There's a Method to Our Protection

Report: TR-TBL006-25-C-1-R0 · issued 09/25/2025
Method: FDA OTC Monograph M020, in vivo
n: 10 female, phototypes II and III, ages 18–70
Results: Mean static SPF 49.5 · Labeling SPF 46.0
Control validity: standard product 16.1, against limits 12.87–19.73 ✓

Report: STUU525AA1649, issued 10/28/25
Method: FDA OTC M020 2021, in vivo
n: 10 female, phototypes I to III, ages 18-65
Results: average SPF 33.6, can be claimed SPF 30
Control validity: standard product 16.7, against limits 12.87-19.73

Two independent studies were performed via the FDA OTC Monograph M020, in vivo, with n = 10 subjects each. Sunscreen was applied to participants’ backs at the standardized amount of 2 mg/cm² and allowed to dry for 15 minutes. Treated and untreated areas were then exposed to controlled, increasing doses of UV light, and researchers compared the amount of UV needed to produce the first visible signs of sunburn on protected versus unprotected skin.

The first study included 10 females, phototypes II and III, ages 18–70, with average spf 49.5, with label SPF 46.0. The second study included 10 females, phototypes I to III, ages 18-65, with average SPF 33.6, with label SPF 30.

Report: TR-TBL006-25-C-3-R0 · issued 9/22/25
Method: US FDA OTC Monograph M020 in-vitro method.
Results: Critical wavelength: 371.0 nm, requirement >/= 370nm
Results: Broad-spectrum
Conclusion: The critical wavelength was 371.0nm, therefore, can be labeled as “Broad spectrum.”

In an FDA-standard test via the US FDA OTC Monograph M020 in-vitro method, the sunscreen was evenly applied to three PMMA plates, allowed to stabilize in the dark for 15 minutes, and then exposed to a standardized dose of UV radiation. After irradiation, UV transmission and absorbance were measured across wavelengths from 290–400 nm. From these measurements, the critical wavelength was calculated—the wavelength at which 90% of the sunscreen’s total UV absorbance across the 290–400 nm spectrum has been reached. A critical wavelength of at least 370 nm is required by the FDA to demonstrate broad-spectrum protection.

The sunscreen achieved a critical wavelength of 371 nm, meeting the FDA requirement and qualifying it to be labeled “Broad Spectrum.”

Report: TR-TBL006-25-C-2-R0 · issued 10/06/2025
Method: ISO 24442:2022 — IN VIVO determination of sunscreen UVA protection (PPD)
n: 10 female, ITA° 18°–43°, ages 18–70
Results: Average UVAPF 9.4 (95% CI 8.6–10.2, CI% 8.4%) · UVAPF/SPF ratio 0.24
Control validity: P2 = 2.8, S2 = 13.3, both within limits ✓
PA+++. UVAPF 8 to <16 maps to PA+++.

A study performed via the ISO 24442:2022 method, in vivo, with n = 10 subjects. Sunscreen was applied to participants’ backs at the standardized amount of 2 mg/cm², allowed to dry for 15 minutes, and then exposed to controlled doses of increasing UVA light. Researchers compared the amount of UVA needed to produce persistent skin darkening on protected versus unprotected skin to calculate the UVA Protection Factor (UVAPF).

In 10 participants, with skin types ranging from ITA° 18°–43° (roughly Fitzpatrick skin types III and IV), the sunscreen achieved an average UVAPF of 9.4, corresponding to a PA+++ rating.

Report: TR-TBL005-25-C-2-R0 · issued 10/24/25
Method: Based on in vitro methodology described in ISO 24443:2021 for estimating UVA photostability by comparing absorbance spectra before and after controlled irradiation, considering the 320-400 nm range.
Results: At 2h, 4h, and 8h retained 98.2%, 94.7% and 89.9% of of the initial UVAPF value
Conclusion: “retained 89.9% of the initial UVAPF value and was therefore moderately photostable for 8 hours”

In an in vitro photostability study based on ISO 24443:2021 methodology, the sunscreen’s UVA absorbance from 320–400 nm was measured before and after controlled UV irradiation. Researchers compared the UVA Protection Factor (UVAPF) after increasing periods of irradiation with the product’s initial UVAPF to determine how well its UVA protection was maintained with UV exposure.

The sunscreen retained 98.2% of its initial UVAPF after 2 hours, 94.7% after 4 hours, and 89.9% after 8 hours of simulated UV exposure. The study concluded that the sunscreen was moderately photostable for 8 hours.

