# NIACINAMIDE (niacinamide) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/niacinamide
- **Standard INCI**: `NIACINAMIDE`
- **KR MFDS Standard Name**: `나이아신아마이드`
- **CAS No.**: `98-92-0`
- **EC / EINECS No.**: `202-713-4`
- **Origin**: `vitamin`
- **Functions**: 평활제
- **Molecular Formula / MW**: `C6H6N2O` (122.12 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 나이아신아마이드 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | NIACINAMIDE |
| US (PCPC / MoCRA INCI) | NIACINAMIDE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 烟酰胺 |
| JP (JCIA / MHLW QD) | ナイアシンアミド (QD: ニコチン酸アミド) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `noted`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `noted` (Entry: `7359`)
- **JP (MHLW)**: `noted`
- **ASEAN (ACD)**: `none`

- **KR** [noted]: 2~5% — MFDS Functional Cosmetics Notice Annex 4: 2.0~5.0% for brightening claim (no upper limit as general skin conditioning ingredient). (기능성화장품 심사에 관한 규정 [별표4])
- **CN** [noted]: — —  (化妆品安全技术规范(2015년판) — 전수 검색)
- **JP** [noted]: — — Japan MHLW Approved Quasi-Drug Active Ingredient for anti-wrinkle and brightening (labeled as Nicotinamide / ニコチン酸アミド). (MHLW Quasi-Drug Active Standards)

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 15% — NMPA IECIC (2025) Entry 07664 (2025)
- **cn_iecic_max** (rinse_off): ≤ 10% — NMPA IECIC (2025) Entry 07664 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 5.5 – 7
- **Max Process Temp**: ≤ 75°C
- **Synergy Pairings**: ZINC PCA, TRANEXAMIC ACID, NAG (ACETYL GLUCOSAMINE), 3-O-ETHYL ASCORBIC ACID, PANTHENOL
- **Incompatibilities**: CRITICAL WARNING 1: Hydrolyzes into Nicotinic Acid (Niacin) at pH < 4.5 or high heat, causing immediate vasodilation, erythema, and stinging ('Niacin Flush'); strictly maintain pH 5.5~7.0 and use low-nicotinic-acid grade (<100 ppm); WARNING 2: High concentrations (≥10%) may leave white crystalline powder residue ('chalking') on skin upon drying; co-formulate with Propanediol or Methyl Gluceth-20

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: NIACINAMIDE | CAS No.: 98-92-0 | EC No.: 202-713-4
  - Origin: VITAMIN | Functions: 
  - Physicochemical Profile: Formula C6H6N2O | MW 122.12 g/mol | LogP -0.37 | Ionic Nature: non-ionic | PubChem CID 936
  - Official Regional Label Names: US [NIACINAMIDE] · EU [NIACINAMIDE] · CN [烟酰胺] · JP [ナイアシンアミド] · JP Quasi-Drug [ニコチン酸アミド]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Biologically active amide form of Vitamin B3 and essential precursor to coenzymes NAD+ and NADP+. Inhibits melanosome transfer from melanocytes to keratinocytes via PAR-2 modulation, boosts de novo synthesis of ceramides and free fatty acids to fortify the stratum corneum barrier, and downregulates sebaceous lipogenesis.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: NOTED | EU: NONE | US: NONE | CN: NOTED | JP: NOTED | ASEAN: NONE (CN IECIC (2025) Entry No. 7359 (烟酰胺))
  - [CN / COMPOSITION / noted]: 
  - [KR / CLAIM / noted] (Max 5.0%): MFDS Functional Cosmetics Notice Annex 4: 2.0~5.0% for brightening claim (no upper limit as general skin conditioning ingredient).
  - [JP / OFFICIAL / noted]: Japan MHLW Approved Quasi-Drug Active Ingredient for anti-wrinkle and brightening (labeled as Nicotinamide / ニコチン酸アミド).
  - 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: 2.0 ~ 15.0% (Median 5.0%, Ref: DSM Niacinamide PC Monograph, MFDS Functional Notice & CIR Assessment) — Melanosome transfer inhibitor, sebum regulator & barrier ceramide booster
  - [emulsion_cream] Typical range: 2.0 ~ 10.0% (Median 4.0%, Ref: CIR Niacinamide Safety Assessment & MFDS Annex 4) — Brightening functional cream & barrier-strengthening lotion active
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase or Cool-down Phase (< 70°C)
  - Optimal pH Range: pH 5.5 ~ 7.0 | Max Process Temp: Max 75°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: CRITICAL WARNING 1: Hydrolyzes into Nicotinic Acid (Niacin) at pH < 4.5 or high heat, causing immediate vasodilation, erythema, and stinging ('Niacin Flush'); strictly maintain pH 5.5~7.0 and use low-nicotinic-acid grade (<100 ppm)
  - Incompatibility / Caution: WARNING 2: High concentrations (≥10%) may leave white crystalline powder residue ('chalking') on skin upon drying; co-formulate with Propanediol or Methyl Gluceth-20
  - Synergy Pairings: ZINC PCA, TRANEXAMIC ACID, NAG (ACETYL GLUCOSAMINE), 3-O-ETHYL ASCORBIC ACID, PANTHENOL | Reference Trade Names: Niacinamide PC (DSM), Vitagen™ B3
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 38722460 (2024, Drug Deliv Transl Res): Niacinamide: a review on dermal delivery strategies and clinical evidence
  - PMID 34844552 (2021, Recent Adv Antiinfect Drug Discov): Cosmeceutical Aptitudes of Niacinamide: A Review
  - PMID 16029679 (2005, Dermatologic Surgery): Niacinamide

