NEXT-GENERATION NATURAL BABY BARRIER CREAM FORMULATIONS 185 Table 7 MoS Calculations of BKF-8 (Highest Concentration for Each Raw Material) Ingredient Ratio NOAEL (mg/kg) MOS References Bees wax 3.0 250 291.67 230 (31) Olea Europea fruit oil 28 2,000 251 230 (32) Lanolin 2.5 1,200 1,680.02 230 (33) Butyl hydroxy toluene 0.01 250 87,501 230 (34) Glycerine 8 4,580 2,003.7 230 (35) Zinc oxide 20 2,000 350 230 (36) Magnesium sulphate 1 256 896 230 (37) Ethylene diamine tetra acetic acid 0.05 2,000 14,002 230 (38) Shea butter 0.75 1,000 4,666.7 230 (39) Calendula oil 0.75 2,500 11,666.8 230 (40) Polyglyceryl-2 dipoly hydroxy stearate 4.00 845 739.4 230 (41) Deionized water 27.59 — — — formulation as a result of three repeated measurements. These two values can be consid- ered as a reference point when creating an emulsion formulation to develop barrier cream formulations containing natural raw materials. BBC-8 formulation instability studies were performed at 25 ± 2°C temperature, 60% ± 5% humidity and 40°C ± 2 temperature, and 75% ± 5 humidity. Stability study was evaluated for color, odor, pH, viscosity, and appearance parameters (see Tables 5 and 6). It was not observed singifi cant change in BBC-8 formulation parameters. The MoS values of BBC-8 formulation ingredient were calculated using the NOAEL according to the literature. As a result of the calculations, it was determined that when the substances forming the formulation content are used in appropriate concentrations, all of them have the desired SED values (see Table 7). CONCLUSION From the results of the aforementioned studies, BBC-8 formulation was confi rmed as the most suitable according to the pH, viscosity, HLB, particle size, zeta potential (ζ), PDI, microbiological analysis, and stability studies. As a result of the stu dy, the MoS value was above 230 according to the calculations made on each component and in certain concentration ranges and this case it was concluded that the BBC-8 (K13/092) formulation is safe for babies when the legislation and regula- tions are examined. In terms of cosmetics in the future, it gives hope to consumers in the preparation of a barrier cream, and it provides a safer cosmetic product consisting of natural oils and zinc oxide without preservatives, perfumes, and dyes. ACKNOWLEDGMENTS The au t hors would like to thank the SFA R&D Laboratory (Istanbul, Turkey) and its general manager MSc. Bekir CAKICI for the valuable contribution to our research.
JOURNAL OF COSMETIC SCIENCE 186 REFERENCES (1) P. M. E lias, Strat u m corneum defensive functions: an integrated view, J. Invest. Dermatol., 125(2), 183– 200 (2005). (2) P. M. Elias, Struc t ure and function of the stratum corneum extracellular matrix, J. Invest. Dermatol., 132(9), 2131–2133 (2012). (3) S. Adalat, D. Wall , and H. Goodyear, Diaper dermatitis-frequency and contributory factors in hospital attending children, Pediatr. Dermatol., 24(5), 483–488 (2007). Figure 3. Result of the zeta potential (ζ) of the BBC-8 (K13/092) optimum formulation.
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