Does the final rule include cosmetic products that contain drug ingredients, such as sunscreens?
OTC Drug-cosmetic products are included in the final rule. These products contain drug ingredients and are marketed for both drug and cosmetic uses. Drug-cosmetics have specific warnings and directions that consumers need to know so they can use these products effectively and with less risk. • What about the elderly? Will they be able to read the new labels? It’s quite true that the elderly have had difficulty reading OTC drug labels in the past. FDA reviewed several studies that included elderly consumers. One study showed that a 4.5-point minimum type size is not readable, and another study presented information that 6.7-point is a readability threshold for persons over age 60 years. Recognizing that factors other than type size can also enhance readability and that there are space constraints for labeling on drug packages, the agency chose to require a minimum type size of 6 point along with graphic labeling features. • Why didn’t FDA require a larger type size on labels? FDA resear
