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IMS Inc. In-Vitro SPF Test Results
Date: | 10/8/2024 |
Client: | RUSSELL JESSUP |
Lot Number/Sample Code: | OGS-2409 |
IMS Sample Designation: | 24-168 |
Method: | IMS Protocol |
Substrate: | VITRO-SKIN ® |
Product Application: | 2mg/cm2 |
Instrument | Labsphere UV-1000 Ultraviolet Transmittance Analyzer |
Sunscreen Protection Factor: | STDEV: 35.0 +/- 3.5 |
Wavelength | ABS | MPF |
290 | 1.15 | 14.1 |
295 | 1.40 | 25.3 |
300 | 1.59 | 38.6 |
305 | 1.58 | 37.8 |
310 | 1.54 | 34.3 |
315 | 1.60 | 39.7 |
320 | 1.59 | 39.0 |
325 | 1.58 | 38.4 |
330 | 1.55 | 35.8 |
335 | 1.61 | 40.6 |
340 | 1.64 | 43.6 |
345 | 1.61 | 40.3 |
350 | 1.58 | 37.7 |
355 | 1.61 | 40.6 |
360 | 1.64 | 43.7 |
365 | 1.66 | 45.5 |
370 | 1.68 | 47.4 |
375 | 1.67 | 46.5 |
380 | 1.35 | 22.4 |
385 | 0.96 | 9.1 |
390 | 0.79 | 6.1 |
395 | 0.72 | 5.3 |
400 | 0.69 | 4.9 |
FLORIDA SUNCARE TESTING, INC.
FDA 2021 Static SPF
TABLE 1
Study Number: | 24-2310 |
Sponsor: | The Body Botanical |
Formula No: | 4.00 |
Lot Number: | OGS-2409 |
Sample Description: | OGS Sunscreen |
Report Date: | December 10, 2024 |
Panel | Panel Demographics | ||
Total Enrolled | 11 | Skin Type I | 3 |
Total Completed | 11 | SkinType II | 6 |
TF Static SPF | 1 | Skin Type III | 2 |
TF WR | 0 | Male | 6 |
Female | 5 |
Results Summary | Standard | Static | WR |
Average SPF: | 17.77 | 35.09 | N/A |
STD DEVIATION: | 1.27 | 2.80 | N/A |
A=ts / sq root n | 0.73 | 1.62 | N/A |
X-A | 17.04 | 33.46 | N/A |
Label SPF | 17 | 33 | N/A |
Exposure | Subject | App | Exp | Read | Subject | Sex | Age | Skin Type | MEDu | 1902AE FDA Std. | 24-2310 Static | 24-2310 WR | 1902AE FDA Std Static SPF | 24-2310 Static SPF | 24-2310 WR |
Date | N° | by | by | by | ID No. | M/F | Age | I/II/III | J/m² | J/m² | J/m² | J/m² | |||
11/18/2024 | 1 | AM | DK | MR | 7147 | F | 59 | II | 79.33 | 1487 | 3147 | N/A | 18.75 | 39.68 | N/A |
11/18/2024 | 3 | AM | AM | MR | 7100 | F | 70 | I | 68.46 | 1190 | 2518 | N/A | 18.75 | 39.68 | N/A |
11/19/2024 | 3 | AM | AM | MR | 7161 | M | 34 | III | 79.16 | 1616 | 5702 | N/A | 16.30 | 34.50 | N/A |
11/19/2024 | 4 | AM | AM | MR | 7073 | F | 39 | II | 79.33 | 1487 | 2737 | N/A | 18.75 | 34.50 | N/A |
12/9/2024 | 5 | AM | SP | MR | 7113 | M | 54 | I | 63.46 | 1034 | 2189 | N/A | 16.30 | 34.50 | N/A |
12/9/2024 | 6 | AM | SP | MR | 2959 | F | 40 | II | 79.33 | 1487 | 2737 | N/A | 18.75 | 34.50 | N/A |
12/9/2024 | 7 | AM | AM | MR | 7033 | M | 55 | III | 99.16 | 1616 | 2249 | N/A | 16.30* | 22.68 TF | N/A |
12/9/2024 | 8 | AM | AM | MR | 7008 | M | 76 | II | 79.33 | 1293 | 2737 | N/A | 16.30 | 34.50 | N/A |
12/9/2024 | 9 | AM | AM | MR | 7172 | F | 43 | I | 63.46 | 1190 | 2189 | N/A | 18.75 | 34.50 | N/A |
12/9/2024 | 10 | AM | AM | MR | 7141 | M | 43 | II | 79.33 | 1487 | 2380 | N/A | 18.75 | 30.00 | N/A |
12/9/2024 | 11 | AM | DK | MR | 2659 | M | 60 | II | 79.33 | 1293 | 2737 | N/A | 16.30 | 34.50 | N/A |
TF indicates rejection for the sponsor sample test result because all exposed subsites had an erythemal response.
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