; (ii) subject to a final order under this section; or (iii) subject to a final sunscreen order (as defined in section 586(2)(A)). (C) Information demonstrating prima facie safe nonprescription marketing and use Information specified in this subparagraph, with respect to a request described in subparagraph (A)(i), is— (i) information sufficient for a prima facie demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the United States as a nonprescription drug under comparable conditions of use; (ii) if the drug has not been previously marketed in the United States as a nonprescription drug, information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section 802(b)(1)(A) or designated by the Secretary in accordance with section 802(b)(1)(B)— (I) for such period of time as needed to provide reasonable assurances concerning the safe nonprescription use of the drug; and (II) during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the Secretary for such monitoring purposes, including for adverse events associated with nonprescription use of the drug