# GLUCONOLACTONE (gluconolactone) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/gluconolactone
- **Standard INCI**: `GLUCONOLACTONE`
- **KR MFDS Standard Name**: `글루코노락톤`
- **CAS No.**: `90-80-2`
- **EC / EINECS No.**: `202-016-5`
- **Origin**: `synthetic`
- **Functions**: 킬레이트제, 피부컨디셔닝제
- **Molecular Formula / MW**: `C6H10O6` (178.14 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 글루코노락톤 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | GLUCONOLACTONE |
| US (PCPC / MoCRA INCI) | GLUCONOLACTONE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 葡糖酸内酯 |
| JP (JCIA / MHLW QD) | GLUCONOLACTONE  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `5123`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 10% — NMPA IECIC (2025) Entry 05082 (2025)
- **cn_iecic_max** (rinse_off): ≤ 6% — NMPA IECIC (2025) Entry 05082 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 3.6 – 4.8
- **Max Process Temp**: ≤ 70°C
- **Synergy Pairings**: LACTOBIONIC ACID, SALICYLIC ACID, ARGININE, SODIUM CITRATE, POLYACRYLATE CROSSPOLYMER-6
- **Incompatibilities**: CRITICAL FORMULATION HAZARD (pH Drift): Slowly hydrolyzes in water from a neutral lactone ring into free Gluconic Acid (pKa 3.86) over days/weeks, causing severe pH drop (down to pH < 3.0) and emulsion/viscosity breakdown! Pre-equilibrate in warm water and buffer with Sodium Citrate / Arginine + use SEPIMAX ZEN

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: GLUCONOLACTONE | CAS No.: 90-80-2 | EC No.: 202-016-5
  - Origin: SYNTHETIC | Functions: , 
  - Physicochemical Profile: Formula C6H10O6 | MW 178.14 g/mol | LogP -1.98 | Ionic Nature: anionic | PubChem CID 7027
  - Official Regional Label Names: US [GLUCONOLACTONE] · EU [GLUCONOLACTONE] · CN [葡糖酸内酯] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Cyclic polyhydroxy acid (PHA) lactone bearing multiple hydroxyl groups upon hydrolysis to gluconic acid. Provides gentle stratum corneum exfoliation without sensory stinging due to larger molecular size, coupled with humectancy, metal-chelating antioxidant activity, and barrier strengthening.
■ [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. 5123 (葡糖酸内酯))
  - 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 10.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 6.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [aqueous_serum] Typical range: 1.0 ~ 10.0% (Median 4.0%, Ref: Jungbunzlauer Gluconolactone TDS & PubMed PHA Clinical Studies) — Non-irritating Polyhydroxy Acid (PHA) gentle exfoliant, humectant & antioxidant chelator
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase (Account for gradual hydrolysis into Gluconic Acid — buffer with Sodium Citrate / Arginine / NaOH)
  - Optimal pH Range: pH 3.6 ~ 4.8 | Max Process Temp: Max 70°C | Electrolyte Tolerance: NONE
  - Incompatibility / Caution: CRITICAL FORMULATION HAZARD (pH Drift): Slowly hydrolyzes in water from a neutral lactone ring into free Gluconic Acid (pKa 3.86) over days/weeks, causing severe pH drop (down to pH < 3.0) and emulsion/viscosity breakdown! Pre-equilibrate in warm water and buffer with Sodium Citrate / Arginine + use SEPIMAX ZEN
  - Synergy Pairings: LACTOBIONIC ACID, SALICYLIC ACID, ARGININE, SODIUM CITRATE, POLYACRYLATE CROSSPOLYMER-6 | Reference Trade Names: Jungbunzlauer Gluconolactone USP/FCC
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 42249663 (2026, Int J Toxicol): Safety Assessment of Glycolactones as Used in Cosmetics
  - PMID 41668671 (2026, Int J Cosmet Sci): The effect of a serum containing acetyl hexapeptide-8, dipeptide diaminobutyroyl benzylamide diacetate and gluconolacton
  - PMID 41215631 (2026, Adv Healthc Mater): Versatile Hyaluronic Acid Hydrogels via pH-Induced Gelation for Multifaceted Cutaneous Wound Healing

## 6. Linked PubMed Literature
- [PMID: 42249663] Safety Assessment of Glycolactones as Used in Cosmetics — *Int J Toxicol* (2026)
- [PMID: 41668671] The effect of a serum containing acetyl hexapeptide-8, dipeptide diaminobutyroyl benzylamide diacetate and gluconolactone on skin biomarkers, wrinkles and skin texture: Ex vivo and clinical studies — *Int J Cosmet Sci* (2026)
- [PMID: 41215631] Versatile Hyaluronic Acid Hydrogels via pH-Induced Gelation for Multifaceted Cutaneous Wound Healing — *Adv Healthc Mater* (2026)
- [PMID: 40525233] Simultaneous determination of sodium hyaluronate and gluconolactone in cosmetic products — *Int J Cosmet Sci* (2025)
- [PMID: 40111222] Comparison of Efficacy and Willingness to a 5% Gluconolactone-Based Topical Serum and Intense Pulsed Light in Mild Erythema of Rosacea: A Paired Control Study — *J Cosmet Dermatol* (2025)
- [PMID: 39999379] Development and Characterization of Biocompatible Chitosan-Aloe Vera Films Functionalized with Gluconolactone and Sorbitol for Advanced Wound Healing Applications — *ACS Appl Mater Interfaces* (2025)
- [PMID: 39970231] Gluconolactone restores immune regulation and alleviates skin inflammation in lupus-prone mice and in patients with cutaneous lupus — *Sci Transl Med* (2025)
- [PMID: 39163280] Bioactivation of Konjac Glucomannan Films by Tannic Acid and Gluconolactone Addition — *ACS Appl Mater Interfaces* (2024)
- [PMID: 37357656] Split-face evaluation: Gluconolactone plus oxybrasion versus gluconolactone plus microneedling. The effects on skin parameters — *Skin Res Technol* (2023)
- [PMID: 39387831] Metabolomic differences between exanthematous drug eruption and infectious mononucleosis — *Skin Res Technol* (2024)
- [PMID: 39217204] Injectable bone cement based on magnesium potassium phosphate and cross-linked alginate hydrogel designed for minimally invasive orthopedic procedures — *Sci Rep* (2024)
- [PMID: 38794349] Formulation of Ascorbic Acid and Betaine-based Therapeutic Deep Eutectic System for Enhanced Transdermal Delivery of Ascorbic Acid — *Pharmaceutics* (2024)