HYDRATION AND SPF TESTING OF LIP BALM FORMULATIONS 9 SPF determination studies. Ten participants were enrolled into study RH01927, all of whom completed the study. All 10 were Caucasian, the majority (8/10) were female, and the mean age was 53.6 years. All participants were classifi ed with a skin type of Fitzpatrick grade II (6/10) or III (4/10) (Table II). Sixteen participants were enrolled into study RH01928 with no study discontinuations. All were Caucasian and the majority (68.8%) were female. The mean age was 57.0 years. All participants were classifi ed with a skin type of Fitzpatrick grade II (68.8%) or III (31.3%) (Table II). Data from three participants were deemed invalid because of a lack of protection at all UV-irradiated subsites following application of test product A. These participants were therefore excluded from the analysis. In study RH02117, 16 participants were enrolled. Three participants discontinued before product testing because of study ineligibility (n = 2) or because the study had recruited suffi cient numbers (n = 1). All participants were Caucasian, the majority (87.5%) were female, and the mean age was 55.1 years. Skin type for all participants was either Fitzpatrick grade II (37.5%) or III (62.5%) (Table II). For test product B, data from four of the par- ticipants were deemed invalid either because of all subsites showing an erythemal re- sponse 20–24 h after irradiation (n = 3) or because of a lack of erythemal response 20–24 h after UV irradiation (n = 1). Similarly, for test product C, data from fi ve of the partici- pants were deemed invalid, either because of all (n = 4) or no (n = 1) subsites showing an erythemal response 20–24 h after irradiation. Thirteen participants were screened and enrolled into study RH02385 to meet the FDA monograph fi nal rule requirements. An additional three participants were enrolled to meet ISO 24444 study requirements, giving a total sample size of 16. Of the 13 who were enrolled for the FDA protocol testing of test products D and E, data from three partici- pants were excluded from the analysis of each test product, either due to a lack of ery- thema MED (n = 2) or invalid data for either the P2 positive control or the test product (n = 1). For the same reasons, data for these three participants were also excluded from the 16 who were enrolled for the ISO 24444 protocol testing of test product D. Of the 16 participants who were enrolled for the ISO 24444 protocol testing of test prod- uct E, data from four were excluded because of the lack of erythema MED (n = 2) invalid Table II Baseline Characteristics of Participants in the Five Studies RH02116, n = 24 RH01927, n = 10 RH01928, n = 16 RH02117, n = 16 RH02385 (FDA), n = 13 RH02385 (ISO 24444), n = 16 Mean age, range (years) 38.2 (24–45) 53.6 (44–66)a 57.0 (43–70)a 55.1 (35–70)a 41.2 (20–59) 42.2 (20–59) Female, n (%) 24 (100) 8 (80.0) 11 (68.8) 14 (87.5) 9 (69.2) 12 (75.0) Fitzpatrick grade, n (%) I NA 0 (0) 0 (0) 0 (0) 4 (30.8) 6 (37.5) II NA 6 (60.0) 11 (68.8) 6 (37.5) 7 (53.8) 8 (50.0) III NA 4 (40.0) 5 (31.3) 10 (62.5) 2 (15.4) 2 (12.5) Mean ITA, NA NR NR NR 50.9 51.6 a Mean age and range calculated based on subjects’ year of birth Fitzpatrick grading: I, burns easily, never tans II, burns easily, tans minimally III, burns moderately, tans moderately (13).

JOURNAL OF COSMETIC SCIENCE 10 data for the test product or P2 positive control (n = 1) and for technical reasons (n = 1). Separate baseline demographics were determined for the FDA fi nal rule cohort and the ISO 24444 cohort. Participants enrolled for the FDA fi nal rule protocol were all white, more than half (69.2%) were female, and the mean age was 41.2 years. Participants had a skin type of Fitzpatrick grade I (30.8%), II (53.8%), or III (15.4%), with a mean ITA of 50.9° (Table II). All participants enrolled for the ISO 24444 protocol were Caucasian, the majority (75.0%) were female, and the mean age was 42.2 years. Participants had a skin type of Fitzpatrick grade I (37.5%), II (50.0%), or III (12.5%), with a mean ITA of 51.6° (Table II). EFFICACY AND EXPLORATORY ENDPOINTS Barrier function and moisturizing abilities study. Dry-skin leg model. Statistically signifi cant changes in TEWL at 1, 3, and 6 h post–lip balm application indicated an improvement in barrier function (decreased water loss) with test product B and all four comparator/ reference products versus untreated dry leg skin (p 0.0005) (Table III). Test product B also showed a statistically signifi cant reduction in TEWL, indicating an improvement in barrier function, versus three of the four comparator lip balms at all three time points (comparators A, B, and D p 0.0001) the fourth comparator (comparator C) showed signifi cantly lower TEWL compared with test product B at all three time points (p 0.0004 Table III). Skicon data indicated a statistically signifi cant improvement in skin hydration (moistur- izing ability) for test product B and three of the four comparator lip balms (A, C, and D) versus untreated dry leg skin (p 0.0001) at all three time-points (Table III). Improve- ment in skin hydration was signifi cantly greater for test product B relative to comparators Table III Study RH02116: Dry-Skin Leg Model Barrier Function, and Skin Hydration Data for Test Lip Balm, Four Comparator Products, and Untreated Skin Time point Test product B Comparator A Comparator B Comparator C Comparator D Untreated skin (control) Means for TEWL measurements (g m-2 h) Baseline 5.72 5.83 5.81 5.69 5.77 5.62 1 h 3.40 4.51 4.31 2.61 4.32 5.13 3 h 3.42 4.44 4.36 2.94 4.29 4.92 6 h 3.30 4.32 4.18 2.79 4.16 4.78 Means for Skicon measurements (μS) Baseline 38.21 36.82 34.97 35.29 35.46 35.23 1 h 129.37 196.44 52.72 150.68 133.08 41.43 3 h 127.93 179.89 51.52 142.81 118.08 44.14 6 h 131.57 159.03 51.23 126.94 103.75 47.93 Means for Corneometer measurements (au) Baseline 12.88 13.56 13.41 12.55 12.89 12.65 1 h 30.99 23.53 16.29 20.33 15.24 14.20 3 h 31.83 24.53 18.04 21.86 16.99 14.60 6 h 31.62 26.89 20.11 25.34 19.77 15.46 μS: micro-siemens.