CETEARYL ALCOHOL
화장품에서 세테아릴알코올 (CETEARYL ALCOHOL)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?
세테아릴알코올(표준 INCI: CETEARYL ALCOHOL, CAS 번호: 8005-44-5)은 화장품 처방에서 주로 불투명화제, 에모리엔트, 유화제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.5–6%(적정 pH 2.5–10) 범위에서 안정적으로 처방됩니다.
7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스
각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건| 국가·규제 트랙 | 공식 고시 전성분 표기명 | 원클릭 복사 |
|---|---|---|
| ① 한국 (MFDS 화장품 한글 표준명) | 세테아릴알코올 | |
| ② 한국 구명칭 (개정 전 이력 · 301 리다이렉트) | — | — |
| ③ 유럽 (EU CosIng EC 1223/2009) | CETEARYL ALCOHOL | |
| ④ 미국 일반화장품 (US PCPC / MoCRA INCI) | CETEARYL ALCOHOL | |
| ⑤ 미국 OTC (FDA Active Ingredient Monograph) | — (비-OTC 일반 화장품 원료) | — |
| ⑥ 중국 (NMPA IECIC 표준 중문명) | 鲸蜡硬脂醇 | |
| ⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW) | セテアリルアルコール · [QD: セトステアリルアルコール] |
Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태
| 권역 | 규제 상태 | 배합 한도 | 제한 조건 및 1차 법원 출처 |
|---|---|---|---|
| 한국 (MFDS) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 유럽 (CosIng) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 미국 (FDA/CIR) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 중국 (NMPA) | 등재·허용 | GMP | IECIC Entry #3580 |
| 일본 (MHLW) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 아세안 (ACD) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
Layer 2 — 독성·안전성 평가 한도 (US CIR · EU SCCS MoS≥100 · CN IECIC 최고역사사용량)
「SCCS 안전 판정 상한」은 유럽 소비자안전과학위원회가 안전역(MoS≥100)으로 판정한 상한이며, 「CIR 시판 보고 농도」와 「중국 IECIC 최고역사사용량」은 실제 시판 제품에 보고된 최대 농도입니다.
| 안전성 평가 기준 | 적용 부위·유형 | 안전 농도 범위 | 판정 결과 및 문헌 번호 |
|---|---|---|---|
| 중국 IECIC 최고역사사용량 | leave_on | ≤ 15% | 안전 판정(MoS≥100)NMPA IECIC (2025) Entry 03505 (2025) |
| 중국 IECIC 최고역사사용량 | rinse_off | ≤ 12% | 안전 판정(MoS≥100)NMPA IECIC (2025) Entry 03505 (2025) |
Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조
Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드
| 제형군 분류 | Min – Q1 – Median – Q3 – Max (%) | 처방 역할 및 기전 | Source ID |
|---|---|---|---|
| 제형군 B — 유화 로션 · 에멀전 · 크림 (O/W · W/O) | 0.5% · 1.5% · 2.5% · 3.8% · 6% | 유화 액정 골격 형성·점도 상승 및 유화 안정화 고급지방알코올 | Evonik TEGO Alkanol 1618 / Sasol NAFOL 1618 TDS & CIR |
| 제형군 C — 세정 워시오프 · 폼 · 샴푸 · 바디워시 | 1% · 2.5% · 4% · 5.5% · 8% | 헤어 컨디셔너·트리트먼트 라멜라 점증 및 모발 코팅 | CIR Cetearyl Alcohol Safety Assessment |
| 제형군 E — 무수 오일 · 멀티밤 · 립케어 | 0.5% · 2% · 3% · 4% · 22% | 무수 밤·스틱·오일 처방 유상 골격 및 보습막 형성 | Global Starter Formulation Library Statistical Distribution (n=19, EVONIK 11 · ELEMENTIS 3 · GRANT 3 · SEPPIC 2) |
| 제형군 A — 수성 토너 · 세럼 · 고농축 앰플 | 0.2% · 0.575% · 1% · 1.75% · 3% | 수성 세럼·토너·하이드로겔 처방 베이스 및 기능성 부여 | Global Starter Formulation Library Statistical Distribution (n=10, EVONIK 5 · ELEMENTIS 3 · GRANT 2) |
| 제형군 D — 자외선차단제(선크림) · 색조 · 파운데이션 | 0.1% · 0.6% · 1% · 2% · 5% | 선케어·색조 메이크업 분산 안정화 및 발림성 조절 | Global Starter Formulation Library Statistical Distribution (n=41, EVONIK 27 · GRANT 10 · ELEMENTIS 3 · SEPPIC 1) |
각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션
단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.
pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동
권장 구간 밖(pH < 2.5 또는 pH > 10)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.
최대 85°C 가열 공정에서 열적 안정성이 유지됩니다.
세포·분자 타깃 작용 기전 플로우 다이어그램
권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도
🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.
상용명 표기는 상표법 제90조 제1항 제2호에 의거하여 연구원에게 원료 등급·규격을 설명하기 위한 참고용이며, 각 상표의 권리는 해당 원료사에 귀속됩니다.
학술·독성·제형 종합 요약 (Tier 1~3 탄력 요약)
Tier 1 Synthesis이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.
근거 동료심사 학술 논문 (미국 NIH PubMed) (12)
Allergens in ophthalmic medicaments in New Zealand [PMID: 39714014 · 2025]
Eyelid allergic contact dermatitis (ACD) attributed to ophthalmic medications is often underreported, which can result in poor outcomes. Patch testing for eyelid ACD requires up-to-date knowledge of potential allergens. The aim of this study was to investigate allergens in ophthalmic medicaments in New Zealand. We conducted a cross-sectional review of ophthalmic medicaments available in New Zealand in October 2023. Prescription and over-the-counter products were catalogued with their respective ingredient lists according to product data sheets. Products unapproved for use as per Section 29 of the Medicines Act 1981, or that were unavailable for purchase were excluded. Ingredients were classified according to their function. Allergens in the New Zealand Baseline Series Extended (NZBSE) were recorded. Seventy-three topical ophthalmic medicaments were identified with a total of 143 formulations (brands). Twenty-eight formulations were excluded, leaving a total of 67 topical medicaments (115 formulations) for analysis. Fifty-eight per cent of formulations contained at least one NZBSE allergen. The most frequently identified NZBSE allergen was benzalkonium chloride (contained in 48% of formulations), followed by propylene glycol (6%), lanolin (4%), parabens (4%), caine anaesthetics (2%), neomycin sulphate (2%), and cetearyl alcohol (1%). The majority of ophthalmic preparations contain known allergens. Patch test series must be based on local data and revised regularly to ensure the diagnostic accuracy of patch testing. Patch testing patient's own products is imperative.
Do hypoallergenic skincare products contain fewer potential contact allergens? [PMID: 38069640 · 2024]
Personal care products (PCPs) commonly cause allergic contact dermatitis (ACD). Skincare companies often market their products as 'hypoallergenic'; however, this term is not regulated by industry standards. To determine whether PCPs marketed as hypoallergenic are truly less likely to precipitate ACD, we conducted a study of ingredients found in 'hypoallergenic PCPs' from two major UK retailers in 2022. Of 208 products meeting the inclusion criteria, 153 (73.6%) contained at least 1 allergen or related chemical from the British Society for Cutaneous Allergy baseline series, 21 (10.1%) had 2 potential allergens and 4 PCPs (1.9%) had 3 allergens. Cetearyl alcohol was the most common -allergen identified in leave-on PCPs and parabens in rinse-off products; fragrance was the most frequent related chemical found in 85 PCPs (40.1%). A high prevalence of common allergens was found in hypoallergenic PCPs, suggesting that dermatologists and consumers should be cautious of product ingredients.
