Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2416
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2416
Character Range: 1152175–1153280

2416                                      GLYCOLIC ACID                                              E         Only for use in topical medicines for dermal application.
                                                                                                               Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose.
                                                                                                               When present as an excipient in sunscreens, the concentration in the medicine must be no more than 5%.
                                                                                                               When used as an excipient ingredient in other medicines the concentration in the medicine must be no more than 20%.
                                                                                                               If the concentration is more than 5% but no more than 20%, the pH of the medicine must be 3.5 or greater.