## 6. Linked PubMed Literature
- [PMID: 38722460] Niacinamide: a review on dermal delivery strategies and clinical evidence — *Drug Deliv Transl Res* (2024)
- [PMID: 34844552] Cosmeceutical Aptitudes of Niacinamide: A Review — *Recent Adv Antiinfect Drug Discov* (2021)
- [PMID: 16029679] Niacinamide — *Dermatologic Surgery* (2005)
- [PMID: 12100180] The effect of niacinamide on reducing cutaneous pigmentation and suppression of melanosome transfer — *British Journal of Dermatology* (2002)
- [PMID: 42278444] Skin Cancer Prevention and Antiaging: Role of Nicotinamide. — *Int J Mol Sci* (2026)
- [PMID: 42168650] Fast, easy and green method for the first quantification of niacinamide in serums and creams by digital image analysis using iron (III) chloride — *Mikrochim Acta* (2026)
- [PMID: 42152519] Multitargeted Modulation of Skin Dullness by HNHT Formulation: Synergistic Inhibition of Melanogenesis, Glycation, and Lipofuscin Deposition — *J Cosmet Dermatol* (2026)
- [PMID: 42108609] Efficacy of a Topical Formulation on Skin Hydration and Barrier Function in Individuals With Xerosis: A 28-Day Randomized, Split-Leg, Untreated-Controlled Trial — *J Cosmet Dermatol* (2026)
- [PMID: 22028749] Evaluation of the efficacy and tolerance of a topical serum with 5% niacinamide in the treatment of melasma — *Dermatology Research and Practice* (2011)
- [PMID: 15916302] Niacinamide: A B vitamin that improves aging facial skin appearance — *Dermatologic Surgery* (2005)
- [PMID: ] PubChem Compound Summary: Niacinamide — *PubChem Compound Database* (2026)
- [PMID: 42250416] Stability and dermal safety of Ti(3)C(2)T(x) MXenes for potential skin-interfaced biosensor applications. — *Environ Int* (2026)
- [PMID: 42220732] Successful Therapeutic Approach to Facial Hyperpigmentation Secondary to Addison's Disease: A Case Report and Literature Review — *Cureus* (2026)
- [PMID: 42206507] Design and evaluation of multi-target AGEs/ALEs inhibitors for potential application in skin anti-aging — *Future Med Chem* (2026)
- [PMID: 42188421] An Injectable Biopolymer Hydrogel Complex (PN/HA/B3) for Facial Skin Redensification and General Rejuvenation: Clinical Report on Device Safety and Efficacy — *J Funct Biomater* (2026)