12 Hour Lip Product

PROCEDURES: 12 Hour Lip Product Visit 1: Potential subjects will report to the Testing Facility at their scheduled appointment time, without makeup on their face and any products on their lips, and complete an ICF to become subjects. Subjects will complete a Medical History Form and demographics form to determine initial qualification. An Expert Grader will evaluate each subject’s lips for evidence of redness, swelling, dryness, and any abnormalities. Subjects presenting a score of moderate (2) or greater for at least one parameter will be disqualified. An Expert Grader will also evaluate each subject’s lips for fullness. Subjects presenting a score of Mild (2) or less will be disqualified. Qualified subjects will be instructed to return to the next Testing Facility visit without makeup on their face and any products on their lips. Visit 2 (13 hour visit): Subjects will report to the Testing Facility at their scheduled appointment time, without makeup on their face and any products on their lips. Subjects will equilibrate in a temperature controlled room for at least 30 minutes. After equilibration, images of the subject’s face will be captured by a Bioinstrumentation technician. Under clinical supervision, subjects will apply the test material according to Sponsor-supplied use instructions. The clinical technician will ensure that subjects have applied the test material to their lips fully and completely. Subjects will remain sequestered at the Testing Facility for the duration of the trial. Conversation between the subject and clinical technician will be kept to a minimum. No one will be allowed in the temperature-controlled room other than the subjects being evaluated and the clinical technician conducting the needed procedures. Subjects will be instructed to take small bites and use front teeth to minimize lip contact while eating, use a straw for all drinks, and avoid the following: • Touching lips. • Applying any other products or makeup to face and lips. • Having contact with surfaces that can remove the test material from their lips (masks, napkins, etc.). • Messy, greasy foods. Following test material application, images will be captured approximately 1 hour, 8 hours, 10 hours, and 12 hours post-application by a Bioinstrumentation technician, as previously described. Subjects will be dismissed from the trial after the final image capture. _____________________________