Development and quality assessment of glutathione tripeptide loaded niosome containing carbopol emulgels as nanocosmeceutical formulations [PMID: 37119885 · 2023]
This study focuses on the preparation, physicopharmaceutical and mechanical characterization of reduced glutathione tripeptide loaded niosome containing emulgels as a novel nanocosmeceutical product. Prepared emulgel formulations were mainly composed of oily phase containing different lipids such as glycerine dibehenate, cetyl alcohol, cetearyl alcohol, etc., and aqueous phase containing Carbopol934® as gelling agent. Niosomal lipidic vesicles prepared from Span 60 and cholesterol were subsequently incorporated into optimum emulgel formulations. The pH, viscosity, and textural/mechanical properties of emulgels were examined before and after the incorporation of niosomes. The viscoelasticity and morphological characterization were performed on the final formulation before the packed formulation's microbiological stability test. The hardness and compressibility results ensured easy removal of the emulgel from the container. Due to the carboxyl groups of Carbopol934®, moderate adhesiveness with good cohesiveness was achieved. The rheological characteristics of the emulgels were estimated by oscillatory testing and the data fitted with the Herschel-Bulkley model. Thus, the viscoelastic properties and shear-thinning flow of emulgels were demonstrated. The final formulation was microbiologically stable, and pathogens or skin-irritating allergens were not detected. An anti-aging cosmeceutical preparation containing glutathione tripeptide loaded lipid-based niosome dispersion, suitable for topical use due to its textural and viscosity properties, was successfully produced.
Residual film formation after emulsion application: Understanding the role and fate of excipients on skin surface [PMID: 32464232 · 2020]
This study focuses on the fate of excipients contained in topical emulsions once applied on the skin. The aim was thus to develop a methodology to characterize the residue left on the skin shortly after emulsion application. To this end, both the role and the impact of the different excipients on the formation and properties of the residue left on the skin surface once a product is applied were investigated. To that purpose, an O/W emulsion composed of an ester as oily phase, an emulsifier (alkylpolyglucoside-based vehicles), a polymer and a humectant (hydrophilic excipient) was first developed. Then, systems with fewer ingredients were prepared to understand their respective role in the residual film. This residual film was studied in vivo by means of biophysical instrumental methods, all being performed on the participants' forearm. Results highlighted the major role of the ester giving a bright and hydrophobic residue. While the surfactant structuration as the presence of glycerin and polymer provided a specific water distribution inside the residue on the skin surface. Finally, this work evidenced the ingredients organization in the residue depending on the systems composition, with a particular stratification on skin surface which could be considered in the formulation strategy for efficient active delivery and skin protection.
Allergic contact dermatitis caused dexpanthenol-But is that all? [PMID: 31231804 · 2019]
Cetearyl isononanoate, an underestimated contact allergen? [PMID: 29785791 · 2018]
Confocal Raman microspectroscopy as an alternative to differential scanning calorimetry to detect the impact of emulsifiers and formulations on stratum corneum lipid conformation [PMID: 29775655 · 2018]
The purpose of this study was to investigate the impact of emulsifiers and formulations on stratum corneum (SC) lipid conformation and evaluate confocal Raman microspectroscopy (CRM) as an alternative method to differential scanning calorimetry (DSC) in this research context. To this end, four different formulations were used: three conventional creams that contained ionic and/or non-ionic emulsifiers and one surfactants-free emulsion stabilized by a polymeric emulsifier. Additionally, all emulsifiers were tested in aqueous solutions/dispersions in the respective concentrations as present in the formulations. In this study, emulsifiers and formulations were applied onto excised porcine skin during incubation in Franz diffusion cells. Subsequently, SC was isolated, dried and subjected to CRM and DSC measurement to analyse lipid structural changes after treatment. In CRM measurement, 1080 cm -1 /(1130 cm -1  + 1070 cm -1 ) peak ratio, which represents the C-C skeleton vibration and trans-gauche conformation order of lipids, was investigated. Various emulsifiers and formulations showed different impact on SC lipid conformation. Specifically, cetearyl alcohol and sodium cetearyl sulfate mixture dispersion showed the strongest ability among all studied emulsifiers, followed by glycerol monostearate, polyoxyethylene-20-glycerol monostearate as well as their mixture. Polysorbate 60, cetyl stearyl alcohol and their mixture did not affect SC lipid structure. The results of CRM and DSC correlated very well, indicating CRM, as an alternative to DSC, can be a reliable method to investigate SC lipid conformation.
