Type: Ingredient entity — regulatory boundary & claim record
Topic: Sodium Hyaluronate (소듐하이알루로네이트) — cosmetic ingredient / regulatory boundary
Evidence basis: KCIA ingredient naming (code 1265); MFDS functional-cosmetic notification Annex 4 (non-listing, 고시 제2025-88호); MFDS cosmetic safety standard Annexes 1–2 (non-listing, 고시 제2026-19호); NEDRUG prescription-drug records; PubChem chemical identity
Last Verified: 2026-07-13
This page does not make treatment, disease prevention, or efficacy claims. See the Evidence Boundaries section.
Sodium Hyaluronate (Korean: 소듐하이알루로네이트) is the sodium salt of hyaluronic acid and one of the most common moisturizing ingredients in cosmetics. In Korea’s ingredient system it is recorded by the KCIA (ingredient code 1265) with the compounding purpose of skin-conditioning agent (피부컨디셔닝제). This page organizes what that listing does and does not establish.
The KCIA listing is a naming and compounding-purpose layer. It confirms that Sodium Hyaluronate is a recognized cosmetic ingredient, but it is not by itself the basis for a functional (기능성) claim. Separately, this entity sits against two important regulatory boundaries: it is not listed as a functional-cosmetic active in Annex 4, and the same substance — in injectable form — is a prescription drug. This record maps where the cosmetic-ingredient status ends.
Because “hyaluronic acid” is marketed with molecular-weight labels (HMW / LMW / oligo) that do not correspond to separate KCIA codes, and because the injectable drug form shares the same substance name, Sodium Hyaluronate is a frequent source of claim confusion. This page keeps the cosmetic-naming layer, the functional-cosmetic layer, and the drug layer separate.
Ingredient Snapshot
| Field | Value |
|---|---|
| Ingredient Name | Sodium Hyaluronate |
| Korean Name | 소듐하이알루로네이트 |
| INCI Name | Sodium Hyaluronate |
| Synonyms | Hyaluronic acid sodium salt |
| CAS No. | 9067-32-7 |
| Molecular Formula | Polymer — sodium salt of hyaluronic acid (PubChem CID 3084049 lists C28H44N2NaO23+ for a representative unit) |
| KCIA Ingredient Code | 1265 |
| Ingredient Type | Cosmetic ingredient |
| Cosmetic Role | Skin-conditioning agent (KCIA 피부컨디셔닝제) |
| Supplement Function | Unknown / Not applicable |
| Status | To Review |
Identity: CAS 9067-32-7, PubChem CID 3084049, UNII YSE9PPT4TH, InChIKey YWIVKILSMZOHHF-QJZPQSOGSA-N (from PubChem/UNII). Sodium Hyaluronate is a polymer, so a single small-molecule formula does not fully describe it. KCIA code 1265 confirms cosmetic naming and compounding purpose only.
Regulatory Records
| Record Type | Jurisdiction | Issuing Body | Record Number | Finding | Source |
|---|---|---|---|---|---|
| Functional-cosmetic notification — non-listing (negative) | Korea (KR) | MFDS | 고시 제2025-88호 (별표4) | The HA family (KCIA 4822/1265/5655/7511/4152) across all six functional-cosmetic categories is not listed. No variant qualifies for the functional-cosmetic fast track. | MFDS 별표4 (law.go.kr) |
| Functional-cosmetic category — absence (negative) | Korea (KR) | MFDS | 고시 제2025-88호 (별표4) | Annex 4 has no standalone “moisturizing” functional category. Only six categories exist (UV protection, whitening, wrinkle improvement, hair-color change, hair removal, acne relief). | MFDS 별표4 (law.go.kr) |
| Cosmetic safety standard — non-listing (negative) | Korea (KR) | MFDS | 고시 제2026-19호 (별표1·2) | The HA family is not listed in Annex 1 (prohibited raw materials) or Annex 2 (restricted raw materials). This is a boundary record, not an assertion of absolute safety. | MFDS 안전기준 별표1·2 (mfds.go.kr) |
| Prescription-drug boundary | Korea (KR) | MFDS / NEDRUG | 품목허가 (니론주 201905827 · 삼성히알루론산주 201707367) | Sodium hyaluronate is also a prescription (Rx) intra-articular injection. Indication (verbatim): “슬관절의 골관절염, 견관절주위염 치료.” ATC M09AX01. These drug indications must not be transferred to cosmetic or supplement claims. | NEDRUG 품목허가 (nedrug.mfds.go.kr) |
All four records are directly verified. Three are negative/boundary findings (non-listing), and one is a prescription-drug boundary.
