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88 SUN CARE


TABLE 1A: IN VITRO (24443) AND IN VIVO SPF SUMMARY FOR FORMULATION 1 In vivo


Testing Lab


Testing Lab 1


Testing Lab 2


Testing Lab 3


Testing Lab 4


In vivo Method FDA 2021


FDA 2021


ISO 24444:2019 ISO 24444:2019 ISO 24444:2019


ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 FDA 2021 FDA 2021 FDA 2021


Average SPF


Standard deviation Margin of error


In vitro


SPF result 52.2


66.1


50.0 52.2 50.0


44.6 50.0 44.6 44.6 58.0 67.0 67.0 53.9 8.64 5.49


SPF result 24.4


23.4 23.4


23.4 In vitro Method


ISO 24443:2021 ISO 24443:2021 ISO 24443:2021


ISO 24443:2021


Testing Lab


Testing Lab 5


TABLE 1B: IN VITRO (24443) AND IN VIVO SPF SUMMARY FOR FORMULATION 1 In vivo


Testing Lab


Testing Lab 1


Testing Lab 2


Testing Lab 3


Testing Lab 4


23.7 Average SPF


0.50 Standard deviation 0.80 Margin of error


even approved for SPF claims in some regions, such as Thailand. However, these methods were also initially


developed for formulations containing organic UV filters. The optimization and validation on mineral-only sunscreen have not been adequately explored to date. Significant deviations between the in vivo standard indicate a gap in reliability of results if adopted.


The double plate method (DPM): a new approach to in vitro SPF testing To address the aforementioned shortcomings of current in vitro SPF tests, the ISO 23675 standard introduces the Double Plate Method (DPM). This method involves applying sunscreen between two PMMA plates with different surface textures: ■ A sandblasted plate, which replicates the rough texture of human skin better ■ A moulded plate, which mimics the natural undulations of the epidermis This dual-plate configuration aims


to improve the accuracy of in vitro SPF measurements by better simulating how sunscreen interacts with human skin. Spectrophotometric techniques are then used to measure UV radiation passing through the film.5


While early results indicate better


Testing Lab


Testing Lab 1


Testing Lab 2


Testing Lab 3


In vivo Method FDA 2021


FDA 2021


ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 FDA 2021 FDA 2021 FDA 2021 FDA 2021


Average SPF


Standard deviation Margin of error


In vitro


23.4 23.4 23.4


SPF result 69.0


43.5 44.6 44.6 39.9 44.6 44.6 50.0 50.0 57.5 57.5 49.6 8.56 5.75


SPF result 24.4


In vivo Method FDA 2021


FDA 2021


ISO 24444:2019 ISO 24444:2019 ISO 24444:2019


ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 FDA 2021 FDA 2021 FDA 2021


Average SPF


Standard deviation Margin of error


reproducibility with most organic, hybrid, and certain mineral formulations,7


variability and provides a more consistent alternative compared to older in vitro testing methods. One of the primary challenges in in vitro


SPF testing for ZnO-based sunscreens is the difference in application thickness. In vivo SPF tests require 2 mg/cm2


vitro methods (both 24443 and DPM method) typically use only 1.2–1.3 mg/cm2


of product, whereas in .1


Due to the higher density and physical


characteristics of ZnO formulations, the resulting sunscreen film on PMMA plates is often thinner compared to the actual spreadability on human skin, leading to an underestimation of SPF values.1


This key


concern will drive the industry's efforts to refine and tailor SPF measurement methods for mineral sunscreens.


Investigating ZnO-based sunscreen formulations This study examines two water-in-oil (W/O) ZnO-based sunscreen formulations, each containing 24.5% ZnO without any SPF boosters. The ZnO concentration was strategically set close to the regulatory


TABLE 2A: IN VITRO (24443) AND IN VIVO SPF SUMMARY FOR FORMULATION 2 In vivo


In vitro Method


ISO 24443:2021 ISO 24443:2021 ISO 24443:2021 ISO 24443:2021


Testing Lab


Testing Lab 4


Testing Lab


Testing Lab 1


Testing Lab 2


Testing Lab 3


23.7 Average SPF


0.43 Standard deviation 0.54 Margin of error


PERSONAL CARE November 2025


In vivo Method FDA 2021


FDA 2021


ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 ISO 24444:2019 FDA 2021 FDA 2021 FDA 2021 FDA 2021


Average SPF


Standard deviation Margin of error


the DPM method


still tends to underestimate SPF values for high- ZnO formulations.1


However, its design reduces In vitro


SPF result 52.2


66.1


50.0 52.2 50.0


44.6 50.0 44.6 44.6 58.0 67.0 67.0 53.9 8.27 5.25


SPF result 11.8


11.9 11.9


In vitro Method


ISO 23675:2024 ISO 23675:2024


Testing Lab


ISO 23675:2024 Testing Lab 6


11.9


Average SPF


0.05 Standard deviation 0.80 Margin of error


maximum, allowing a small margin for analytical deviations. ■ Formulation 1: Uncoated ZnO dispersion G-Block DZ 370 CCT ■ Formulation 2: Triethoxycaprylylsilane- coated ZnO dispersion (S-Block CocoDerm) Both ZnO dispersions are stable, anhydrous


systems with a three-year shelf life, ensuring even particle distribution to optimize UV protection efficacy. Additionally, both formulations are designed to achieve close to 100% naturality (>99.5%) in alignment with current market trends. While the emulsifier and stabilizers remain the same, some adjustments were made to ensure formula stability. The samples have successfully undergone three freeze/thaw cycles and an accelerated ageing stability test at 50°C for two months. A W/O emulsion system was selected to


enhance ZnO film formation on the skin, as ZnO disperses evenly in the continuous phase, maximizing UV protection performance. The formulations were carefully designed to provide good spreadability on the skin, which is a critical factor for in vivo SPF testing. Spreadability directly influences in vivo SPF


values, as formulations with poor spreadability lead to uneven film formation on the skin, resulting in significantly lower SPF values, even


TABLE 2B: IN VITRO (DPM) AND IN VIVO SPF SUMMARY FOR FORMULATION 2 In vivo


In vitro


SPF result 69.0


43.5 44.6 44.6 39.9 44.6 44.6 50.0 50.0 57.5 57.5 49.6 8.56 5.75


SPF result 16.2


16.6 17.2


In vitro Method


ISO 23675:2024 ISO 23675:2024 ISO 23675:2024


Testing Lab


Testing Lab 5


16.7


Average SPF


0.50 Standard deviation 1.25 Margin of error


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