# CERAMIDE NP (ceramide-np) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/ceramide-np
- **Standard INCI**: `CERAMIDE NP`
- **KR MFDS Standard Name**: `세라마이드엔피`
- **CAS No.**: `34354-88-6`
- **EC / EINECS No.**: `309-560-3`
- **Origin**: `synthetic`
- **Functions**: 모발컨디셔닝제, 피부컨디셔닝제
- **Molecular Formula / MW**: `C36H71NO4` (565.95 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 세라마이드엔피 |
| KR (Former Names) | 세라마이드3 |
| EU (CosIng 1223/2009) | CERAMIDE NP |
| US (PCPC / MoCRA INCI) | CERAMIDE NP |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 神经酰胺 NP |
| JP (JCIA / MHLW QD) | セラミドＮＰ (QD: Ｎ－ステアロイルフィトスフィンゴシン) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `6016`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 3.3% — NMPA IECIC (2025) Entry 05988 (2025)
- **cn_iecic_max** (rinse_off): ≤ 2% — NMPA IECIC (2025) Entry 05988 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 8
- **Max Process Temp**: ≤ 95°C
- **Synergy Pairings**: CHOLESTEROL, STEARIC ACID, PHYTOSPHINGOSINE, HYDROGENATED LECITHIN, OCTYLDODECANOL
- **Incompatibilities**: High melting point (93~98°C) and strong crystallization tendency; if not fully dissolved at 85~90°C in polar co-solvents (Octyldodecanol, DPG, Hydrogenated Lecithin), gritty crystals precipitate during storage

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: CERAMIDE NP | CAS No.: 34354-88-6 | EC No.: 309-560-3
  - Origin: SYNTHETIC | Functions: , 
  - Physicochemical Profile: Formula C36H71NO4 | MW 565.95 g/mol | LogP 11.4 | Ionic Nature: non-ionic | PubChem CID 57378373
  - Official Regional Label Names: US [CERAMIDE NP] · EU [CERAMIDE NP] · CN [神经酰胺 NP] · JP [セラミドＮＰ] · JP Quasi-Drug [Ｎ－ステアロイルフィトスフィンゴシン]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Non-hydroxy acyl phytosphingosine (Ceramide 3), the predominant ceramide species in human stratum corneum intercellular lipids. Self-assembles with cholesterol and free fatty acids into orthorhombic multi-lamellar lipid bilayers to restore barrier integrity and prevent transepidermal water loss.
■ [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. 6016 (神经酰胺 NP))
  - 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 3.3% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 2.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [emulsion_cream] Typical range: 0.01 ~ 2.0% (Median 0.2%, Ref: EvonikSK Sphingony / Ceramide III TDS & CIR Ceramides Assessment) — Skin-identical intercellular lamellar lipid barrier restorer
  - [aqueous_serum] Typical range: 0.01 ~ 0.5% (Median 0.05%, Ref: CIR Ceramide Safety Assessment) — Hydrogenated lecithin nano-liposomal barrier serum active
  - [anhydrous_balm] Typical range: 0.1 ~ 0.2% (Median 0.1%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, EVONIK 5)) — Anhydrous balm, oil & stick structural emollient
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Oil / Polyol Co-solvent Phase (Must heat to 85~90°C until 100% crystal-clear before emulsification, or use pre-liposomal dispersion)
  - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 95°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: High melting point (93~98°C) and strong crystallization tendency; if not fully dissolved at 85~90°C in polar co-solvents (Octyldodecanol, DPG, Hydrogenated Lecithin), gritty crystals precipitate during storage
  - Synergy Pairings: CHOLESTEROL, STEARIC ACID, PHYTOSPHINGOSINE, HYDROGENATED LECITHIN, OCTYLDODECANOL | Reference Trade Names: Ceramide III®, DS-Ceramide Y30