Claim Safety Matrix
⚠️ Claim classification below reflects the DB record and requires human regulatory review before publication.
| Claim Text | Claim Type | Why It Matters | Safer Alternative Wording | Source |
|---|---|---|---|---|
| General “moisturizing” / “hydration” wording for Sodium Hyaluronate | Caution | The KCIA compounding purpose (skin-conditioning agent) is a naming layer, not a standalone functional basis. General moisturizing wording may be used within that factual scope but cannot be expanded into a functional (기능성) claim. | State the fact: “listed by KCIA (code 1265) as a skin-conditioning agent,” and keep wording within general cosmetic use. | KCIA 성분사전 (code 1265) |
| “Functional moisturizing” / “MFDS-notified moisturizing functionality” | Caution | Annex 4 has no moisturizing functional category, so there is no fast-track functional status to claim. “기능성 / 고시 / 인정” wording for moisturizing risks violating the Cosmetics Act. | Avoid “기능성/고시/인정.” Describe only general cosmetic moisturizing use. | MFDS 고시 제2025-88호 별표4 (negative) |
| Expanding the KCIA “moisturizer” tag of Hydrolyzed HA (code 5655) into Cosmetics-Act functional moisturizing | Caution | The KCIA naming layer (“registered as a moisturizer”) is a fact quote; it is not the same as the Cosmetics-Act functional layer. The two layers must stay separate. | Quote only “registered in the KCIA classification as a moisturizer”; do not extend to functional status. | KCIA 성분사전; MFDS 별표4 (negative) |
| “Joint health” / “intra-articular injection” / “treats osteoarthritis / periarthritis” | Prohibited | Sodium hyaluronate is a prescription drug (intra-articular injection) with MFDS-approved indications. Transferring those drug indications to a cosmetic or supplement claim creates a risk of the product being mistaken for a drug. | Do not use any drug indication. Keep to cosmetic-ingredient facts only. | NEDRUG 품목허가 (니론주·삼성히알루론산주) |
Evidence Boundaries: What This Page Does Not Claim
The following claims are outside the scope of this ingredient record:
Not a functional cosmetic. Sodium Hyaluronate is not listed in Annex 4; there is no notified moisturizing functionality to claim. “기능성/고시/인정 moisturizing” wording is not supported.
No drug indications. The injectable prescription-drug form treats joint conditions; those indications belong to the drug, not to Sodium Hyaluronate as a cosmetic ingredient, and must not be transferred to cosmetic or supplement claims.
No molecular-weight efficacy differentiation. HMW / LMW / oligo labels are marketing terms without separate KCIA codes or first-source efficacy evidence, and are not asserted here.
Not an assertion of absolute safety. Non-listing in the safety-standard annexes is a boundary fact; it does not mean “legally guaranteed safe.”
No disease treatment, prevention, or individual-result guarantees.
Related Entities
Related Ingredients
- Hyaluronic Acid — the parent acid (Sodium Hyaluronate is its sodium salt)
- Hydrolyzed Hyaluronic Acid (KCIA 5655) — related variant (KCIA “moisturizer” tag)
- Hydrolyzed Sodium Hyaluronate (KCIA 7511); Sodium Hyaluronate Crosspolymer-6 (KCIA 4152) — related variants
Related Product Types
- General moisturizing cosmetics (non-functional)
- Prescription intra-articular injection (separate drug domain — not a cosmetic)
Related Claims
- KCIA naming-layer fact (skin-conditioning agent, code 1265)
- Functional-cosmetic non-listing boundary (no moisturizing category)
- Prescription-drug boundary (do not transfer drug indications)
Related Regulatory Concepts
- 기능성화장품 (functional cosmetics) — Annex 4 categories
- 화장품 안전기준 (cosmetic safety standard) — Annexes 1–2
- 전문의약품 (prescription drug) — cosmetic/drug boundary
Source Transparency Note
This page uses the following source classification:
| Source | Role | Authority Scope | Limit |
|---|---|---|---|
| KCIA 성분사전 (code 1265) | Naming | INCI name, synonym, Korean name, compounding purpose | 기능성 claim 근거 불가 (naming layer only) |
| MFDS 고시 제2025-88호 (별표4) | Regulatory (negative) | Functional-cosmetic non-listing; category absence | 화장품 한정 |
| MFDS 고시 제2026-19호 (별표1·2) | Regulatory (negative) | Safety-standard non-listing (boundary) | “절대 안전” 단정 불가 |
| NEDRUG 품목허가 | Regulatory (drug boundary) | Prescription-drug existence and indication | 화장품/건기식 claim 으로 전용 불가 |
| PubChem | Chemical identity | CAS 9067-32-7, CID 3084049 | 규제·claim 근거 아님 |
KCIA is used for naming/synonym confirmation only and is not used as the basis for any functional or medical claim.
Frequently Asked Questions
Is Sodium Hyaluronate a functional cosmetic ingredient in Korea?
No. Sodium Hyaluronate is a KCIA-listed cosmetic ingredient (code 1265, skin-conditioning agent), but it is not listed in Annex 4 of the functional-cosmetics regulation. Annex 4 has no moisturizing category, so there is no notified moisturizing functionality for Sodium Hyaluronate.
Can Sodium Hyaluronate cosmetic claims mention joint treatment or injections?
No. Sodium hyaluronate is also a prescription intra-articular injection with approved joint indications. Those drug indications must not be transferred to Sodium Hyaluronate cosmetic or supplement claims.
Do HMW, LMW, or oligo hyaluronic acid labels mean different regulated ingredients?
No. For Sodium Hyaluronate these molecular-weight labels are marketing terms; they do not correspond to separate KCIA codes or first-source efficacy evidence in this record.
What can be said about Sodium Hyaluronate’s moisturizing role?
General moisturizing wording can be used within the KCIA fact that Sodium Hyaluronate is listed as a skin-conditioning agent (code 1265), but it cannot be expanded into a functional (기능성) claim.