Allergic contact dermatitis caused by sodium cetearyl sulfate [PMID: 29464717 · 2018]
Allergenic Ingredients in Facial Wet Wipes [PMID: 28338538 · 2017]
Allergic contact dermatitis commonly occurs on the face. Facial cleansing wipes may be an underrecognized source of allergens. The aim of this study was to determine the frequency of potentially allergenic ingredients in facial wet wipes. Ingredient lists from name brand and generic facial wipes from 4 large retailers were analyzed. In the 178 facial wipes examined, a total of 485 ingredients were identified (average, 16.7 ingredients per wipe). Excluding botanicals, the top 15 potentially allergenic ingredients were glycerin (64.0%), fragrance (63.5%), phenoxyethanol (53.9%), citric acid (51.1%), disodium EDTA (44.4%), sorbic acid derivatives (39.3%), tocopherol derivatives (38.8%), polyethylene glycol derivatives (32.6%), glyceryl stearate (31.5%), sodium citrate (29.8%), glucosides (27.5%), cetearyl alcohol (25.8%), propylene glycol (25.3%), sodium benzoate (24.2%), and ceteareth-20 (23.6%)/parabens (23.6%). Of note, methylisothiazolinone (2.2%) and methylchloroisothiazolinone (1.1%) were uncommon. The top potential allergens of botanical origin included Aloe barbadensis (41.0%), chamomile extracts (27.0%), tea extracts (21.3%), Cucumis sativus (20.2%), and Hamamelis virginiana (10.7%). Many potential allergens are present in facial wet wipes, including fragrances, preservatives, botanicals, glucosides, and propylene glycol.
The current spectrum of contact sensitization in patients with chronic leg ulcers or stasis dermatitis - new data from the Information Network of Departments of Dermatology (IVDK) [PMID: 28194803 · 2017]
Patients with lower leg dermatitis, chronic venous insufficiency or chronic leg ulcers have a high prevalence of contact sensitization. To identify the current spectrum of contact allergens in these patients. Data of the Information Network of Departments of Dermatology on 5264 patients with the above diagnoses from the years 2003 to 2014 (study group) were compared with data on 4881 corresponding patients from 1994 to 2003 (historical control group) and with a current control group without these diagnoses (n = 55 510). Allergic contact dermatitis was diagnosed less frequently in the study group than in the historical control group (25.9% versus 16.9%; p < 0.001), and contact sensitization to most allergens had declined. The allergen spectrum, however, was largely unchanged. Important allergens are Myroxylon pereirae (balsam of Peru) (14.8% positive reactions), fragrance mix I (11.4%), lanolin alcohol (7.8%), colophonium (6.6%), neomycin sulfate (5.0%), cetearyl alcohol (4.4%), oil of turpentine (3.1%), and paraben mix (2.6%). Patch testing with additional series showed sensitization to Amerchol L-101 (9.7%), tert-butyl hydroquinone (8.7%), framycetin sulfate (5.0%), and gentamicin sulfate (3.1%). Topical preparations for treating the above-mentioned conditions should not contain fragrances, Myroxylon pereirae, and colophonium. The special allergen spectrum has to be considered in patch testing.
