effect in humans of relevant exposure to the ingredient or non-functional constituent or to any chemically or pharmacologically related substances from use in cosmetics or other products with similar routes of exposure under recommended or suggested conditions of use or their customary use, to the extent adequate data is available for analysis. In appropriate cases, the Food and Drug Administration may consider available information on the total exposure to an ingredient or non-functional constituent from all sources. (C) Whether warnings or recommendations in a product label required under section 614, as part of any conditions of use or tolerances imposed by the Food and Drug Administration, would be necessary and appropriate to help ensure the safety of the ingredient or non-functional constituent. (3) Data and information (A) Required information A determination that an ingredient or non-functional constituent is safe in cosmetics shall be based upon adequate evidence submitted or otherwise known to the Food and Drug Administration, which shall include full reports of all available studies, published or unpublished, that are adequately designed to show whether the ingredient or non-functional constituent is safe.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 Food and Drug Administration shall consider any other relevant information related to the safety of the ingredient or non-functional constituent, including— (i) adverse event reports