원료 사전 탐색/cetyl-alcohol/CETYL ALCOHOL
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
합성 (Synthetic)

CETYL ALCOHOL

식약처 한글 표준명: 세틸알코올
향료불투명화제에모리엔트유화제유화안정제거품증진제세정제점도조절제
[식약처 공정서 기원 및 정의] 이 원료는 주로 다음의 구조를 갖는 지방알코올이다.
결론 선행 Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

화장품에서 세틸알코올 (CETYL ALCOHOL)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?

세틸알코올(표준 INCI: CETYL ALCOHOL, CAS 번호: 36653-82-4)은 화장품 처방에서 주로 향료, 불투명화제, 에모리엔트 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.2–2%(적정 pH 4–8) 범위에서 안정적으로 처방됩니다.

7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스

각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건
7-Track Official Statutory Label Names for CETYL ALCOHOL
국가·규제 트랙공식 고시 전성분 표기명원클릭 복사
① 한국 (MFDS 화장품 한글 표준명)세틸알코올
② 한국 구명칭 (개정 전 이력 · 301 리다이렉트)——
③ 유럽 (EU CosIng EC 1223/2009)CETYL ALCOHOL
④ 미국 일반화장품 (US PCPC / MoCRA INCI)CETYL ALCOHOL
⑤ 미국 OTC (FDA Active Ingredient Monograph)— (비-OTC 일반 화장품 원료)—
⑥ 중국 (NMPA IECIC 표준 중문명)鲸蜡醇
⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW)セタノール · [QD: セタノール]

Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태

Layer 1 Statutory Regulatory Limits Across 6 Regions for CETYL ALCOHOL
권역규제 상태배합 한도제한 조건 및 1차 법원 출처
한국 (MFDS)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
유럽 (CosIng)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
미국 (FDA/CIR)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
중국 (NMPA)등재·허용GMPIECIC Entry #3526
일본 (MHLW)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
아세안 (ACD)미규제GMP공식 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.

Layer 2 Toxicological & Historical Safe Use Concentrations for CETYL ALCOHOL
안전성 평가 기준적용 부위·유형안전 농도 범위판정 결과 및 문헌 번호
중국 IECIC 최고역사사용량leave_on≤ 15%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 03495 (2025)
중국 IECIC 최고역사사용량rinse_off≤ 10%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 03495 (2025)
⚠️ 참조용 안내 (법적 면책 공지): 이 사전의 성분명·규제 한도·배합 가이드는 연구·개발 참조용으로만 제공됩니다. 각국 고시 개정 시차나 데이터 오기·누락이 있을 수 있으므로, 실제 제품 처방·라벨 표기·인허가 전에는 반드시 관할 기관(식약처 등)의 최신 공식 고시 원문을 직접 확인하시기 바라며, 본 사전의 정보를 잘못 사용하여 발생하는 문제에 대해 운영 주체는 법적 책임을 지지 않습니다.
제형군별 사분위수(Min–Q1–Median–Q3–Max) 분포 그래프

Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조

수성 토너·세럼·앰플n=7
Min 0.2% · Q1 0.75% · Median 1% · Q3 1.5% · Max 2%
O/W · W/O 에멀전·크림n=14
Min 0.5% · Q1 0.6% · Median 0.6% · Q3 0.9375% · Max 1.2%
자외선차단·색조n=8
Min 0.55% · Q1 1% · Median 1% · Q3 1.25% · Max 3%
수성 토너·세럼·앰플 — 수성 세럼·토너·하이드로겔 처방 베이스 및 기능성 부여
공식 검증 원천: Global Starter Formulation Library Statistical Distribution (n=7, GRANT 7) (cir_safety) · GRANT 7
권장 중앙값: 1%

Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드

Layer 3 Formulation Concentration Quartiles by Product Category for CETYL ALCOHOL
제형군 분류Min – Q1 – Median – Q3 – Max (%)처방 역할 및 기전Source ID
제형군 A — 수성 토너 · 세럼 · 고농축 앰플0.2% · 0.75% · 1% · 1.5% · 2%수성 세럼·토너·하이드로겔 처방 베이스 및 기능성 부여Global Starter Formulation Library Statistical Distribution (n=7, GRANT 7)
제형군 B — 유화 로션 · 에멀전 · 크림 (O/W · W/O)0.5% · 0.6% · 0.6% · 0.9375% · 1.2%유화 로션·크림 제형 구조 형성 및 피부 컨디셔닝Global Starter Formulation Library Statistical Distribution (n=14, GRANT 13 · SEPPIC 1)
제형군 D — 자외선차단제(선크림) · 색조 · 파운데이션0.55% · 1% · 1% · 1.25% · 3%선케어·색조 메이크업 분산 안정화 및 발림성 조절Global Starter Formulation Library Statistical Distribution (n=8, GRANT 6 · ELEMENTIS 1 · SEPPIC 1)
피부 투과 과학 시각화 (Bos & Meinardi 500 Dalton Rule)MW: Macro/Complex · LogP: N/A

