Skincare University

Cosmetics vs. quasi-drugs—what "active ingredient" really means

LEVEL 3
The Truth About Ingredient Labels

※ The information in this section is based on Japanese cosmetics regulations (Pharmaceutical and Medical Device Act / 薬機法). Ingredient classifications, permitted concentrations, and labeling requirements may differ in your country or region.
LEVEL 3 The Truth About Ingredient Labels

In Japan, cosmetic products are classified into "general cosmetics" and "quasi-drugs (medicated cosmetics)." Understanding this distinction is crucial for interpreting ingredient labels.

General Cosmetics

Full ingredient disclosure is required, but there is no obligation to disclose concentrations. You can claim "Contains XX" regardless of the amount.

Quasi-Drugs

"Active ingredients" and their concentrations must be specified. Only ingredients whose efficacy has been recognized by the Ministry of Health, Labour and Welfare may be used. Efficacy claims such as "wrinkle improvement" and "skin brightening" are permitted. In other words, the "active ingredient" label on a quasi-drug is proof that a government-approved ingredient is present at its approved concentration.

General Cosmetics vs Quasi-Drugs General Cosmetics Quasi-Drugs Full ingredient list required ○ Active ingredients + conc. specified ○ Concentrations not disclosed × MHLW-approved ○ Efficacy claims restricted × Efficacy claims permitted ○ "Active ingredient" label = proof that a gov't-approved ingredient is at its approved concentration

Limitations of Quasi-Drugs

However, quasi-drugs also have limitations. There is no obligation to disclose concentrations for non-active ingredients. Newer active ingredients not on the approved list cannot be used. The approval process cost serves as a barrier to entry for smaller brands.

The ideal is for brands to voluntarily provide transparency across all ingredients.

KAIAN develops skincare products based on scientific evidence.
Feel free to ask questions about ingredients and formulations.

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