原料词典检索/cetyl-alcohol/CETYL ALCOHOL
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
化学合成 (Synthetic)

CETYL ALCOHOL

中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名: 鲸蜡醇 (序号 #3526)
香精 / 香料遮光剂柔润剂乳化剂乳化稳定剂发泡促进剂清洁剂粘度调节剂
核心法规与安全结论 (Executive Fact Box)AEO / GEO CITATION ANCHOR

化妆品中 鲸蜡醇 (CETYL ALCOHOL) 的全球法规限值与配方应用标准是什么?

鲸蜡醇(标准 INCI: CETYL ALCOHOL,CAS 号: 36653-82-4)是化妆品配方中主要用作香精 / 香料, 遮光剂, 柔润剂的核心成分。受中国 NMPA(已使用/准用)、韩国 MFDS(未列管)及欧盟 CosIng(未列管)等 6 大法域法定标准监管,常规建议添加量为 0.2–2%(最佳稳定窗口 pH 4–8)。

全球 7 轨官方全成分标签名称对照表

严格采用各国政府官方目录原名 · 严禁机器翻译
7-Track Official Statutory Label Names for CETYL ALCOHOL
法域与监管轨道官方公告全成分标准名称一键复制
① 韩国 (MFDS 化妆品标准名称)CETYL ALCOHOL (KR MFDS Registered)
② 韩国旧名称历史 (301 重定向)——
③ 欧盟 (EU CosIng EC 1223/2009)CETYL ALCOHOL
④ 美国普通化妆品 (US PCPC / MoCRA INCI)CETYL ALCOHOL
⑤ 美国 OTC 防晒/祛痘专论活性物名称 (FDA OTC)— (非美国 OTC 专论活性成分 / 普通化妆品原料)—
⑥ 中国 (NMPA《已使用化妆品原料目录 IECIC》标准中文名)鲸蜡醇
⑦ 日本普通化妆品 / 医药部外品 (JCIA / MHLW)セタノール · [QD: セタノール]

Layer 1 — 全球 6 大法域法定限值与监管状态

Layer 1 Statutory Regulatory Limits Across 6 Regions for CETYL ALCOHOL
法域监管状态法定限值适用条件与法定依据来源
韩国 (MFDS)未列管GMP已列入官方化妆品原料目录 (按 GMP 规范使用)
欧盟 (EU)未列管GMP已列入官方化妆品原料目录 (按 GMP 规范使用)
美国 (FDA)未列管GMP已列入官方化妆品原料目录 (按 GMP 规范使用)
中国 (NMPA)已使用/准用GMPIECIC Entry #3526
日本 (MHLW)未列管GMP已列入官方化妆品原料目录 (按 GMP 规范使用)
东盟 (ACD)未列管GMP已列入官方化妆品原料目录 (按 GMP 规范使用)

Layer 2 — 毒理评估与历史最高使用量 (CN IECIC / US CIR / EU SCCS)

“欧盟 SCCS 安全评估上限”代表消费者安全科学委员会判定安全边际 (MoS≥100) 的毒理阈值;“美国 CIR 市售最高报告浓度”与“中国 IECIC 最高历史使用量”代表已上市化妆品的最高实际使用浓度。

Layer 2 Toxicological & Historical Safe Use Concentrations for CETYL ALCOHOL
安全评估依据适用范围与剂型评估浓度范围评估结论与文献档案
中国 IECIC 最高历史使用量leave_on≤ 15%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 03495 (2025)
中国 IECIC 最高历史使用量rinse_off≤ 10%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 03495 (2025)
⚠️ 仅供参考 (免责声明): 本词典中的原料名称、法规限值与配比指南仅供研发参考。鉴于法规修订时差或潜在数据误差,实际配方设计、标签印制及备案前请务必核实主管部门最新官方公告原文;因使用本词典信息产生的任何问题,运营方概不承担法律责任。
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)

Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit

Aqueous Serum / Ampoulen=7
Min 0.2% · Q1 0.75% · Median 1% · Q3 1.5% · Max 2%
Emulsion / Creamn=14
Min 0.5% · Q1 0.6% · Median 0.6% · Q3 0.9375% · Max 1.2%
Sunscreen / Colorn=8
Min 0.55% · Q1 1% · Median 1% · Q3 1.25% · Max 3%
Aqueous Serum / Ampoule — Aqueous serum, toner & hydrogel matrix formulation component
Verified Source: Global Starter Formulation Library Statistical Distribution (n=7, GRANT 7) (cir_safety) · GRANT 7
Typical Median: 1%

