# GUAIAZULENE (guaiazulene) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/guaiazulene
- **Standard INCI**: `GUAIAZULENE`
- **KR MFDS Standard Name**: `구아이아줄렌`
- **CAS No.**: `489-84-9`
- **EC / EINECS No.**: `207-701-2`
- **Origin**: `synthetic`
- **Functions**: 항균제, 향료
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 구아이아줄렌 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | GUAIAZULENE |
| US (PCPC / MoCRA INCI) | GUAIAZULENE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 愈创薁 |
| JP (JCIA / MHLW QD) | GUAIAZULENE  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `allowed`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `restricted`
- **CN (NMPA IECIC)**: `allowed` (Entry: `8245`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `restricted`

- **US** [restricted]: — — [US RESTRICTED] * Eye Area : No 
* 눈 주위 : 사용금지 
* Generally  (Includes  Lipsticks) : No 
* 일반적인 사용 (립스틱 포함) : 사용금지 
* External Use : Yes 
* 외용 : 사용가능 (식약처 국가별 사용제한원료정보 API (미국))
- **ASEAN** [restricted]: — — [ASEAN RESTRICTED] * 단서조항(주석) : (3) Adopted during the Fifth ASEAN Cosmetic Committee Meeting 
(3) 제5회 아세안 화장품 위원회에서 채택됨 
* Field of application : Colouring agents allowed in all cosmetic products except those intended to be applied in the vicinity of eyes, in particular eye make-up and eye make-up remover. 
* 적용 범위 : 아이 메이크업이나 아이 메이크업 리무버에 사용되는 것을 제외한 모든 제품에서 허용된 착색제 (식약처 국가별 사용제한원료정보 API (아세안))
- **KR** [allowed]: — —  (화장품의 색소 종류 및 기준 [별표1] 화장품의 색소(제3조 관련))

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 0.2% — NMPA IECIC (2025) Entry 08112 (2025)
- **cn_iecic_max** (rinse_off): ≤ 0.1% — NMPA IECIC (2025) Entry 08112 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4.5 – 7.5
- **Max Process Temp**: ≤ 70°C
- **Synergy Pairings**: —
- **Incompatibilities**: —

## 5. Academic Monograph
Guaiazulene is an FDA-approved bicyclic sesquiterpene commonly used as a cosmetic colorant component.
It possesses autophagy-inducing capacity and functions in an mTOR-independent manner.
It exhibits tumor suppression effects through ROS-induced apoptosis while simultaneously triggering protective autophagy.
Its primary characteristics include antioxidant and anti-inflammatory actions, which may help manage various conditions involving lipid peroxidation and inflammatory responses.
It demonstrates therapeutic potential in managing bacterial infections, tumors, immunomodulation, ulcers, dermatitis, and gastritis.
In the treatment of neurodermatitis, it effectively improves skin symptoms, reduces pain and itching, and shortens treatment onset time.
In combination therapy, it reduces adverse reactions from standard treatment and contributes to improved quality of life.

## 6. Linked PubMed Literature
- [PMID: 36646376] Guaiazulene and related compounds: A review of current perspective on biomedical applications. — *Life Sci* (2023)
- [PMID: 39162834] Efficacy and feasibility analysis of compound fluocinolone acetonide cream combined with guaiazulene in the treatment of neurodermatitis. — *Arch Dermatol Res* (2024)
- [PMID: 33935713] Guaiazulene Triggers ROS-Induced Apoptosis and Protective Autophagy in Non-small Cell Lung Cancer. — *Front Pharmacol* (2021)
- [PMID: 40396033] Avobenzone, Guaiazulene and Tioxolone identified as potent autophagy inducers in a high-throughput image based screen for autophagy flux. — *Autophagy Rep* (2022)