Table 1 Component and R atios of BBC Cream Formulations Ingredient INCI name BBC-1 BBC-2 BBC-3 BBC-4 BBC-5 BBC-6 BBC-7 BBC-8 Vaseline Vaseline-white petrolatum 23 23 — — — — — — Paraffi n oil Paraffi n oil 8 8 — — — — — — Bees wax Bees wax 3,5 3,5 3,6 3,0 5 3,00 3,00 3,0 Arlacel 83 V Sorbitan sesquioleate 3 3 — — — — — — Oleum oil Olea Europaea oil 7,5 7,5 28 28 35 28 5 28 Lanolin Lanolin 1 1 2,5 2,5 6 2,5 2,5 2,5 BHT Butyl hydroxy toluene 0,02 0,03 0,03 0,01 0,01 0,03 0,01 0,01 Glycerine Glycerine 5 5 8 8 4,8 8,00 8 8 ZnO Zinc oxide 10 10 21 21 7,1 20,00 20 20 MgSO4.7HO2 Magnesium sulphate 1 1 1 1 — — 1 1 EDTA Etylenediaminetetraacetic acid 0,05 0,05 0,05 0,05 — — — 0,05 Deionized W. Deionized water 37,93 37,92 30.07 25,04 35,09 29,07 54,99 31,94 Shea butter Shea butter — — 0,75 0,75 — 0,75 0,75 0,75 Calendula oil Calendula oil — — 0,75 0,75 — 0,75 0,75 0,75 Dehylmus PGPH Polyglyceryl-2 Dipoly hydroxy stearate — — 4,25 4,00 — 4,00 4,00 4,00 Lameform TGI Polyglyceryl-3 Diiso stearate — — — 3,00 — 3,00 — — Boraks Sodium borax — — — 2,00 2,00 - — — Vitamin E Vitamin E — — — 0,50 — 0,50 — — D-panthenol Dex-panthenol — — — 0,40 — 0,40 — — Spermaceti Cety ester wax — — — — 5 — — — JOURNAL OF COSMETIC SCIENCE 178

NEXT-GENERATION NATURAL BABY BARRIER CREAM FORMULATIONS 179 fraction. Then, the required percentage amounts of surfactant were calculated according to the formula in the following text. Eight different cream formulations were prepared as mentioned earlier and prepared for 96 h at 4°C, and it was determined whether there was caking, creaming, and phase separation. The amount of required surfactant was calcu- lated according to the following formulation (24,25). 100 RHLB – HLB % = HLB – HLB B A A A % =100 – B A Microbiological anal ysis study. Microbiological analysis was performed for 96 h for all for- mulations. Samples that were sown on sheep blood agar were incubated for 4 d at 37°C, and it was checked whether the microorganism is produced. If there is microbial repro- duction as a result of incubation, further identifi cation must be performed for the deter- mination of the pathogen, which should not be included in the cosmetic legislation. Safety assessment study. This study attempts to evaluate the safety assessment of BBC and ingredients. BBCs are generally applied to the nappy area and mainly produce local expo- sure, although human systemic exposure may occur if each substance comes into contact with the mucous membrane of the oral cavity of the outer body of the human body. In the EU, United States, and Japan, the safety of BBCs is regulated under cosmetic and/or drug regulations. From this perspective, the exposure scenario of each substance in the cos- metic product was, respectively, evaluated, and the risk assessments were criticized (11,26). The amount of exposure to the components of cosmetic products is calculated from the singular concentration of each component in the fi nished product. It is necessary to cal- culate this exposure to assess the potential risk of raw materials. Individual exposure to the substances is calculated from the quantitative composition of the product. In the safety assessment made in cosmetic products, the exposure dose to the substances con- tained in the cosmetic product is expressed by the value of SED as mg/kg, body weight/d, and the calculation methods are given in the following text (26–28). * If the amount of dermal absorption (μg/cm2) on the unit surface is known, 2 –3 2 / × 1 0 / × × = 3.5 N Ng DAa g cm mg SSA cm F day–1 SED average newborn weight SED (mg/kg body weight/d): SED. DAa (μg/cm2): amount of derm al absorption at each cm2 on the skin surface. SSA: area of the skin surface that contacts with the fi nal product. NOAEL: results of tests which include teratogenicity, carcinogenicity, and long-term repeated-dose chronic toxicity. * Calculation method if the d ermal absorption amount of the applied product is known in %.