UV Shield SPF 50 · Independent in-vivo clinical testing
UV Shield was tested in two human clinical trials at the SUNJIN Clinical Research Center (Seoul, Korea): one for sun protection (SPF, UVB) and one for UVA protection (UVAPF / PA grade). Both followed international ISO methods, were approved by an Institutional Review Board and recorded no skin adverse events. Below are the exact results and methods.
Results at a glance
SPF · UVB protection
SPF 59.1 ± 3.7
95% CI 56.5–61.7
ISO 24444:2019/Amd1:2022
UVAPF · UVA protection
PA++++
UVAPF 19.6 ± 2.5 (95% CI 17.8–21.4)
ISO 24442:2022 · JCIA
Skin adverse events
None observed
in either study
Final reports confirmed on March 31, 2026. Requesting company: OTCM. Research institution: SUNJIN Clinical Research Center, Seoul.
Study 1 — Sun Protection Factor (SPF)
Result
The mean SPF of the tested formula was 59.1 ± 3.7 (expected SPF 50+). The 95% confidence interval (56.5–61.7) was within ±17% of the mean SPF (CI = 4.5%), meeting the ISO statistical criterion.
Standard reference sunscreens (validation)
| Reference | Measured mean SPF | Acceptance limits | Status |
|---|---|---|---|
| P2 | 15.6 ± 2.1 | 13.7 – 18.5 | Accepted |
| P8 | 72.5 ± 0.8 | 43.9 – 82.3 | Accepted |
Individual results (10 subjects)
| Subject | Initial MEDu (J/m²) | Final MEDu (J/m²) | Reference | Reference SPF | Product MEDp (J/m²) | Product SPF |
|---|---|---|---|---|---|---|
| S01 | 190 | 218 | P8 | 72.7 | 12555 | 57.5 |
| S02 | 318 | 318 | P2 | 16.0 | 21022 | 66.1 |
| S03 | 245 | 279 | P2 | 14.1 | 16192 | 58.0 |
| S04 | 279 | 323 | P2 | 13.9 | 18437 | 57.0 |
| S05 | 258 | 296 | P8 | 72.7 | 17054 | 57.6 |
| S06 | 216 | 244 | P8 | 73.8 | 14279 | 58.5 |
| S07 | 340 | 392 | P2 | 18.4 | 22475 | 57.3 |
| S08 | 239 | 279 | P8 | 71.4 | 15802 | 56.6 |
| S09 | 273 | 273 | P8 | 72.6 | 18046 | 66.1 |
| S10 | 249 | 288 | P8 | 72.1 | 16453 | 57.1 |
| Mean ± SD | P2: 15.6 ± 2.1 P8: 72.5 ± 0.8 |
59.1 ± 3.7 |
MEDu = minimal erythemal dose of unprotected skin; MEDp = minimal erythemal dose of product-protected skin. SPF per subject = MEDp ÷ final MEDu.
Participants
- 10 healthy volunteers (7 women, 3 men), aged 19–41 (mean 26.9 ± 7.2); no dropouts
- Mean skin ITA° 44.2° (3 subjects 28–40°, 6 subjects 41–55°, 1 subject ≥56°) — ITA° typing accepted per ISO
Study 2 — UVA Protection Factor (UVAPF / PA)
Result
The mean UVAPF of the tested formula was 19.6 ± 2.5, which corresponds to the highest UVA protection grade, PA++++ (UVAPF ≥ 16). The 95% confidence interval (17.8–21.4) was within ±17% of the mean (CI = 9.0%), meeting the ISO statistical criterion.
Standard reference sunscreens (validation)
| Reference | Measured mean UVAPF | Acceptance limits | Status |
|---|---|---|---|
| S1 | 4.6 ± 0.6 | 3.8 – 5.0 | Accepted |
| S2 | 11.8 ± 1.3 | 10.7 – 14.7 | Accepted |
Individual results (10 subjects)
| Subject | Initial MPPDDu (J/cm²) | Final MPPDDu (J/cm²) | Reference | Reference MPPDDs (J/cm²) | Reference UVAPF | Product MPPDDp (J/cm²) | Product UVAPF |
|---|---|---|---|---|---|---|---|
| S01 | 8.0 | 10.0 | S2 | 127 | 12.7 | 200 | 20.0 |
| S02 | 8.0 | 10.0 | S1 | 44 | 4.4 | 200 | 20.0 |
| S03 | 10.0 | 12.5 | S2 | 159 | 12.7 | 250 | 20.0 |
| S04 | 12.5 | 12.5 | S1 | 69 | 5.5 | 312 | 24.9 |
| S05 | 10.0 | 10.0 | S2 | 127 | 12.7 | 200 | 20.0 |
| S06 | 8.0 | 10.0 | S2 | 102 | 10.2 | 160 | 16.0 |
| S07 | 15.6 | 19.5 | S1 | 86 | 4.4 | 312 | 16.0 |
| S08 | 8.0 | 8.0 | S2 | 102 | 12.7 | 160 | 20.0 |
| S09 | 8.0 | 8.0 | S2 | 81 | 10.1 | 160 | 20.0 |
| S10 | 8.0 | 8.0 | S1 | 35 | 4.3 | 160 | 20.0 |
| Mean ± SD | S1: 4.6 ± 0.6 S2: 11.8 ± 1.3 |
19.6 ± 2.5 |
MPPDD = minimal persistent pigment darkening dose. UVAPF per subject = MPPDDp ÷ final MPPDDu.