Report: TR-TBL002-25-A-1-R0 · issued 11/04/2025
Method: Corneometer CM 825, capacitance. Measured on the FOREARM.
n: 32 selected, 26 included, 26 completed
Results: +54.7% at 15 minutes · +25.7% at 8 hours · 100% of participants improved

Report: TR-TBL002-25-A-2-R0 · issued 12/03/2025
Method: Corneometer CM 825. Measured on the FACE.
n: 40 selected, 34 included, 33 completed. Mean age 45 +/- 14. Facial skin type: 45% mixed, 36% normal, 12% dry, 6% greasy. Phototypes II through VI.
Results: +17.0% after 28 days · 100% of participants improved
Stats: Student's t-test, paired, bimodal, 95% confidence
Use: daily, morning, two generous layers to face, neck and ears, ¼ tsp

In a corneometry study, sunscreen was applied to participants’ forearms at a density of 2 mg/cm². Skin moisture levels were measured at baseline and after application using the Corneometer® CM 825 (Courage + Khazaka Electronic, Germany), an instrument that assesses hydration by measuring the skin’s electrical capacitance.

Among 26 participants who completed the study, skin hydration increased by 54.7% after 15 minutes and remained 25.7% higher after 8 hours. All participants showed an improvement in hydration.

In a follow-up 28-day at-home clinical study, participants applied the sunscreen daily to the face, neck, and ears. Facial hydration was measured at baseline and after 28 days using Corneometer® CM 825 (Courage + Khazaka Electronic, Germany), an instrument that assesses hydration by measuring the skin’s electrical capacitance.

Among 33 participants who completed the study, average facial hydration increased by 17.0% after 28 days, with improvement seen in 100% of participants.

Report: TR-TC1063-25-F-72-1-R1 · issued 04/11/2025
Full title: Evaluation of primary dermal irritability, accumulated dermal irritability and dermal sensitization supervised by a dermatologist
N: 115 included, 100 completed.
Panel: 63% women, 37% men · phototypes II 5%, III 62%, IV 33% · normal 12%, mixed 56%, dry 9%, oily 24%
Method: 9 patch applications over 3 weeks, 10-day rest, then sensitization challenge
Results: Irritation index 0.00 · no sensitization · no adverse reactions

In a dermatologist-supervised human repeat insult patch test (HRIPT) skin safety study, the sunscreen was repeatedly applied under patches to assess both irritation and sensitization. Primary irritation was evaluated 48 and 96 hours after the first application. For cumulative irritation testing, patches were applied three times per week on alternating days for three weeks, for a total of nine applications, with the skin evaluated at each visit before reapplication.

After a rest period of at least 10 days, the sunscreen was applied again as a challenge to assess sensitization, with evaluations performed 48 and 72 hours after removal. Participants were evaluated by a dermatologist at the beginning and end of the study and monitored throughout.

Among 100 participants who completed the study, the irritation index was 0.00, with no sensitization or adverse reactions observed. The study supports the claims “dermatologically tested” and “non-irritating.”

Report: TR-TBL002-25-F-1-R0 · issued 12/02/2025
Method: Dermatologist-supervised. Comedones and acne lesions counted under 20x magnification with white fluorescent lighting at forehead, right malar, left malar, chin. Baseline vs. day 28.
n: 32 (32 selected/included/completed) · female, phototypes I–VI, combination to oily skin, ACNE-PRONE (explicit inclusion criterion)
Results: No significant difference in comedones (P=0.8884) · No significant difference in acne (P=0.4368) · no adverse events
Conclusion: "did not induce or enhance the appearance of comedones or acne during the study period, being clinically considered: Non-comedogenic. Non-acnegenic." The panel was selected to be the population most likely to break out.

In a 28-day dermatologist-supervised clinical study, the sunscreen was tested in 32 women with combination-to-oily, acne-prone skin across Fitzpatrick phototypes I–VI. Comedones (open and closed) and acne (inflammatory papules and pustules) were counted at baseline and again after 28 days using 20× magnification under standardized lighting across multiple areas of the face (forehead, right malar region, left malar region, chin).

After 28 days of use, there was no significant increase in either comedones or acne lesions, and no adverse events were reported. The sunscreen was clinically considered non-comedogenic and non-acnegenic.

Report: TR-TBL002-25-F-2-R0 · issued 12/02/2025
n: 34 recruited, 33 completed · female, ages 18–63, phototypes I–VI, all self-declared sensitive skin
Phototype spread: I=1 · II=1 · III=10 · IV=10 · V=8 · VI=3. 21 of 33 were IV–VI. Eleven were V or VI.
Acceptability result: no significant or persistent skin reactions in anyone. Graded "very good cutaneous acceptability on sensitive skin." Zero adverse events.

In a 28-day dermatologist-supervised in-home use study, the sunscreen was tested in 33 women with self-declared sensitive skin across Fitzpatrick phototypes I–VI. Participants used the product at home, recorded any skin reactions daily, and were evaluated by a dermatologist at baseline and after 28 days. Product experience and perceived efficacy were also assessed through questionnaires after immediate use and at days 14 and 28.

No significant or persistent skin reactions or adverse events were observed in any participant. The sunscreen was rated as having “very good cutaneous acceptability on sensitive skin.”