# BISABOLOL (bisabolol) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/bisabolol
- **Standard INCI**: `BISABOLOL`
- **KR MFDS Standard Name**: `비사보롤`
- **CAS No.**: `515-69-5`
- **EC / EINECS No.**: `208-205-9`
- **Origin**: `synthetic`
- **Functions**: 향료, 피부컨디셔닝제, 진정제
- **Molecular Formula / MW**: `C15H26O` (222.37 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 비사보롤 |
| KR (Former Names) | 비사볼올 |
| EU (CosIng 1223/2009) | BISABOLOL |
| US (PCPC / MoCRA INCI) | BISABOLOL |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 红没药醇 |
| JP (JCIA / MHLW QD) | BISABOLOL  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `noted`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `2888`)
- **JP (MHLW)**: `restricted`
- **ASEAN (ACD)**: `none`

- **JP** [limited]: ≤ 1.2% —  (化粧品に配合可能な医薬品の成分について(薬食審査発第0524001号) 별첨 「承認化粧品成分の範囲」)
- **KR** [noted]: ≤ 0.5% —  (기능성화장품 심사에 관한 규정 [별표4] 자료제출이 생략되는 기능성화장품의 종류(제6조제3항 관련))

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 2% — NMPA IECIC (2025) Entry 05618 (2025)
- **cn_iecic_max** (rinse_off): ≤ 1% — NMPA IECIC (2025) Entry 05618 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 3.5 – 9
- **Max Process Temp**: ≤ 75°C
- **Synergy Pairings**: RETINOL, PANTHENOL, CERAMIDE NP, GUAIAZULENE, ZINC OXIDE
- **Incompatibilities**: Oil-soluble; requires pre-solubilization (e.g., 1:4 with Polyglyceryl-10 Laurate) for clear aqueous formulas; ISOMER DISTINCTION: Enantiomerically pure (-)-Alpha-Bisabolol exhibits ~2x anti-inflammatory potency and is the specific isomer recognized for KR MFDS 0.5% brightening claim compared to racemic (±)-Bisabolol

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: BISABOLOL | CAS No.: 515-69-5 | EC No.: 208-205-9
  - Origin: SYNTHETIC | Functions: , , 
  - Physicochemical Profile: Formula C15H26O | MW 222.37 g/mol | LogP 3.79 | Ionic Nature: non-ionic | PubChem CID 10586
  - Official Regional Label Names: US [BISABOLOL] · EU [BISABOLOL] · CN [红没药醇] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Monocyclic sesquiterpene alcohol (including racemic (±)-alpha-bisabolol) that inhibits leukotriene and pro-inflammatory cytokine synthesis to soothe UV erythema and chemical irritation while acting as a mild transdermal penetration enhancer.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: NOTED | EU: NONE | US: NONE | CN: ALLOWED | JP: RESTRICTED | ASEAN: NONE (CN IECIC (2025) Entry No. 2888 (红没药醇))
  - [JP / COMPOSITION / limited] (Max 1.2%): 
  - [KR / CLAIM / noted]: 
  - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 2.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 1.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [emulsion_cream] Typical range: 0.1 ~ 1.0% (Median 0.3%, Ref: Symrise Dragosantol / BASF Bisabolol TDS, MFDS Annex 4 & CIR Assessment) — Sesquiterpene soothing, anti-inflammatory & brightening active (KR MFDS Brightening 0.5%)
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Cool-down Phase (< 60°C) or Oil Phase
  - Optimal pH Range: pH 3.5 ~ 9.0 | Max Process Temp: Max 75°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: Oil-soluble; requires pre-solubilization (e.g., 1:4 with Polyglyceryl-10 Laurate) for clear aqueous formulas
  - Incompatibility / Caution: ISOMER DISTINCTION: Enantiomerically pure (-)-Alpha-Bisabolol exhibits ~2x anti-inflammatory potency and is the specific isomer recognized for KR MFDS 0.5% brightening claim compared to racemic (±)-Bisabolol
  - Synergy Pairings: RETINOL, PANTHENOL, CERAMIDE NP, GUAIAZULENE, ZINC OXIDE | Reference Trade Names: Dragosantol® 100, (-)-Alpha-Bisabolol Natural
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 29025339 (2017, Int J Toxicol): Bisabolol
  - PMID 20137740 (2010, Dermatitis): Bisabolol
  - PMID 35164145 (2022, Molecules): Biotransformation of (-)-α-Bisabolol by Absidia coerulea

