Tinted Mineral Sunscreen for Face

PROCEDURES: (8 Week Study) Visit 1: Potential subjects will report to the Testing Facility and complete an ICF and a Photographic Release Form. Those who complete an ICF will become subjects. Subjects will complete a Medical History Form to determine initial qualification. For 7 days prior to the Test Phase (Day 0) of the trial, subjects will discontinue use of any type of skincare product on their face. Subjects will wash their face two times each day with a non-moisturizing cleanser, provided by the Testing Facility. Subjects will be required to use the provided cleanser exclusively, in both the Conditioning Phase and Test Phase of the trial. A daily diary will be provided to each subject to document each face cleansing application. Visit 2 (Day 0): Subjects will report to the Testing Facility at their scheduled appointment time, without moisturizer or makeup, and will wash their face at the Testing Facility. Subjects’ Conditioning Phase daily diaries will be collected and reviewed for compliance. An Expert Grader will evaluate each subject’s face for evidence of erythema, edema, dryness, and any other anomalies. Subjects presenting a score of moderate (2) or greater for erythema, edema, or dryness will be disqualified. An Expert Grader will also evaluate each subject’s face for hyperpigmentation, dark/age spots, and uneven skin tone. An Expert Grader will evaluate each subject’s face for an area of hyperpigmentation ≥ 8mm in diameter. This area must be in a location that will be visible in a frontal or side view 2D image. The selected area will serve as the test site for all Spectrophotometer measurements. The location of the test site will be measured and recorded. Subjects presenting a score of mild (1) to moderate (2) for hyperpigmentation and with an area of hyperpigmentation ≥ 8mm in diameter will qualify for the trial. An Expert Grader will evaluate each subject’s face for luminosity/brightness. Subjects presenting a score of 2 to 6 will qualify for the trial. All evaluation scores will be recorded on CRFs. Qualified subjects will equilibrate in an environmentally-controlled room for at least 30 minutes, as previously described. After equilibration, the following baseline procedures will be completed by a Bioinstrumentation technician: • 2D Studio Lighting Photography • Spectrophotometer measurements Subjects will be assigned the appropriate shade of test material according to their skin tone. Under clinical supervision, subjects will apply the test material to their bare face according to the Sponsor-supplied use instructions. Subjects will be provided with the pre-weighed test material and a daily diary to document use. Subjects may continue using their regular makeup and facial moisturizing products. Subjects may not use any other facial sunscreens or any skincare products used for hyperpigmentation/dark spots/uneven skin tone/dullness. Subjects may not introduce the use of any new cosmetic, toiletry, or personal care products during the trial. Subjects will also be instructed to follow sun protection guidelines (i.e., wear a hat and sunglasses, stay in the shade when possible, and use the provided sunscreen when engaging in outdoor activities) and to avoid tanning beds for the trial duration. Following test material application, subjects will equilibrate in an environmentally-controlled room for at least 30 minutes. While equilibrating, subjects will complete a questionnaire. The questionnaire will be reviewed for completeness during the visit. After equilibration, the following procedures will be completed by a Bioinstrumentation technician, as previously described: • 2D Studio Lighting Photography Visit 3: (Week 4): Subjects will report to the Testing Facility with their daily diaries and test materials at their scheduled appointment time, without moisturizer or makeup, and will wash their face at the Testing Facility. Daily diaries will be reviewed and test materials will be weighed for compliance and returned to each subject. Subjects’ verbal responses will be recorded for product tolerability. Subjects will be asked if they have experienced any itching, burning, stinging or tightness since their last visit. Subjects will be examined by an Expert Grader, for erythema, edema, dryness, hyperpigmentation, dark/age spots, uneven skin tone, and luminosity/brightness, as previously described. Subjects will equilibrate in an environmentally-controlled room for at least 30 minutes, as previously described. While equilibrating, subjects will complete a questionnaire. The questionnaire will be reviewed for completeness during the visit. After equilibration, the following procedures will be completed by a Bioinstrumentation technician, as previously described: • 2D Studio Lighting Photography • Spectrophotometer measurements Visit 4: (Week 8): Subjects will report to the Testing Facility with their daily diaries and test materials at their scheduled appointment time, without moisturizer or makeup, and will wash their face at the Testing Facility. Daily diaries will be reviewed for completion and test materials will be re-weighed and collected. Subjects’ verbal responses will be recorded for product tolerability. Subject will be asked if they have experienced any itching, burning, stinging or tightness since their last visit. Subjects will be examined by an Expert Grader, for erythema, edema, dryness, hyperpigmentation, dark/age spots, uneven skin tone, and luminosity/brightness, as previously described. Subjects will equilibrate in an environmentally controlled room for at least 30 minutes. While equilibrating, subjects will complete a questionnaire. The questionnaire will be reviewed for completeness during the visit. After equilibration, the following procedures will be completed by a Bioinstrumentation technician, as previously described: • 2D Studio Lighting Photography • Spectrophotometer measurements Subjects will then be dismissed from the trial.