Cosmetics · Quasi-drug actives

Niacinamide

ナイアシンアミド (Naiashin amido)

Also known as: Nicotinamide, Vitamin B3

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At a glance

CategoryCosmetics
INCI nameNiacinamide
Japanese labeling nameナイアシンアミド
Common Japanese notationsナイアシンアミド, ニコチン酸アミド
CAS number98-92-0
OriginSynthetic (B-vitamin)
Typical functionsQuasi-drug active for anti-wrinkle (シワ改善) where 厚生労働省 (Ministry of Health, Labour and Welfare)-approved, Skin conditioning, Antioxidant
Regulatory status in JapanNiacinamide is among the 厚生労働省 (Ministry of Health, Labour and Welfare)-approved quasi-drug active ingredients for anti-wrinkle (シワ改善) claims. General cosmetic use without quasi-drug claims is also permitted under the JSCI dictionary.

Niacinamide — also known as nicotinamide or vitamin B3 — is one of the most versatile actives in modern Japanese cosmetics. In Japan it has both general cosmetic use and approved quasi-drug status for specific functional claims, including anti-wrinkle (シワ改善) — a category that opened up to cosmetic-adjacent claims relatively recently in the Japanese regulatory framework.

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Browse Japanese OEM manufacturers that build products in this category. Filter by small lot, certifications, prefecture.

Classification

Tags below link to other ingredients sharing the same attribute, so you can pivot from one ingredient to its peers.

Common OEM product categories

Finished-product categories where Japanese OEM manufacturers commonly formulate with this ingredient.

  • Medicated anti-wrinkle products (薬用シワ改善)
  • Brightening serums
  • Moisturizing skincare
  • Sensitive skin lines

Ingredient profile

Niacinamide is the amide form of niacin (vitamin B3). It functions as a precursor to NAD+ and NADP+ in cellular metabolism, and in topical formulations contributes to multiple skin-function pathways including ceramide synthesis support.

OEM applications

In Japanese cosmetics, niacinamide appears in medicated anti-wrinkle products, brightening serums, and general moisturizing skincare. It is one of the most-used quasi-drug-eligible actives across the Japanese market.

Regulatory classification in Japan

Approved as a quasi-drug active for specific claims including anti-wrinkle. General cosmetic use is also permitted under the JSCI dictionary.

Regulatory classification in other markets

EUListed in CosIng. Permitted for cosmetic use.
USAINCI recognized. Widely used.
ChinaPermitted per IECIC listings.
KoreaApproved as a functional cosmetic ingredient under KFDA / MFDS for whitening and anti-wrinkle claims.

Market reference formulations

Example finished products will be added after each product's current full ingredient list has been verified.

All brand names and product names referenced anywhere on this site are the property of their respective owners. Example entries are provided for informational purposes only and do not imply endorsement.

Typical OEM use levels

Formulation ranges per finished-product application. Verify against the cited source before production.

ApplicationTypical rangeRegulatory limitNotes
Quasi-drug whitening / wrinkle-care serum (Japan)2–5%Capped per 厚生労働省 quasi-drug notification per productApproved as both whitening (美白) and anti-wrinkle (シワ改善) active(厚生労働省 医薬部外品有効成分通知)
Cosmetic moisturizer / serum (general)2–10%Higher levels (>5%) can cause flushing in sensitive skin

Stability & compatibility

pH range
pH 5.0–7.0
Temperature
Can hydrolyze to nicotinic acid at extreme pH or prolonged heat; standard cosmetic processing is fine
Incompatibilities
  • L-ascorbic acid at low pH (potential niacin formation under heat)

Very stable in finished products. Combine with vitamin-C derivatives (ascorbyl glucoside, MAP) instead of pure L-ascorbic acid for stable brightening blends.

Storage requirements

How the receiving OEM facility needs to handle inbound raw material.

Temperature
Room temperature ≤30°C
Conditions
Dry, sealed; protect from prolonged moisture
Shelf life
36 months sealed

EU CosIng + supplier SDS

Supply concentration

Where this ingredient comes from — useful for single-source-risk planning.

Primary regions
Synthetic; majority of global volume from China and India
Import dependence
Japan imports nearly all cosmetic / pharma-grade niacinamide

Certifications commonly available

Certification schemes commonly obtainable for this raw material. Always confirm the specific supplier's current certificate before contracting.

SchemeAvailability
GMP (cosmetic / quasi-drug)Standard
HalalCommonMajor suppliers (DSM, Lonza, etc.) hold Halal cert
KosherCommon
VeganCommonSynthetic origin
COSMOSRareStandard synthetic niacinamide is not COSMOS-Approved; bio-derived versions exist

Alternative ingredients

Related ingredients commonly evaluated as substitutes.