Grape Pomace Extract-Loaded Liposomes Enriched Cream Formulations for Skincare [PMID: 42072063 · 2026]
This study aims to develop and characterize novel dermatocosmetic formulations designed to hydrate the skin, improve its appearance, reduce wrinkles, and provide antioxidant, anti-ageing, antimicrobial, and anti-inflammatory benefits, along with potential protection against UVA and UVB radiation. The formulations contain the following ingredients: xanthan gum (0.5%), Calendula officinalis oil (5%), Argania spinosa oil (5%), Helianthus annuus oil (5%), liposomes containing a hydroalcoholic extract of pomace from local red or white grapes (2%), an olive oil-based emulsifier (6%), vitamin E (0.5%), cetearyl alcohol (3%), propylene glycol (8%), and purified water (up to 100%). The natural ingredients used in these formulations, i.e., the red or white grape pomace extract from the aforementioned Romanian varieties, the oils of Calendula officinalis , Argania spinosa , and Helianthus annuus , xanthan gum, and the olive oil-based emulsifier (Olliva), promote the concept of 'green cosmetics'. The use of liposomes to deliver bioactive substances from hydroalcoholic extracts allows the gradual release of active ingredients into the skin. An alternative for incorporating grape pomace extract into a cream-type matrix involves the use of liposomes. Liposomes loaded with red or white grape pomace extract were prepared using the thin-film hydration technique, followed by ultrasonication and extrusion. The obtained formulations were characterized using bio-physico-chemical analysis procedures in terms of consistency, colour, homogeneity, aroma, pH, stretch, texture, stability, and antioxidant activity/free radical scavenging capacity, as well as in vitro polyphenol release behaviour. These newly developed dermatocosmetic formulations were the subject of a patent application in Romania.
Spontaneous Emulsification as a Low-Energy Strategy for Designing and Optimizing Resveratrol-Loaded Nanostructured Lipid Carriers [PMID: 41768678 · 2026]
Nanostructured lipid carriers (NLCs) have proven to be effective for the delivery of lipophilic drugs by combining high encapsulation capacity with controlled release properties. In this study, NLCs were developed using spontaneous emulsification, a low-energy, simple method that is free of organic solvents. Cetearyl alcohol and Kolliphor RH 40 were employed as the solid lipid and surfactant, respectively. The formulation and process were optimized through a Box-Behnken design, considering mean particle size and size uniformity, as determined by laser diffraction. Colloidal stability was improved by the addition of sodium lauryl sulfate and adjustments to the dispersion polymer. Resveratrol (RVL), used as a model bioactive compound, achieved an encapsulation efficiency of 99%, with a mean particle size of 90 nm, a polydispersity index of 0.2, and a zeta potential of -37 mV, remaining stable for 90 days at 8 °C. Characterization by differential scanning calorimetry/thermogravimetry, Fourier transform infrared, and transmission electron microscopy confirmed the incorporation of the active compound as well as the composition and morphology of the nanocarriers. The system exhibited a delayed and sustained release of RVL, highlighting its potential as a platform for the delivery of bioactive compounds. Overall, the results demonstrate that spontaneous emulsification is a viable and sustainable alternative to the high-energy methods predominantly reported in the literature, enabling the production of stable and efficient NLCs for pharmaceutical and cosmetic applications.
자주 묻는 질문 (AEO 스니펫 최적화 FAQ)
- Q1. 세테아릴알코올 (CETEARYL ALCOHOL)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
- 한국 식약처 표준명은 '세테아릴알코올', 미국 PCPC 및 유럽 CosIng INCI 표기는 'CETEARYL ALCOHOL', 중국 NMPA IECIC 표준명은 '鲸蜡硬脂醇', 일본 화장품 표시명칭은 'セテアリルアルコール'입니다.
- Q2. 세테아릴알코올의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
- 한국(KR: none), 유럽(EU: none), 미국(US: none), 중국(CN: allowed), 일본(JP: none), 아세안(ASEAN: none) 고시 기준을 준수하여 처방해야 합니다.
- Q3. 제형 설계 시 세테아릴알코올의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
- 대표 제형군(emulsion_cream) 기준 통상 0.5~6%(권장 중앙값 2.5%) 범위로 투입하며, 적정 pH는 2.5~10입니다.
- Q4. 세테아릴알코올 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
- 주요 권장 시너지 조합은 CETEARYL GLUCOSIDE, GLYCERYL STEARATE, BEHENTRIMONIUM CHLORIDE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE이며, 배합 주의사항은 비이온성 공유화제로 전 pH 구간 안정하나, 급랭 시 후점도(Post-thickening) 변화가 있으므로 서서히 교반 냉각 권장입니다.