각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션

각질층 (Stratum Corneum · 10~20 µm)500 Dalton 장벽 (고분자·친수성 성분 차단)생존 표피층 (Viable Epidermis · 50~100 µm)멜라닌세포 · 각질형성세포 타깃 (미백·장벽·턴오버)진피 유두층 (Papillary Dermis · 150~300 µm)섬유아세포 콜라겐 I/III · 엘라스틴 · PDRN 재생 타깃표피~상부 진피 확산 (<500 Da)
분자량(MW) & 친유성(LogP) 투과 판정
저분자 영역 (320 Da ≤ 500 Da) — 각질층 수동 확산 가능

단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.

예상 도달 깊이
40–90 µm
권장 전달 시스템
Polyol Enhancer / Serum
계면화학 · pH · 열역학 공정 시각화

pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동

Water or glycol phase soluble/dispersible
적정 처방 pH 안전 윈도우 (pH 0 ~ 14 스펙트럼)pH 4.0 – 8.0
0245.5791114

권장 구간 밖(pH < 4 또는 pH > 8)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.

공정 가열 한계 온도 (Max Process Temp)≤ 50°C
25°C45°C60°C75°C85°C100°C

최대 50°C 가열 공정에서 열적 안정성이 유지됩니다.

계면활성·유화 HLB 스펙트럼 (0 ~ 20) & 미셀/액정 배열 시뮬레이터
O/W 수중유형 미셀 에멀전 (수분 크림·로션)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
생화학 신호전달 경로 (Biochemical Pathway Map)

세포·분자 타깃 작용 기전 플로우 다이어그램

1. 각질층·표피 작용→ 촉진·활성 (Activation)
각질층 세포간 지질 & 수분 결합 네트워크
→
경피수분손실(TEWL) 억제 및 피부결 개선
2. 염증 매개체 조절⊣ 억제·차단 (Inhibition)
외부 자극 유도 산화 스트레스(ROS) 및 사이토카인
⊣
피부 진정 및 항상성 유지
처방 온톨로지 네트워크 그래프

권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도

+ GLYCERIN+ CAPRYLIC/CAPRIC TR…+ TOCOPHEROL✕ 처방 내 극단적 pH 조건 및 고농도…CETYL ALCOHOL
노드 인터랙션 가이드

🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.

대표 상용명 참고 (상표법 제90조 제1항 제2호 설명적 표기)
CETYL ALCOHOL

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 Synthesis

이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.

