Beta Arbutin
Skin lightening agent; tyrosinase inhibitor
Limited Data
Insufficient safety data available. Consider enriching this ingredient.
Details
Description
Skin lightening agent; tyrosinase inhibitor
Purpose
Function
Skin lightening agent; tyrosinase inhibitor
Profile
Properties
Silicone
Silicone free
Compliance
Regulatory Status
EU
Restricted
Safety
GOOD
US
Permitted
EU Max Concentration7%
Absorptionlow
Sensitizationlow
MoSadequate
NOAEL300 mg/kg
ConcernModerate
Verdict
EU restricted to 7% in face creams under Annex III (Regulation EU 2024/996, entry 378) with hydroquinone impurity limits; safe per SCCS/1642/22. US permitted without concentration limits. Residual concern from potential hydroquinone release via microbial hydrolysis.
US Note
Beta-Arbutin is not restricted by the FDA and may be used freely in cosmetic products without concentration limit. Not classified as an OTC drug active ingredient. No completed CIR monograph exists specifically for beta-arbutin. Widely sold OTC in skin brightening products. No federal hydroquinone impurity limits imposed on arbutin-containing cosmetics in the US.
Assessment
Ratings
Reference
Identifiers
No registry identifiers available for this ingredient.