NEXT-GENERATION NATURAL BABY BARRIER CREAM FORMULATIONS 183 SAFET Y ASSESSMENT RESULT OF OPTIMUM FORMULATION A saf ety assessment study of BBC-8 formulation was carried out according to the Annex I of Regulation (EC) No 1223/2009 guideline (29). BBC-8 formulation safety assessment results are given in the following text. Area of the skin which is in contact with the product: 200 cm2. Amoun t of applied cream: 0.05 g. Conta ct time and frequency: 30 s and two times. Norma l and reasonably foreseeable exposure route: diaper rash area and topical route (no involuntary exposure). Targe t group: infant and toddler. 3mg DAa – ×SSA cm2 ×f day –1 cm2 g SED= 3.5 average infant weight body  ¬ Ng ­×10 ž ® N –1 50000/200 g/cm2 × 10–3 mg/Ng × 200 cm2 × 2 day SED= 3.5 average newborn weight N SE D = 28.571 mg/kg. NOAEL MoS= × Conc.% p100 SED *MoS values of each raw material of BBC-8 formulation are given in Table 7. It was n ecessary to calculate this exposure to assess the potential risk of each sub- stance. Individual exposure to the substances was calculated from the quantitative composition of the product. When calculating dermal absorption, calculations were made with the assumption that 100% of the product will be absorbed as the worst exposure scenario. MoS (safety limits for all substances/MoS) values of all substances in the formulation are given in Table 7 all of the MoS values were above 230. It has Table 4 Particle size, PDI, and Zeta Potential (ζ) Results of BBC Formulations (n = 3) Name Particle size (nm) PDI Zeta potential (ζ) (mV) BBC-1 508 ± 49.91 0.481 ± 0.01 -35.2 ± 2.55 BBC-2 367.5 ± 40.83 0.491 ± 0.07 -31.8 ± 1.80 BBC-3 609.3 ± 10.20 0.512 ± 0.08 -9.5 ± 0.79 BBC-4 513.4 ± 77.15 0.541 ± 0.08 -20.2 ± 1.85 BBC-5 741.4 ± 19.74 0.545 ± 0.07 -23.2 ± 1.00 BBC-6 584.1 ± 36.42 0.619 ± 0.11 -26.6 ± 0.20 BBC-7 521.2 ± 5.10 0.490 ± 0.05 -25.6 ± 0.76 BBC-8 533.2 ± 6.93 0.370 ± 0.03 -30.9 ± 0.72

JOURNAL OF COSMETIC SCIENCE 184 been evaluated by developing BBCs as safe when used under normal or reasonably foreseeable conditions of use. DISCUSSI ON The phys icochemical analysis of eight different barrier cream formulations developed with natural raw materials was compared with each other via the literature. As a result of the studies, barrier cream formulations from ZnO and natural sources were optimized. As a res ult of the studies, barrier cream formulations containing raw materials obtained from ZnO and natural sources were tried to be optimized. Nowadays , one of the most important points while developing cosmetic products is to provide biocompatible, natural, and recyclable products for the consumer and environ- ment. In this context, formulations containing olive oil, beeswax, ZnO, and w/o-type emulsions were obtained with the help of an appropriate emulsifi er in a formula. Consid- ering the physicochemical properties of ZnO, it was determined that the carrying capac- ity of w/o-type emulsions is suitable compared with o/w-type emulsions. The pH values of all formulations prepared with natural raw materials have been determined with three repeated measurements made in the pH range of 6–7. Considering the rheological prop- erties of the developed BBC formulations, it was observed that BBC-1 and BBC-2 were very viscous as a result of the use of 23% Vaseline, and the rheological character was not pseudoplastic. BBC-3, BBC-4, BBC-6, and BBC-7 were also in a lotion appearance. In BBC-8, it has been observed that the rheological character creates a consistent graph in the face of shear stress applied viscosity values, and it is estimated that it will meet the desired properties both in terms of shelf life and user satisfaction. Zeta potential (ζ) is one of the second parameters to evaluate the stability of disperse systems. It was observed as the optimum value (-30.9 mV ± 0.72) among the formulations after three repeated mea- surements in barrier cream formulations. The PDI was found as 0.370 ± 0.03 for BBC-8 Table 5 90-D Room Temperature Stability Test Results in 25°C, 60% Humidity Conditions for BBC-8 Parameters 0 d 15 d 30 d 60 d 90 d Appearance Opaque Opaque Opaque Opaque Opaque Odor Odorless Odorless Odorless Odorless Odorless pH 7.26 7.20 7.19 7.16 7.10 Viscosity (%50 torque) 49.200 cp 49.185 cp 48.000 cp 47.100 cp 46.900 cp Table 6 90-D Accelerated Stability Test Results in 40°C, 75% Humidity Conditions for BBC-8 Parameters 0 d 15 d 30 d 60 d 90 d Appearance Opaque Opaque Opaque Opaque Opaque Odor Odorless Odorless Odorless Odorless Odorless pH 7.26 7.10 7.05 6.95 6.80 Viscosity (%50 torque) 49.200 cp 48.550 cp 47.200 cp 46.100 cp 44.600 cp