■ [1. 화학적 정체성 및 규격 (Chemical Identity & Standard Nomenclature)] - 표준명: 세틸알코올 | INCI: CETYL ALCOHOL | CAS No.: 36653-82-4 | EC No.: 253-149-0 - 기원 및 분류: SYNTHETIC | 주요 기능: 향료, 불투명화제, 에모리엔트, 유화제, 유화안정제, 거품증진제, 세정제, 점도조절제 - 물리화학 스펙: 분자식 복합 조성이거나 단일 화학식 미지정 | 분자량 고분자/복합물(Polymer/Complex) | 친수/친유 밸런스 특화 | 이온성: non-ionic | CosIng/MFDS 등재 - 7대 권역 공식 라벨 표기: KR [세틸알코올] · EU [CETYL ALCOHOL] · US [CETYL ALCOHOL] · CN [鲸蜡醇] · JP [セタノール] · JP의약부외품 [セタノール] ■ [2. 피부과학적 작용 기전 및 제형 내 역할 (Mechanism of Action & Function)] - 이 원료는 주로 다음의 구조를 갖는 지방알코올이다. 물리화학적 분류상 기원(synthetic)에 기반하여 피부 장벽 및 제형 매트릭스 내에서 고유한 기능(향료, 불투명화제, 에모리엔트, 유화제, 유화안정제, 거품증진제, 세정제, 점도조절제)을 수행하며, 계면 안정화·보습·피부 컨디셔닝 또는 유효성분 전달에 기여합니다. ■ [3. 글로벌 6대 권역 법정 규제 및 안전성 한도 (Layer 1 & Layer 2 Regulatory Matrix)] - 6개국 요약: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (중국 IECIC(2025) 등재번호 3526 (鲸蜡醇)) - 6대 주요 권역(KR·EU·US·CN·JP·ASEAN) 별도 배합금지/특수제한 고시 없음 (GMP 일반 안전 기준 내 배합 허용). - 공인 안전성·역사적 사용 농도(Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): 최대 15.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): 최대 10.0% ■ [4. 제형군별 통상 배합 가이드 (Layer 3-A Formulation Dosage Guide)] - [aqueous_serum] 권장 범위: 0.2 ~ 2.0% (중앙값 1.0%, 근거: Global Starter Formulation Library Statistical Distribution (n=7, GRANT 7)) — 수성 세럼·토너·하이드로겔 처방 베이스 및 기능성 부여 - [emulsion_cream] 권장 범위: 0.5 ~ 1.2% (중앙값 0.6%, 근거: Global Starter Formulation Library Statistical Distribution (n=14, GRANT 13 · SEPPIC 1)) — 유화 로션·크림 제형 구조 형성 및 피부 컨디셔닝 - [sun_color] 권장 범위: 0.55 ~ 3.0% (중앙값 1.0%, 근거: Global Starter Formulation Library Statistical Distribution (n=8, GRANT 6 · ELEMENTIS 1 · SEPPIC 1)) — 선케어·색조 메이크업 분산 안정화 및 발림성 조절 ■ [5. 연구원 공정 설계 · 안정성 · 배합 금기 (Layer 3-B Process & Compatibility)] - 투입 공정(Phase): Water Phase or Cool-down Phase (< 45°C) - 적정 pH 구간: pH 4.0 ~ 8.0 | 공정 내열 온도: 최대 50°C | 전해질(염) 내성: MEDIUM - 배합 주의/금기: 처방 내 극단적 pH 조건 및 고농도 전해질과의 상용성 사전 확인 권장 - 시너지 추천 원료: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | 참고 상용 원료명: CETYL ALCOHOL ■ [6. 학술 논문 및 공인 문헌 근거 (Peer-Reviewed Literature & Compendia)] - PMID 40978887 (2025, Cureus): Clinical Evaluation of a Soap-Free Cleansing Lotion Containing Sodium Cocoyl Apple Amino Acids for Effective Impurity Re - PMID 40672672 (2025, ACS Pharmacol Transl Sci): Propolis-Loaded Niosomes for Dermopharmaceutic and Cosmetic Applications: Development, Stability, Safety, and In Vitro B - PMID 37836750 (2023, Molecules): Cannabidiol-Loaded Lipid-Stabilized Nanoparticles Alleviate Psoriasis Severity in Mice: A New Approach for Improved Topi

근거 동료심사 학술 논문 (미국 NIH PubMed) (12)

Clinical Evaluation of a Soap-Free Cleansing Lotion Containing Sodium Cocoyl Apple Amino Acids for Effective Impurity Removal and Skin Barrier Preservation in Healthy Adults With Diverse Skin Types [PMID: 40978887 · 2025]
Patel M, Khatri A, Khatri R, Sreevallabhan S, Jose S, Patel N, Merja A · Cureus (2025)

