A Common FDA Refrain: BASF, L’Oreal Sunscreen TEAs Need More Information
This article was originally published in The Tan Sheet
After taking no action on sunscreen ingredient TEAs for a decade, FDA has found five applications to be insufficient since February, but is leaving the door open on future approval based on additional safety data.
You may also be interested in...
FDA’s proposed safety standards for sunscreen monograph ingredients might not align with safety evidence supporting current monograph ingredients. Without a safeguard, such as a grandfather clause, these ingredients could face challenges if FDA adopts stricter standards, NDAC committee members worry.
FDA says BASF must clarify whether tests studied bisoctrizole or the firm’s compound marketed as Tinosorb M, which combines bisoctrizole and other ingredients.
FDA says it needs additional data from L’Oreal on safety, efficacy and adverse events to determine GRASE for drometrizole trisiloxane.