Draft bill 441.

Summary.

The draft bill proposes recognizing sunscreens as essential products for health use and classifying them as over-the-counter medicines for protection against ultraviolet radiation. It defines sunscreen as a topical product that protects the skin from the harmful effects of that radiation through absorption, reflection, or dispersion. Classification as an over-the-counter medicine would apply to sunscreens with a sun protection factor (SPF) equal to or greater than fifteen (15), which would fall under the regulation of the Ministry of Health (Ministerio de Salud).

The Ministry of Health would establish the technical criteria governing classification, health registration, importation, distribution, and marketing of these products. Their labels would have to display clearly and visibly the sun protection factor (SPF), the type of protection (UVA/UVB), directions for use, and health warnings. These provisions link the proposed classification to the identification and circulation requirements for the sunscreens covered by the draft bill.

The State would promote sunscreen use in educational centers, public institutions, and outdoor activities, especially among vulnerable populations and workers exposed to the sun. The Ministry of Health would conduct ongoing educational campaigns on sunscreen use as a measure to prevent disease. The Executive Branch (Órgano Ejecutivo), through the Ministry of Health, would issue implementing regulations within no more than ninety (90) days from promulgation. The proposed law would take effect upon promulgation.

Under a transitional provision, the Ministry of Health would have a maximum of ninety (90) calendar days from the law’s entry into force to adapt the regulatory framework and reclassify existing health registrations for sunscreens. During that period, products with an SPF equal to or greater than fifteen (15) would be provisionally recognized as over-the-counter medicines without an additional procedure for health registration holders. The competent authorities would take the measures needed to maintain continuity in their importation, distribution, and marketing under the new classification. Once that period expires, no product meeting the conditions of the proposed law could be treated or marketed under a different classification.

The public bodies concerned are the Ministry of Health and the Executive Branch, together with the educational centers and other public institutions where use would be promoted. The provisions would also reach health registration holders and could concern sunscreen importers, distributors, and sellers, as well as vulnerable populations and workers exposed to the sun.