Effective facial cleansing is essential for removing dirt, oil, and impurities without compromising the skin barrier and hydration.&#xa0;However, many conventional cleansers contain harsh surfactants that may strip the skin of its natural lipids, leading to dryness, irritation, and barrier disruption. This study aimed to assess the safety and efficacy of a cleansing lotion containing cetyl alcohol and sodium cocoyl apple amino acids in eliminating skin surface impurities while preserving skin barrier function in healthy adult subjects with diverse skin types, including dry, oily, sensitive, combination, and normal. This open-label, interventional study enrolled 27 participants, all of whom completed the 30-day study. The product's effectiveness was assessed through key clinical and instrumental evaluations, focusing on skin surface impurities by assessing porphyrin levels (size, value, and quantity)&#xa0;and skin tone, along with hydration, barrier function, and overall dry skin score. After 30 days of use, significant improvements were observed across all parameters. Skin surface impurities reduced, as evidenced by porphyrin size, quantity, and values reduced to 0.29 &#xb1; 0.23, 7.11 &#xb1; 4.96, and 130.30 &#xb1; 16.28, respectively. Overall skin tone improved to 22.78 &#xb1; 14.58, skin hydration improved to 46.07 &#xb1; 8.47, and barrier function improved to 9.27 &#xb1; 1.83, with all changes being statistically significant (p &lt; 0.0001). No adverse event was reported during the conduct of the study. The soap-free cleansing lotion demonstrated clinical efficacy and excellent tolerability, effectively removing skin impurities while maintaining and enhancing skin hydration and maintaining the skin barrier function&#xa0;and overall skin appearance without causing irritation. These findings support its potential as a safe, evidence-based dermatological care, reinforcing its primary claims of effective cleansing and promoting visibly fresher and healthier skin.

Propolis-Loaded Niosomes for Dermopharmaceutic and Cosmetic Applications: Development, Stability, Safety, and In Vitro Bioactivity Studies [PMID: 40672672 · 2025]
Pinto MB, Pires PC, Correia M, Mo&#xe7;o G, Sousa-Oliveira I, Sousa MJ, Calhelha RC, Vilas-Boas M, Falc&#xe3;o S, Gava Mazzola P, Veiga F, Paiva-Santos AC · ACS Pharmacol Transl Sci (2025)

Propolis, produced bybees, is composed of several biologically relevant phenolic compounds with known analgesic, anti-inflammatory, antitumor, antioxidant, immunomodulatory, wound healing, and antibacterial effects, having gained significant interest for therapeutic and cosmetic purposes. Niosomes, self-assembled vesicular nanosystems, are highly researched for topical delivery due to providing controlled and sustained release, protecting encapsulated compounds from degradation, improving stability, and having good biocompatibility and biodegradability. This work aimed to develop novel propolis-loaded niosomes with small and homogeneous particle size, high encapsulation efficiency, controlled release, adequate stability, relevant bioactivity, and high safety for topical application, for therapeutic and/or cosmetic purposes. Aided by quality by design (QbD) analysis, niosomes containing Tween 20, Kolliphor RH 40, cetyl alcohol, and/or cholesterol were produced by thin-film hydration followed by extrusion, with small particle size (between 100 and 200 nm), homogeneous distribution (PDI below 0.2), relevant &#x3b6;-potential (around -38 mV), good stability both under refrigeration and at room temperature, high encapsulation efficiency (ranging from 78.8 to 87.4%), and a controlled release profile, relevant to ensure prolonged bioactivity at the application site. Adequate concentration-dependent in vitro safety in keratinocytes and fibroblasts (up to 12.5 or 25 &#x3bc;g/mL) was demonstrated as well, with some niosomal formulations also showing a low irritative potential in a HET-CAM test, and relevant in vitro anti-inflammatory potential (IC 50 from 14.90 to 17.89 ng/mL). These novel nanoplatforms, containing a nature-derived hydrophobic compound with various relevant bioactivities, could serve as versatile and advantageous formulations in both pharmaceutical and cosmetic contexts of application.

Cannabidiol-Loaded Lipid-Stabilized Nanoparticles Alleviate Psoriasis Severity in Mice: A New Approach for Improved Topical Drug Delivery [PMID: 37836750 · 2023]
Zamansky M, Yariv D, Feinshtein V, Ben-Shabat S, Sintov AC · Molecules (2023)

Cannabidiol (CBD) is a promising natural agent for treating psoriasis. CBD activity is attributed to inhibition of NF-kB, IL-1&#x3b2;, IL-6, and IL-17A. The present study evaluated the anti-psoriatic effect of cannabidiol in lipid-stabilized nanoparticles (LSNs) using an imiquimod (IMQ)-induced psoriasis model in mice. CBD-loaded LSNs were stabilized with three types of lipids, Cetyl alcohol (CA), Lauric acid (LA), and stearic-lauric acids (SALA), and were examined in-vitro using rat skin and in-vivo using the IMQ-model. LSNs loaded with coumarin-6 showed a localized penetration depth of about 100 &#xb5;m into rat skin. The LSNs were assessed by the IMQ model accompanied by visual (psoriasis area severity index; PASI), histological, and pro-psoriatic IL-17A evaluations. Groups treated with CBD-loaded LSNs were compared to groups treated with CBD-containing emulsion, unloaded LSNs, and clobetasol propionate, and to an untreated group. CBD-loaded LSNs significantly reduced PASI scoring compared to the CBD emulsion, the unloaded LSNs, and the untreated group (negative controls). In addition, SALA- and CA-containing nanoparticles significantly inhibited IL-17A release, showing a differential response: SALA &gt; CA &gt; LA. The data confirms the effectiveness of CBD in psoriasis therapy and underscores LSNs as a promising platform for delivering CBD to the skin.

