# DMDM HYDANTOIN (dmdm-hydantoin) — Global Cosmetic Regulatory & Formulation Monograph - **Canonical URL**: https://www.inciname.com/en/ingredients/dmdm-hydantoin - **Standard INCI**: `DMDM HYDANTOIN` - **KR MFDS Standard Name**: `디엠디엠하이단토인` - **CAS No.**: `6440-58-0` - **EC / EINECS No.**: `229-222-8` - **Origin**: `synthetic` - **Functions**: 방부제 - **Molecular Formula / MW**: `—` (— g/mol) ## 1. 7-Track Official Regulatory Label Names | Track | Official Label Nomenclature | | :--- | :--- | | KR (MFDS Standard) | 디엠디엠하이단토인 | | KR (Former Names) | — | | EU (CosIng 1223/2009) | DMDM HYDANTOIN | | US (PCPC / MoCRA INCI) | DMDM HYDANTOIN | | US (FDA OTC Monograph) | — | | CN (NMPA IECIC) | DMDM 乙内酰脲 | | JP (JCIA / MHLW QD) | DMDM HYDANTOIN | ## 2. Layer 1 — Global 6-Region Statutory Summary - **KR (MFDS)**: `restricted` - **EU (1223/2009)**: `restricted` - **US (FDA/MoCRA)**: `none` - **CN (NMPA IECIC)**: `restricted` (Entry: `379`) - **JP (MHLW)**: `none` - **ASEAN (ACD)**: `none` ## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations - Listed within general cosmetic GMP safety thresholds. ## 4. Layer 3 — Formulation Quartiles & Compatibility - **Optimal pH Window**: 4 – 8 - **Max Process Temp**: ≤ 50°C - **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL - **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads ## 5. Academic Monograph ■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: DMDM HYDANTOIN | CAS No.: 6440-58-0 | EC No.: 229-222-8 - Origin: SYNTHETIC | Functions: - Physicochemical Profile: Formula | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [DMDM HYDANTOIN] · EU [DMDM HYDANTOIN] · CN [DMDM 乙内酰脲] · JP [-] · JP Quasi-Drug [-] ■ [2. Dermatological Mechanism of Action & Functional Role] - DMDM Hydantoin is the organic compound that conforms to the formula: 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: RESTRICTED | EU: RESTRICTED | US: NONE | CN: RESTRICTED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 379 (DMDM 乙内酰脲)) - [KR / COMPOSITION / limited] (Max 0.6%): - [CN / COMPOSITION / limited] (Max 0.6%): - [EU / COMPOSITION / limited] (Max 0.6%): - Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [cleanser_rinse] Typical range: 0.4 ~ 0.4% (Median 0.4%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, ELEMENTIS 6)) — Rinse-off cleanser & surfactant system 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: DMDM HYDANTOIN ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 36981689 (2023, Int J Environ Res Public Health): Potential Carcinogens in Makeup Cosmetics. - PMID 30145645 (2019, Clin Rev Allergy Immunol): Contact Dermatitis to Medications and Skin Products. - PMID 32492262 (2021, J Cosmet Dermatol): Skin irritation potential of cosmetic preservatives: An exposure-relevant study. ## 6. Linked PubMed Literature - [PMID: 36981689] Potential Carcinogens in Makeup Cosmetics. — *Int J Environ Res Public Health* (2023) - [PMID: 30145645] Contact Dermatitis to Medications and Skin Products. — *Clin Rev Allergy Immunol* (2019) - [PMID: 32492262] Skin irritation potential of cosmetic preservatives: An exposure-relevant study. — *J Cosmet Dermatol* (2021) - [PMID: 30971499] Topical therapeutic corneal and scleral tissue cross-linking solutions: in vitro formaldehyde release studies using cosmetic preservatives. — *Biosci Rep* (2019) - [PMID: 37177794] Quantitative Risk Assessment of Dermal Sensitization Potential Following Use of Shampoo Products Containing the Formaldehyde Releasing Preservative DMDM Hydantoin. — *Int J Toxicol* (2023) - [PMID: 42035787] The Prevalence of Contact Allergy to Formaldehyde and Formaldehyde Releasers: A Systematic Review and Meta-Analysis — *Contact Dermatitis* (2026) - [PMID: 41679733] Marked Impact of Regulatory Bans on Formaldehyde and Formaldehyde-Releaser-Induced Allergic Contact Dermatitis: A Retrospective Cohort Study (1996-2024) From Turkey — *Contact Dermatitis* (2026) - [PMID: 41267567] A Cross-Sectional Study of Contact Allergens in Hotel Personal Care Products in Canada, the United States and Europe — *Contact Dermatitis* (2026) - [PMID: 37429522] From worst-case to reality - Case studies illustrating tiered refinement of consumer exposure to cosmetic ingredients — *Regul Toxicol Pharmacol* (2023) - [PMID: 35229319] Contact allergy to and allergic contact dermatitis from formaldehyde and formaldehyde releasers: A clinical review and update — *Contact Dermatitis* (2022) - [PMID: 33577887] In vitro skin penetration of bronidox, bronopol and formaldehyde from cosmetics — *Regul Toxicol Pharmacol* (2021) - [PMID: 32876992] Formaldehyde 2% is not a useful means of detecting allergy to formaldehyde releasers- results of the ESSCA network, 2015-2018 — *Contact Dermatitis* (2021) - [PMID: 38972480] Cost-effectiveness of patch testing allergens within the same group: A computational approach to optimize formaldehyde-related allergen selection — *J Am Acad Dermatol* (2024)