Layer 3 — 剂型常规配比指南与理化配伍性

Layer 3 Formulation Concentration Quartiles by Product Category for CETYL ALCOHOL
剂型分类Min – Q1 – Median – Q3 – Max (%)配方作用与机理Source ID
剂型组 A — 水剂爽肤水 / 精华液 / 安瓶0.2% · 0.75% · 1% · 1.5% · 2%Aqueous serum, toner & hydrogel matrix formulation componentGlobal Starter Formulation Library Statistical Distribution (n=7, GRANT 7)
剂型组 B — 乳液 / 面霜 (O/W · W/O)0.5% · 0.6% · 0.6% · 0.9375% · 1.2%Emulsion cream & lotion structural / conditioning agentGlobal Starter Formulation Library Statistical Distribution (n=14, GRANT 13 · SEPPIC 1)
剂型组 D — 防晒霜 / 彩妆 / 粉底0.55% · 1% · 1% · 1.25% · 3%Sun care & color cosmetics dispersion / sensory modifierGlobal Starter Formulation Library Statistical Distribution (n=8, GRANT 6 · ELEMENTIS 1 · SEPPIC 1)
Cutaneous Permeation Science (500 Dalton Rule)MW: Macro/Complex · LogP: N/A

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (320 Da ≤ 500 Da) — Passive Permeation Feasible

Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.

Estimated Target Depth
40–90 µm
Optimal Delivery System
Polyol Enhancer / Serum
Colloid Interface, pH Spectrum & Thermal Stability

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Water or glycol phase soluble/dispersible
Optimal Formulation pH Stability Window (0–14)pH 4.0 – 8.0
0245.5791114

Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 50°C
25°C45°C60°C75°C85°C100°C

Thermally stable up to 50°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
Biochemical Signaling & Mechanism Pathway

Cellular & Molecular Target Mechanism Flow

1. Epidermal Interaction→ Upregulation / Activation
Intercellular Lipid & Hydration Matrix
→
TEWL Reduction & Barrier Conditioning
2. Homeostasis Modulation⊣ Inhibition / Blockade
Oxidative Stress (ROS) & Irritant Cascade
⊣
Cutaneous Soothing & Homeostasis
Formulation Ontology Radial Graph

Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)

+ GLYCERIN+ CAPRYLIC/CAPRIC TR…+ TOCOPHEROL✕ Verify phase compati…CETYL ALCOHOL
Interactive Node Guide

Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.

代表性商品名参考 (商标法第90条第1款第2项说明性标示)
CETYL ALCOHOL

商品名仅供配方师识别原料规格参考,商标权归各原厂商所有。

学术与毒理综合摘要

Tier 1 Synthesis

本综述严格基于与该原料关联的 NIH PubMed 同行评审文献摘要及官方毒理学评估档案编写。

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: CETYL ALCOHOL | CAS No.: 36653-82-4 | EC No.: 253-149-0 - Origin: SYNTHETIC | Functions: , , , , , , , - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [CETYL ALCOHOL] · EU [CETYL ALCOHOL] · CN [鲸蜡醇] · JP [セタノール] · JP Quasi-Drug [セタノール] ■ [2. Dermatological Mechanism of Action & Functional Role] - CETYL ALCOHOL functions primarily as , , , , , , , in dermatological and cosmetic formulations. Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver , , , , , , , performance and structural formulation stability. ■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)] - Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 3526 (鲸蜡醇)) - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment). - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 15.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 10.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 0.2 ~ 2.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, GRANT 7)) — Aqueous serum, toner & hydrogel matrix formulation component - [emulsion_cream] Typical range: 0.5 ~ 1.2% (Median 0.6%, Ref: Global Starter Formulation Library Statistical Distribution (n=14, GRANT 13 · SEPPIC 1)) — Emulsion cream & lotion structural / conditioning agent - [sun_color] Typical range: 0.55 ~ 3.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=8, GRANT 6 · ELEMENTIS 1 · SEPPIC 1)) — Sun care & color cosmetics dispersion / sensory modifier ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Water Phase or Cool-down Phase (< 45°C) - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: CETYL ALCOHOL ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - 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

关联同行评审文献 (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.

常见问题解答 (FAQ)

Q1. 鲸蜡醇 (CETYL ALCOHOL) 在全球 7 大法域的官方全成分标签名称是什么?
中国 NMPA《已使用化妆品原料目录 (IECIC)》标准中文名为 '鲸蜡醇',美国 PCPC 与欧盟 CosIng 标准 INCI 为 'CETYL ALCOHOL',日本 JCIA 表示名称为 'セタノール'。
Q2. 鲸蜡醇 (CETYL ALCOHOL) 在中、韩、欧、美、日、东盟的法定监管状态 (Layer 1) 如何?
6 大法域监管汇总 — 中国(CN): allowed,韩国(KR): none,欧盟(EU): none,美国(US): none,日本(JP): none,东盟(ASEAN): none。
Q3. 鲸蜡醇 (CETYL ALCOHOL) 的常规配方添加量 (Layer 3) 与最佳稳定 pH 窗口是多少?
在代表性剂型 (aqueous_serum) 中常规添加量为 0.2%–2%(中位数 1%),最佳稳定 pH 范围为 4–8。
Q4. 鲸蜡醇 (CETYL ALCOHOL) 有哪些配伍禁忌 (Incompatibilities) 与协同增效组合?
推荐协同组合包括 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL;配伍禁忌注意:Verify phase compatibility under extreme pH or high electrolyte loads。