A Sucrose Fatty Acid Ester-mixed Emulsifier as Stabilizer of Emulsion Systems [PMID: 37164691 · 2023]
Zhou J, He X, Hu Q · J Oleo Sci (2023)

In the present study, the mesomorphic phase and internal structure of sucrose fatty acid ester (S1670) with cetyl alcohol mixed in different proportions was studied and assessed, within common emulsion system of cosmetics and pharmaceuticals. To characterize the system's colloidal structure the following physicochemical techniques were used: polarization microscopy, small- and wide-angle X-ray scattering (SAXS and WAXS), differential scanning calorimetry (DSC), continual and oscillatory rheology and cryogenic scanning electron microscopy (cryo-SEM). Ultimately, it was well established that there was a predominant and stable &#x3b1;-crystalline gel structure, formed with sucrose fatty acid ester (S1670) and cetyl alcohol, in the pseudo quarter-phase system (including squalane and aqua). In addition, the optimum ratio for &#x3b1;-crystalline gel formation was found to be around 61.50:38.50 (S1670 to Cetyl alcohol). Moreover, as it deviates from the critical point within a controllable range, although identical &#x3b1;-gel (&#x3b1;-form hydrated crystal) continues to exist, yet the strength and proportion in whole sample decrease with the expansion of deviation. The decent stability (which was derived from the dismatch between the lipophilic chains and the intensive hydration of -OH from S1670) and the agreeable rheological properties of the above &#x3b1;-gel suggest wide application in cosmetics and pharmacy in the future.

Development and quality assessment of glutathione tripeptide loaded niosome containing carbopol emulgels as nanocosmeceutical formulations [PMID: 37119885 · 2023]
Inal O, Amasya G, Sezgin Bayindir Z, Yuksel N · Int J Biol Macromol (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&#xae; 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&#xae;, 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.

The Fundamental Role of Lipids in Polymeric Nanoparticles: Dermal Delivery and Anti-Inflammatory Activity of Cannabidiol [PMID: 36838759 · 2023]
Zamansky M, Zehavi N, Sintov AC, Ben-Shabat S · Molecules (2023)

This report presents a nanoparticulate platform for cannabidiol (CBD) for topical treatment of inflammatory conditions. We have previously shown that stabilizing lipids improve the encapsulation of CBD in ethyl cellulose nanoparticles. In this study, we examined CBD release, skin permeation, and the capability of lipid-stabilized nanoparticles (LSNs) to suppress the release of IL-6 and IL-8. The nanoparticles were stabilized with cetyl alcohol (CA), stearic acid (SA), lauric acid (LA), and an SA/LA eutectic combination (SALA). LSN size and concentration were measured and characterized by differential scanning calorimetry (DSC), in vitro release of loaded CBD, and skin permeability. IL-6 and IL-8 secretions from TNF-&#x3b1;-induced HaCaT cells were monitored following different LSN treatments. CBD released from the LSNs in dispersion at increasing concentrations of polysorbate 80 showed non-linear solubilization, which was explained by recurrent precipitation. A significant high release of CBD in a cell culture medium was shown from SALA-stabilized nanoparticles. Skin permeation was &gt;30% lower from SA-stabilized nanoparticles compared to the other LSNs. Investigation of the CBD-loaded LSNs' effect on the release of IL-6 and IL-8 from TNF-&#x3b1;-induced HaCaT cells showed that nanoparticles stabilized with CA, LA, or SALA were similarly effective in suppressing cytokine release. The applicability of the CBD-loaded LSNs to treat topical inflammatory conditions has been supported by their dermal permeation and release inhibition of pro-inflammatory cytokines.