## 6. Linked PubMed Literature
- [PMID: 29025339] Bisabolol — *Int J Toxicol* (2017)
- [PMID: 20137740] Bisabolol — *Dermatitis* (2010)
- [PMID: 35164145] Biotransformation of (-)-α-Bisabolol by Absidia coerulea — *Molecules* (2022)
- [PMID: 40974418] Bisabolol as a natural anticancer agent: molecular insights and therapeutic potential in oncology — *Med Oncol* (2025)
- [PMID: 34391805] Production of (-)-α-bisabolol in metabolically engineered Saccharomyces cerevisiae — *J Biotechnol* (2021)
- [PMID: 35405982] Health Benefits, Pharmacological Effects, Molecular Mechanisms, and Therapeutic Potential of α-Bisabolol — *Nutrients* (2022)
- [PMID: 35753438] Pharmacological and biological effects of alpha-bisabolol: An updated review of the molecular mechanisms — *Life Sci* (2022)
- [PMID: 41802486] A multi-target combinatorial therapy of MDBA alleviates atopic dermatitis via synchronized immunosuppression and barrier repair — *Eur J Pharmacol* (2026)
- [PMID: 41364478] Functional Characterization of a Sesquiterpene Synthase Involved in Stereospecific Biosynthesis of β-Bisabolol — *J Agric Food Chem* (2025)
- [PMID: 40089261] Exploring the mechanism of α-Bisabolol in the treatment of psoriasis based on network pharmacology and experimental validation — *Eur J Pharmacol* (2025)
- [PMID: 39892675] Topical delivery performance of Pickering emulsions stabilized by differently charged spirulina protein isolate/Chitosan composite particles — *Int J Pharm* (2025)
- [PMID: 36824492] Engineering Saccharomyces cerevisiae for enhanced (-)-α-bisabolol production — *Synth Syst Biotechnol* (2023)
- [PMID: 41551739] Antibiotic-free high-yield (-)-α-bisabolol production in Serratia marcescens via metabolic engineering and genomic integration of mevalonate pathway genes — *Synth Syst Biotechnol* (2026)
- [PMID: 41977782] Effect of Distillation Time on the Yield and Chemical Composition of Leaf Essential Oil from Abies koreana — *Plants (Basel)* (2026)
- [PMID: 41614884] Dermofunctional Vehicle Downregulates LL-37 and MMPs and Upregulates IGFBP-3 — *Curr Issues Mol Biol* (2025)
- [PMID: 40624268] Construction of yeast two-hybrid cDNA library and identification of interacting protein with McHDRa/b in Matricaria chamomilla L — *Plant Mol Biol* (2025)
- [PMID: 40613435] Evaluation of the Efficacy and Safety of a Panthenol-Enriched Mask for Skin Barrier Recovery After Facial Laser Treatment: Results of a Double-Blind Randomized Controlled Study — *J Cosmet Dermatol* (2025)
- [PMID: 40536111] Benefits of a Multifunctional Sunscreen Formulation Containing Nanoencapsulated Antioxidants in the Skin Protection Against UV Radiation and Blue Light: Clinical and Preclinical Studies — *J Cosmet Dermatol* (2025)
- [PMID: 40004021] Enhancing Niacinamide Skin Penetration via Other Skin Brightening Agents: A Molecular Dynamics Simulation Study — *Int J Mol Sci* (2025)
- [PMID: 39741562] The Role of Moisturizer Containing Anti-inflammatory on Skin Hydration in Mild-Moderate Atopic Dermatitis Patients — *Dermatol Res Pract* (2024)