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 41758783 (2026, Skin Pharmacol Physiol): Monocentric, Vehicle-Controlled, Double-Blind Study to Assess the Short- and Long-Term Effects of a Ceramide NP C15-Cont
  - PMID 40682399 (2025, J Cosmet Dermatol): The Effectiveness and Safety of a Skin Care Product With Centella asiatica Leaf Extract, Ceramide NP, and Panthenol in S
  - PMID 40560383 (2025, Mol Pharm): Presence of Different Ceramide Species Modulates Barrier Function and Structure of Stratum Corneum Lipid Membranes: Insi

## 6. Linked PubMed Literature
- [PMID: 41758783] Monocentric, Vehicle-Controlled, Double-Blind Study to Assess the Short- and Long-Term Effects of a Ceramide NP C15-Containing Emollient on the Skin Microbiome and the Skin Barrier Function in Sensitive Skin. — *Skin Pharmacol Physiol* (2026)
- [PMID: 40682399] The Effectiveness and Safety of a Skin Care Product With Centella asiatica Leaf Extract, Ceramide NP, and Panthenol in Subjects With Sensitive Skin: A Prospective, Observational Study. — *J Cosmet Dermatol* (2025)
- [PMID: 40560383] Presence of Different Ceramide Species Modulates Barrier Function and Structure of Stratum Corneum Lipid Membranes: Insights from Molecular Dynamics Simulations — *Mol Pharm* (2025)
- [PMID: 40210432] Non-Invasive Depth Profiling of Base Cosmetic Formulations in the Skin Using Handheld Confocal Raman Spectroscopy — *J Biophotonics* (2025)
- [PMID: 39492723] Efficacy of Pseudo-Ceramide Absorption Into the Stratum Corneum and Effects on Transepidermal Water Loss and the Ceramide Profile: A Randomized Controlled Trial — *J Cosmet Dermatol* (2025)
- [PMID: 38140026] The Design and Optimization of Ceramide NP-Loaded Liposomes to Restore the Skin Barrier — *Pharmaceutics* (2023)
- [PMID: 37739524] Synthesis and self-assembling of hyaluronan grafted with ceramide NP for topical drug delivery — *Carbohydr Polym* (2023)
- [PMID: 37357654] Effects of winter indoor environment on the skin: Unveiling skin condition changes in Korea — *Skin Res Technol* (2023)
- [PMID: 36762491] Multilamellar ceramide core-structured microvehicles with substantial skin barrier function recovery — *J Mater Chem B* (2023)
- [PMID: 36676956] Positive Correlation of Triacylglycerols with Increased Chain Length and Unsaturation with ω-O-Acylceramide and Ceramide-NP as Well as Acidic pH in the Skin Surface of Healthy Korean Adults — *Metabolites* (2022)
- [PMID: 35864796] Ethosome Containing Ceramide as a Skin Carrier of Active Ingredients — *Curr Drug Deliv* (2023)
- [PMID: 37276158] Ceramide-Containing Adjunctive Skin Care for Skin Barrier Restoration During Acne Vulgaris Treatment — *J Drugs Dermatol* (2023)
- [PMID: 40408261] Topical supplementation with physiological lipids rebalances the stratum corneum ceramide profile and strengthens skin barrier function in adults predisposed to atopic dermatitis — *Br J Dermatol* (2025)
- [PMID: 38447864] Similar Alterations of the Stratum Corneum Ceramide Profile in Atopic Dermatitis, Psoriasis, and Ichthyosis: Results from a Systematic Review and Meta-Analysis — *J Invest Dermatol* (2024)
- [PMID: 23988654] Ceramide synthesis in the epidermis — *Biochim Biophys Acta* (2014)
- [PMID: 24055887] Ceramide signaling in mammalian epidermis — *Biochim Biophys Acta* (2014)
- [PMID: 11493117] Ceramide-dominant, barrier-repair lipids improve childhood atopic dermatitis — *Arch Dermatol* (2001)
- [PMID: ] PubChem Compound Summary: Ceramide NP — *PubChem Compound Database* (2026)