Formulation of the Polysaccharide FucoPol into Novel Emulsified Creams with Improved Physicochemical Properties [PMID: 36431860 · 2022]
Baptista S, Freitas F · Molecules (2022)

Driven by the customers' growing awareness of environmental issues, the production of topical formulations based on sustainable ingredients is receiving widespread attention from researchers and the industry. Although numerous sustainable ingredients (natural, organic, or green chemistry-derived compounds) have been investigated, there is a lack of comparative studies between conventional ingredients and sustainable alternatives. In this study, olive oil (30 wt.%) and &#x3b1;-tocopherol (2.5 wt.%) containing oil-in-water (O/W) emulsions stabilized with the bacterial fucose-rich polysaccharide FucoPol were formulated envisaging their validation as cosmetic creams. After formula composition design by Response Surface Methodology (RSM), the optimized FucoPol-based emulsion was prepared with 1.5 wt.% FucoPol, 1.5 wt.% cetyl alcohol, and 3.0 wt.% glycerin. The resulting emulsions had an apparent viscosity of 8.72 Pa.s (measured at a shear rate 2.3 s -1 ) and droplet size and zeta potential values of 6.12 &#xb5;m and -97.9 mV, respectively, which are within the values reported for cosmetic emulsified formulations. The optimized formulation displayed the desired criterium of a thin emulsion system, possessing the physicochemical properties and the stability comparable to those of commercially available products used in cosmeceutical applications.

Natural Is Not Always Better: The Prevalence of Allergenic Ingredients in "Clean" Beauty Products [PMID: 35256558 · 2022]
Tran JM, Comstock JR, Reeder MJ · Dermatitis (2022)

Consumers seek "clean" and "natural" products based on their perception of safety. However, there is no standard, scientific basis, or regulatory oversight in the marketing or ingredient use for "clean" products. The aim of this study was to determine the prevalence of allergenic ingredients in "clean" products. Target and Walgreens Web sites were queried for "clean" products with inclusion of 1470 products. Ingredient lists were analyzed for potential allergens. Analysis included descriptive statistics and &#x3c7;2 test. The most common allergens were fragrances/botanicals (1218/1470, 82.9%), phenoxyethanol (591/1470, 40.2%), tocopherol (545/1470, 40.2%), benzoic acid and benzoates (434/1470, 29.5%), propylene glycol (369/1470, 25.1%), alkyl glucosides (305/1470, 20.7%), ethylhexylglycerin (304/1470, 20.7%), cetyl alcohol (282/1470, 19.2%), cocamidopropyl betaine (258/1470, 17.6%), and benzyl alcohol (232/1470, 15.8%). Among fragrances/botanicals, the most common ingredients found were fragrance/perfume/aroma (911/1470, 68.2%), citrus derivatives (375/1470, 25.5%), linalool (305/1470, 20.7%), limonene (279/1470, 19.0%), and benzyl alcohol (231/1470, 15.7%). A total of 93.8% of the products (1379/1470) contained at least 1 potential allergen. Most "clean" products contain a potential allergen, predominately fragrances and botanicals.

Seven cases of contact dermatitis due to stearyl alcohol contained in topical medications [PMID: 35174533 · 2022]
Nishioka K, Koizumi A, Takita Y · J Dermatol (2022)

Stearyl alcohol is found in various cosmetics and topical medications and is regarded as safe. Allergic contact dermatitis is reported due to this chemical on rare occasions. We report seven cases, comprising three men and four women aged between 36 and 62 between the years 2013 to 2019, of allergic contact dermatitis due to the use of topical medication, where the patient showed a positive result to a patch test using stearyl alcohol. There were 10 topical medications that we considered to be the cause of this: three were from Oronine &#xae; H ointment, two from Eurax &#xae; cream, one from Eurax H cream, and four from topical antifungal medications. All these medications contained stearyl alcohol. Seven cases of patch tests with stearyl alcohol all showed positive results. Moreover, having done a patch test with cetyl alcohol, two out of three tests showed positive. When researching allergic contact dermatitis due to topical medications, it is important to test for allergy to stearyl alcohol as well as their main ingredients, because it is contained in numerous products and has the ability to cause allergic contact dermatitis.

