Tolnaftate

INCI: TOLNAFTATE

CAS Number
2398-96-1
Function
Antifungal agent (OTC drug in the US; not a standard cosmetic function)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status prohibited
US Notes Listed on the Cosmetic Ingredient Hotlist (prohibited/restricted)

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Drug substance โ€” inclusion in cosmetics triggers drug classification issues in both EU and US; prohibited in Canadian cosmetics

โš ๏ธ
Concern Level: High

Frequently Asked Questions

Is Tolnaftate safe in cosmetics?

Drug substance โ€” inclusion in cosmetics triggers drug classification issues in both EU and US; prohibited in Canadian cosmetics The EU classifies Tolnaftate as "permitted". Safety rating: MODERATE.

Is Tolnaftate allowed in the EU?

Tolnaftate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Tolnaftate do in cosmetics?

Tolnaftate functions as: Antifungal agent (OTC drug in the US; not a standard cosmetic function). It is classified as a cosmetic ingredient in our database. CAS number: 2398-96-1.

What is the Margin of Safety for Tolnaftate?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

๐Ÿ“ฑ

Is Tolnaftate in Your Products?

Scan any product label with Piro โ€” our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free โ†’

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Tolnaftate in your formulation.