UVA protection grade (JCIA)
| UVAPF | PA grade | Protection |
|---|---|---|
| 2 to < 4 | PA+ | Low |
| 4 to < 8 | PA++ | Moderate |
| 8 to < 16 | PA+++ | High |
| ≥ 16 | PA++++ ← UV Shield (19.6) | Very high |
Participants
- 10 healthy volunteers (6 women, 4 men), aged 19–51 (mean 30.9 ± 10.6); no dropouts
- Skin ITA° range 18–43° (mean 33.6°) — ITA° typing accepted per ISO
How the studies were conducted
| SPF study | UVA study | |
|---|---|---|
| Standard | ISO 24444:2019/Amd1:2022 (in vivo SPF), JCIA | ISO 24442:2022 (in vivo UVA protection), JCIA |
| Endpoint | Minimal erythemal dose (MED), assessed 16–24 h after UV exposure | Minimal persistent pigment darkening dose (MPPDD), assessed 2–24 h after UV exposure |
| Light source | Multiport Solar Simulator 601-300W (300 W xenon arc), 290–400 nm | Multiport Solar Simulator 601-300W (300 W xenon arc), 320–400 nm |
| Radiometer | PMA2100 + PMA2108 erythema detector | PMA2100 + PMA2118 UVA detector |
| Application | 2.00 ± 0.05 mg/cm² on a 30 cm² area of the back (6 × 5 cm); spread within 35 ± 15 s; 15–30 min drying before UV exposure | |
| Subjects | Healthy women and men aged 18–60; 10 valid subjects required (max. 20) | |
| Statistical criterion | 95% confidence interval within ±17% of the mean; reference sunscreens within ISO acceptance limits | |
| Environment | Controlled room: 23 ± 3 °C, humidity 50 ± 5%, free from direct sunlight | |
Each subject's back was divided into test sites: unprotected skin (to determine the baseline minimal dose), skin with a standard reference sunscreen and skin with the tested product. Responses were scored visually by observers who did not apply the product or perform the exposure. SPF and UVAPF were calculated per subject and averaged, truncated to one decimal place.
Exclusion criteria
- Pregnant or lactating women
- Use of photo-sensitising medication
- Anti-inflammatory, antibacterial, immunosuppressive, steroid or chronic skin disease medication for more than 4 weeks in the test area
- Systemic dermatological conditions
- History of abnormal sun response
- Sun exposure of the back or participation in a UV study within 8 weeks
- Marks, blemishes or nevi, existing sun damage, excessive hair or skeletal protrusions in the test area
Tested formula
The sample tested was a pale yellow cream (internal name "SJ Sunti-aging Suncream", management numbers SCRC_25_SJ0001_0306_P1 and SCRC_25_SJ0001_0307_P1). Main ingredients as reported in the studies:
| Ingredient | Content |
|---|---|
| Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine | 2.00% |
| Diethylamino Hydroxybenzoyl Hexyl Benzoate | 3.00% |
| Ethylhexyl Triazone | 2.50% |
| Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (50%) · Decyl Glucoside · Glycerin · Xanthan Gum · Water | 4.00% (2.00% as Methylene Bis-Benzotriazolyl Tetramethylbutylphenol) |
Safety, ethics and quality assurance
- Both studies were approved by the SUNJIN Beauty Science Co. Ltd. Institutional Review Board (SCRC IRB) on February 21, 2025 (full board review).
- Conducted in accordance with the Helsinki Declaration, Good Clinical Practice (GCP), Korea's Bioethics and Safety Act, JCIA guidelines and the center's SOPs.
- All participants gave written informed consent; personal data was kept confidential.
- Independent quality assurance review of the research plan, IRB approval, study progress, data, draft report and final report — all approved.
- The tested product was manufactured using only raw materials approved for cosmetics, within permitted limits.
- No skin adverse events were observed during any stage of either study.
Research institution
SUNJIN Clinical Research Center
16F, 143 Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea
Principal investigator & center director
Keunhyung Park, Ph.D.
Reliability guarantee officer
Kyounghee Shin, Ph.D.
The center is a member of the Korean Association of Human Skin Research Centers.
Source: SUNJIN Clinical Research Center reports SCRC_25_SJ0001_0306_EnR (SPF) and SCRC_25_SJ0001_0307_EnR (UVAPF), version 3.0, final report date March 31, 2026. Results apply to the formula tested and reflect laboratory conditions; actual protection depends on correct and sufficient application.