Investigating the influence of excipient batch variation on the structure, consistency and physical stability of polysorbate 60-based topical vehicles [PMID: 34714546 · 2021]
Vu Dang H, Tran Huu H, Nguyen HMT · Int J Cosmet Sci (2021)

Fatty alcohol-polysorbate 60-water ternary systems were used as models to represent the continuous phases of the respective semisolid oil-in-water emulsions for topical delivery of cosmetic and medicinal agents. The influence of batch variation of polysorbate 60 and fatty alcohol on structure and consistency of these systems was investigated using microscopy, rheology, differential scanning calorimetry and X-ray scattering techniques. The polysorbate 60 : cetostearyl alcohol mixed emulsifying wax showed swelling in water, that is, the lamellar repeat distance continually augmented from 93 to 125&#xa0;&#xc5; with water percentage 20-90%. Cetostearyl alcohol ternary systems were thicker than cetyl alcohol ones independently of polysorbate 60 batches used. All the ternary systems showed an initial increase in consistency over the first 2&#xa0;weeks of storage, which was followed by slight changes in consistency (cetostearyl alcohol systems) due to the re-allocation of polysorbate 60 molecules in the gel network or significant breakdown of structure (cetyl alcohol systems) due to the transformation of swollen &#x3b1;-lamellar gel phase into &#x3b2;, &#x3b3; crystals on 25&#xb0;C storage. With all fatty alcohols, the consistency of polysorbate 60 ternary system was directly dependent upon interlamellar water thickness as governed by the length and distribution of polyoxyethylene groups within polysorbate 60&#xa0;molecules. In relation with the composition of polysorbate 60 batches used, the consistency of ternary systems was higher when prepared with the polysorbate 60 batch containing a greater amount of sorbitan polyoxyethylene monoesters. It was proposed that the swollen &#x3b1;-crystalline gel phase could be better formed by sorbitan polyoxyethylene monoesters rather than sorbitan polyoxyethylene diesters. Des systemes ternaires alcool gras-polysorbate 60-eau ont &#xe9;t&#xe9; utilis&#xe9;s comme mod&#xe8;les pour repr&#xe9;senter les phases continues des &#xe9;mulsions huile-dans-eau semi-solides respectives pour l'administration topique d'agents cosm&#xe9;tiques et m&#xe9;dicinaux. L'influence de la variation des lots de polysorbate 60 et d'alcool gras sur la structure et la consistance de ces syst&#xe8;mes a &#xe9;t&#xe9; &#xe9;tudi&#xe9;e en utilisant la microscopie, la rh&#xe9;ologie et la calorim&#xe9;trie diff&#xe9;rentielle &#xe0; balayage et la diffusion des rayons X. La cire &#xe9;mulsifiante mixte polysorbate 60 : alcool c&#xe9;tostearylique a montr&#xe9; un gonflement dans l'eau, c'est-&#xe0;-dire que la distance de r&#xe9;p&#xe9;tition du motif lamellaire a continuellement augment&#xe9;e de 93 &#xe0; 125 A&#xb0; avec un pourcentage d'eau de 20-90%. Les syst&#xe8;mes ternaires d'alcool c&#xe9;tostearylique &#xe9;taient plus &#xe9;pais que ceux d'alcool c&#xe9;tylique ind&#xe9;pendamment des lots de polysorbate 60 utilis&#xe9;s. Tous les syst&#xe8;mes ternaires ont montr&#xe9; une augmentation initiale de la consistance au cours des 2 premi&#xe8;res semaines de stockage, qui a &#xe9;t&#xe9; suivie par de l&#xe9;gers changements de consistance (syst&#xe8;mes d'alcool c&#xe9;tostearylique) en raison de la re-affectation des mol&#xe9;cules de polysorbate 60 dans le r&#xe9;seau de gel ou d&#x2019;une rupture significative de structure (syst&#xe8;mes d'alcool c&#xe9;tylique) en raison de la transformation des phases lamellaires gonfles de type &#x3b1;-gel en cristaux &#x3b2;, &#x3b3; conserv&#xe9;s a 25&#xb0;C. Avec tous les alcools gras, la consistance du syst&#xe8;me ternaire polysorbate 60 d&#xe9;pendait directement de l'&#xe9;paisseur inter lamellaire de l'eau car gouvern&#xe9; par la longueur et la distribution des groupes de polyoxyethyl&#xe8;ne au sein des mol&#xe9;cules de polysorbate 60. En relation avec la composition des lots de polysorbate 60 utilis&#xe9;s, la consistance des syst&#xe8;mes ternaires &#xe9;tait plus &#xe9;lev&#xe9;e lorsque pr&#xe9;par&#xe9; avec le lot de polysorbate 60 contenant une plus gran

