ISO 24443:2021
Cosmetics — Determination of sunscreen UVA photoprotection in vitro
This document specifies an in vitro procedure to characterize the UVA protection of sunscreen products. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner.
In order to determine relevant UVA protection parameters, the method has been created to provide an UV spectral absorbance curve from which a number of calculations and evaluations can be undertaken. These include calculation of the Ultraviolet-A protection factor (UVA-PF) [correlating with in vivo UVA-PF from the persistent pigment darkening (PPD) testing procedure], critical wavelength and UVA absorbance proportionality. These computations are optional and relate to local sunscreen product labelling requirements. This method relies on the use of static in vivo SPF results for scaling the UV absorbance curve.
This document is not applicable to powder products such as pressed powder and loose powder products.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
3.2 Symbols and abbreviated terms
4 Principle
5 Apparatus
5.1 Spectrophotometer specifications
5.2 Calibration of the spectrophotometer
5.3 Calibration of the UV exposure source
5.4 Monitoring of the UV exposure source
5.5 Calibration of the UVA radiometer used to monitor the test sample irradiation
5.6 Substrate/plate
6 Test method
6.1 Outline of the test procedure
6.2 Equipment calibration and validation of test plates
6.3 Absorption measurements through the plate
6.4 Sample application
6.5 Absorbance measurements of the product-treated plate
6.6 Number of determinations
6.7 Determination of initial calculated SPF (SPFin vitro,0), “C” value, initial UVA-PF (UVA‑PF0), and UV exposure dose
6.7.1 Determination of initial in vitro SPF (SPFin vitro,0)
6.7.2 Determination of “C” value
6.7.3 Determination of initial UVA protection factor before UV exposure (UVA-PF0)
6.7.4 Determination of the UV exposure dose
6.8 UV exposure of sample plates
6.9 Calculation of UVA-PF of plates after UV exposure of the sample
6.10 Calculation of critical wavelength of plates after UV exposure of the sample
7 Procedure using the spreadsheet in this document
8 Product reference sunscreen
8.1 Formula S2
8.2 Standard P8
9 Test report
Annex A (normative) Calibration of spectrophotometer and plate transmission test
Annex B (normative) Radiometer calibration to spectroradiometric irradiance procedure
Annex C (normative) Computation values: PPD and erythema action spectra and UVA and UV‑SSR spectral irradiances
Annex D (normative) PMMA substrate plate surface specifications
Annex E (normative) Product reference sunscreen formulations
Annex F (informative) Statistical calculations
Annex G (informative) Definition and examples of valid results/Factor “C”
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
3.2 Symbols and abbreviated terms
4 Principle
5 Apparatus
5.1 Spectrophotometer specifications
5.2 Calibration of the spectrophotometer
5.3 Calibration of the UV exposure source
5.4 Monitoring of the UV exposure source
5.5 Calibration of the UVA radiometer used to monitor the test sample irradiation
5.6 Substrate/plate
6 Test method
6.1 Outline of the test procedure
6.2 Equipment calibration and validation of test plates
6.3 Absorption measurements through the plate
6.4 Sample application
6.5 Absorbance measurements of the product-treated plate
6.6 Number of determinations
6.7 Determination of initial calculated SPF (SPFin vitro,0), “C” value, initial UVA-PF (UVA‑PF0), and UV exposure dose
6.7.1 Determination of initial in vitro SPF (SPFin vitro,0)
6.7.2 Determination of “C” value
6.7.3 Determination of initial UVA protection factor before UV exposure (UVA-PF0)
6.7.4 Determination of the UV exposure dose
6.8 UV exposure of sample plates
6.9 Calculation of UVA-PF of plates after UV exposure of the sample
6.10 Calculation of critical wavelength of plates after UV exposure of the sample
7 Procedure using the spreadsheet in this document
8 Product reference sunscreen
8.1 Formula S2
8.2 Standard P8
9 Test report
Annex A (normative) Calibration of spectrophotometer and plate transmission test
Annex B (normative) Radiometer calibration to spectroradiometric irradiance procedure
Annex C (normative) Computation values: PPD and erythema action spectra and UVA and UV‑SSR spectral irradiances
Annex D (normative) PMMA substrate plate surface specifications
Annex E (normative) Product reference sunscreen formulations
Annex F (informative) Statistical calculations
Annex G (informative) Definition and examples of valid results/Factor “C”
Bibliography