Menthyl Anthranilate

The Food and Drug Administration (FDA) reviewed the safety and efficacy of Menthyl Anthranilate and approved its use as an active ingredient in Over-the-Counter (OTC) sunscreen drug products at concentrations up to 5%. When used in OTC drug products, Menthyl Anthranilate is called Meradimate.

The Cosmetic Ingredient Review (CIR) Expert Panel has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.
Link to FDA Code of Federal Regulations for Meradimate (Mentyl Anthranilate)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Menthyl Anthranilate is not specifically listed in the Cosmetics Directive of the European Union. Therefore, it may not be used in products that protect the skin from the sun. In Europe, it may be used to protect cosmetics and personal care products from UV rays to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...

Health Canada permits the use of Menthyl Anthranilate in sunscreen products at a maximum concentration of 5%.