Development of solid lipid microparticles (SLMs) containing asiatic acid for topical treatment of acne: Characterization, stability, in vitro and in vivo anti-acne assessment [PMID: 38460769 · 2024]
Chutoprapat R, Witarat J, Jongpanyangarm P, Mang Sung Thluai L, Khankaew P, Wah Chan L · Int J Pharm (2024)

Solid lipid microparticles (SLMs) represent a promising approach for drug delivery in anti-acne applications. In this study, asiatic acid-loaded SLMs (AASLMs) were prepared by melt emulsification method in conjunction with freeze-drying. Comprehensive evaluations comprised particle size, %entrapment efficiency (%EE), %labeled amount (%LA), surface morphology, stability, %release, %skin permeation, and anti-acne activity. The AASLMs exhibited an average particle size ranging from 7.46 to 38.86&#xa0;&#xb5;m, with %EE and %LA falling within the range of 31.56 to 100.00 and 90.43 to 95.38, respectively. The AASLMs demonstrated a spherical shape under scanning electron microscopy, and maintained stability over a 3-month period. Notably, formulations with 10&#xa0;% and 15&#xa0;% cetyl alcohol stabilized with poloxamer-188 (specifically F6 and F12) displayed a minimum inhibitory concentration (MIC) value of 75&#xa0;mg/ml against Cutibacterium acnes. Furthermore, F12 exhibited a higher %release and %skin permeation compared to F6 over 24&#xa0;h. In a single-blind clinical trial involving fifteen participants with mild-to-moderate acne, F12 showcased its potential not only in reducing porphyrin intensity and enhancing skin barriers but also in significantly improving skin hydration and brightness. However, further investigations with larger subject cohorts encompassing diverse age groups and genders are necessary to thoroughly establish the performance of the developed AASLMs.

Formulation, characterization of Quercus infectoria (Olivier) emulsions, and in vitro, in vivo evaluation as cosmeceutical formulation [PMID: 37335816 · 2023]
Choudhry A, Akhtar N · J Cosmet Dermatol (2023)

Pharmacological properties of Quercus infectoria Olivier (galls) have been determined to be astringent, antidiabetic, antipyretic, anti-tremor, local anesthetic, and anti-parkinsonism. The galls of Quercus infectoria have been used for millennia in traditional oriental medicine in Asian nations to treat inflammatory illnesses. The study's objective was to create a Quercus infectoria Olivier gall extract in stable water in oil (w/o) emulsion and to check its effects on the mechanical properties of skin and antiaging effects. The galls were macerated in absolute methanol. Quercus infectoria Olivier gall extract's antioxidant property was evaluated using the 2, 2-diphenyl-1-picrylhydrazyl (DPPH) technique. Stearic acid, cetyl alcohol, KOH, glycerin, and distilled water were used to create the emulsion. The test (with extract) and control (without extract) emulsions were made, respectively, using the same process. Stability tests (color, liquefaction, microscopy, phase separation, and pH) are performed in in vitro, lasted 72&#x2009;days at four distinct storage temperatures that is 8&#xb0;C, 25&#xb0;C, 40&#xb0;C, and 40&#xb0;C + 75% RH for both the control and test formulations. By using spectrophotometry, the (SPF) sun protection factors of the two formulations were calculated at various concentrations. Extract from Quercus infectoria underwent phytochemical investigation as well. The results showed that Quercus infectoria Olivier has antioxidant and (SPF) sun protection properties, reduce sebum, increases elasticity and stable emulsion containing 04% Quercus infectoria gall extract which might be used as topical antiaging formulation.

자주 묻는 질문 (AEO 스니펫 최적화 FAQ)

Q1. 세틸알코올 (CETYL ALCOHOL)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
한국 식약처 표준명은 '세틸알코올', 미국 PCPC 및 유럽 CosIng INCI 표기는 'CETYL ALCOHOL', 중국 NMPA IECIC 표준명은 '鲸蜡醇', 일본 화장품 표시명칭은 'セタノール'입니다.
Q2. 세틸알코올의 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 세틸알코올의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
대표 제형군(aqueous_serum) 기준 통상 0.2~2%(권장 중앙값 1%) 범위로 투입하며, 적정 pH는 4~8입니다.
Q4. 세틸알코올 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
주요 권장 시너지 조합은 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL이며, 배합 주의사항은 처방 내 극단적 pH 조건 및 고농도 전해질과의 상용성 사전 확인 권장입니다.