0.3 0.3 Untreated control 2.8 2.7 Rinse 3 3.3 3.0 Rinse 2 4.0 4.0 Rinse 1 4.0 4.0 Initial exposure 3% test material as supplied 1% test material as supplied Swatch (2x2 cm)
62. Cola ® Lipid C TEST RESULTS FOR SUSTAINED ANTIMICROBIAL ACTIVITY ON SKIN* Procedure: Individual fingers of selected panelists were washed twice, blotted to remove excess moisture, and exposed to the test material. Finger imprints were then made on seeded agar plates (inoculated with S. Epidermidis), after which the individual fingers were rinsed and blotted. A series of three rinsings and four imprints were made, including the initial exposure and imprint. The degree of residual antimicrobial activity on the skin was determined by the clarity of the zone of inhibition to microbial growth surrounding the imprints on the seeded agar plates. The grading system used to record the data is identical with that described above. * As reported in Cosmetics and Toiletries Manufacture Worldwide, 1994 1.3 1.3 1.3 Untreated 2.0 1.3 1.3 Rinse 3 2.3 2.0 1.0 Rinse 2 3.0 2.6 1.6 Rinse 1 4.0 4.0 2.0 Initial exposure 5% test material as supplied 3% test material as supplied Control Soap only
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66. Colonial Monolaurin TYPICAL PROPERTIES White flake or white powder Appearance: Approximately 59 C - 60°C Melting point: Maximum 1.5% Free fatty acid: Maximum 4%; Free glycerol: 200-210 Saponification value: Maximum 1 Iodine value: Myristic: max. 8% Capric: max. 2%, Lauric: min. 90%, Fatty acid composition: Minimum 90% *Monoester content:
67. Colonial Monolaurin CLEAR EAR WITH MONOLAURIN – Designed for pets as an ear wash, Colonial Monolaurin helps soothe the ear and provides mildness to the formulation. Product is a lightly viscous fluid with a very slight haze. Use as a miticide for animal ears. 100.00 TOTAL 1.00 Phenoxyethanol 1.00 Benzyl alcohol 0.50 Colonial Monolaurin 37.50 Glycerin 60.00 Propylene glycol WT. % COMPONENT
68. Colonial Monolaurin COLONIAL MONOLAURIN LIGHT MOISTURIZING HAND CREAM WITH PCMX Phase 1 WT.% Deionized water 82.44 Glycerin 5.00 EDTA (Na2) 0.10 Berberine 0.01 Phase 2 Dimethicone 4.00 Varisoft TA-100 2.50 Cetyl Alcohol 2.00 Colonial Monolaurin 3.00 Cola®Mulse PCMX 0.50 Phase 3 Lemon Oil 0.25 Vitamin E 0.20 TOTAL 100.00 Procedure Blend ingredients in Phase 1 as given with stirring and heat to 60oC – 70oC. Blend ingredients in Phase 2 with stirring and heat sufficiently to melt all waxes. Add Phase 2 to Phase 1 with sufficient agitation to create a homogenous blend. Stir-cool to 40oC and then add Phase 3 ingredients.
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70. Skin Care Lotion Compound Wt.% Phase A. Water 82.8 Cola ® Lipid DLO 3.0 Cola ® Teric CDCX-LV 1.0 Glycerin 5.0 Titanium dioxide 0.5 Triethanolamine 0.7 Phase B. Cola ® Fax CPE 1.0 Isopropyl palmitate 3.0 Cetyl alcohol 2.0 Dimethicone, 350 cs. 1.0 Preparation: Combine each phase separately and apply sufficient heat with stirring to liquefy Phase B completely. Homogenize Phase B into Phase A while maintaining heat, after emulsion is formed, stir-cool to 45°C, add fragrance, color, and preservative, then package.
71. Odorless Cream Relaxer Part A: COMPOUND WT. % Cola®Fax CPE 3.5 Stearyl Alcohol 3.5 Petrolatum 10.0 Mineral Oil 25.0 Part B: Cola®Lipid ST 3.0 Propylene Glycol 2.0 Water 48.0 Potassium Hydroxide (45%) 5.0 TOTAL 100.0 PROCEDURE: Heat Part A with agitation to 70oC. Separately heat Part B to 60oC. Homogenize Part B into Part A for an adequate amount of time to ensure good emulsification. Stir cool to 45oC. Then add fragrance and preservative. TYPICAL PROPERTIES: Appearance White creme pH 13