; and (D) whether warnings or recommendations in a cosmetic product label, as part of any conditions of use or tolerances imposed by the Secretary in a determination described in subparagraph (B) of subsection (d)(4), would be necessary and appropriate to help ensure the safety of the ingredient or nonfunctional constituent (or category thereof). (2) Minor adverse reactions The Secretary may not consider a cosmetic ingredient or nonfunctional constituent (or category thereof) harmful under paragraph (1) solely because it can cause minor adverse health reactions, such as minor transient allergic reactions or minor transient skin irritations, in some users. (3) Data and information (A) Required information A determination that a cosmetic ingredient or nonfunctional constituent (or category thereof) is safe in cosmetics under this section shall be based upon adequate evidence submitted or otherwise known to the Secretary, which shall include full reports of all available studies, published or unpublished, that are adequately designed to show whether the ingredient or nonfunctional constituent is safe. Such studies may include in vitro and in silico studies and epidemiological studies, biomonitoring studies, and studies focused on various points during the lifespan of the subject, that use scientifically valid methodology. (B) Additional relevant information The Secretary shall consider any other relevant information related to the safety of a cosmetic ingredient or nonfunctional constituent (or category thereof), including— (i) adverse event reports; (ii) findings and information from State, Federal, national, and international entities and other bodies composed of scientific and medical experts; (iii) if the ingredient or nonfunctional constituent (or category thereof) is lawfully used or present in other products regulated by the Secretary, the scientific basis for such use