Quick answers

What is Niacinamide?
Niacinamide — also known as nicotinamide or vitamin B3 — is one of the most versatile actives in modern Japanese cosmetics. In Japan it has both general cosmetic use and approved quasi-drug status for specific functional claims, including anti-wrinkle (シワ改善) — a category that opened up to cosmetic-adjacent claims relatively recently in the Japanese regulatory framework.
What is the regulatory status of Niacinamide in Japan?
Niacinamide is among the 厚生労働省 (Ministry of Health, Labour and Welfare)-approved quasi-drug active ingredients for anti-wrinkle (シワ改善) claims. General cosmetic use without quasi-drug claims is also permitted under the JSCI dictionary.
What products typically use Niacinamide?
Medicated anti-wrinkle products (薬用シワ改善) / Brightening serums / Moisturizing skincare / Sensitive skin lines
Where does Niacinamide come from?
Synthetic (B-vitamin)
What is the INCI / JSCI labeling name for Niacinamide?
INCI: Niacinamide / JSCI: ナイアシンアミド

FAQ for OEM buyers

Q. What quasi-drug claims can niacinamide anchor in Japan?

Niacinamide is approved as a quasi-drug active for both whitening (美白) and anti-wrinkle (シワ改善) claims in Japan; the latter via Pola/Shiseido-led approvals around 2016–2017. Finished products with these claims must be filed as quasi-drugs.

Sources · Last reviewed: 2026-04-26

  • 厚生労働省 (Ministry of Health, Labour and Welfare) — quasi-drug actives for whitening and anti-wrinkle (niacinamide)
Q. What is the typical Japan quasi-drug use level?

Anti-wrinkle quasi-drugs commonly use niacinamide at 3–4% (the Pola Wrinkle-Shot reference level was around 4%); whitening quasi-drugs typically use it at 2–5%.

Sources · Last reviewed: 2026-04-26

  • Industry knowledge — Japanese niacinamide quasi-drug formulations

Industry-knowledge claim — not yet pinned to a single primary source

Q. Are there any China NMPA registration notes?

Niacinamide is on China's IECIC inventory and is one of the most-used brightening actives in NMPA-registered cosmetics; no special-purpose cosmetic filing is required for general-cosmetic brightening positioning.

Sources · Last reviewed: 2026-04-26

  • China NMPA — IECIC (Inventory of Existing Cosmetic Ingredients in China)
Q. What stability and incompatibility issues should I watch for?

Niacinamide is highly water-soluble and stable across pH 5–7; it can form niacin (with associated odor) under prolonged low pH or high temperature, so avoid hot processing under acidic conditions. Combination with low-pH L-ascorbic acid is generally fine in modern formulations contrary to older claims.

Sources · Last reviewed: 2026-04-26

  • Industry knowledge — niacinamide formulation practice

Industry-knowledge claim — not yet pinned to a single primary source

Use cases

  • Medicated anti-wrinkle cream / eye cream

    Positioning
    Pola Wrinkle Shot-style premium anti-wrinkle quasi-drug
    Typical usage level
    3–4% (Japan quasi-drug)
    Formulation notes
    pH 5–6.5; combine with peptides; quasi-drug filing required for シワ改善 claim.

    Sources

    • Industry knowledge — Japanese anti-wrinkle quasi-drug category

    Industry-knowledge claim — not yet pinned to a single primary source

  • Medicated whitening serum

    Positioning
    Multi-claim medicated whitening line
    Typical usage level
    2–5% (Japan quasi-drug)
    Formulation notes
    Combined with tranexamic acid or ascorbyl glucoside in dual-active products.

    Sources

    • Industry knowledge — Japanese whitening quasi-drug category

    Industry-knowledge claim — not yet pinned to a single primary source

  • Brightening toner / lotion

    Positioning
    Mass-market daily-use brightening cosmetic
    Typical usage level
    2–5%
    Formulation notes
    Water-soluble; widely accepted across all major export markets including China.

    Sources

    • Industry knowledge — global brightening cosmetic

    Industry-knowledge claim — not yet pinned to a single primary source

  • Pore / sebum-control gel

    Positioning
    Combination skin / oily skin daily care
    Formulation notes
    Used at 2–5% with salicylic acid (within Japan quasi-drug acne approvals) for combination claims.

    Sources

    • Industry knowledge — pore-care segment

    Industry-knowledge claim — not yet pinned to a single primary source

  • Sheet mask

    Positioning
    Brightening + barrier daily mask
    Formulation notes
    Stable at 2–5% in mask serum; pair with HA and panthenol.

    Sources

    • Industry knowledge — Asian sheet mask category

    Industry-knowledge claim — not yet pinned to a single primary source

Search the academic literature

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Official regulatory databases

External links to public Japanese / international regulatory authorities. We are not affiliated.

References

  1. Japan 医薬品医療機器総合機構 PMDA (Pharmaceuticals and Medical Devices Agency) — quasi-drug active ingredient approval registry
  2. EU CosIng entry: Niacinamide

Last updated: 2026-04-22. Ingredient entries are reviewed at least annually against current regulatory listings.

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