A proposal for simplifying the labelling of sunscreens.
Determination of sun protection factors (SPFs) using the 'gold standard' invivo method (ISO 24444) is known to be associated with appreciable uncertainty because of experimental variability. Consequently, several invitro methods have been evaluated, that show promising accuracy, reproducibility and correlation with the invivo ISO 24444 method. As a way of eliminating the uncertainties associated with both invivo and invitro methods, a proposal is made here to dispense with the concept of the SPF and instead to introduce a binary system for labelling the protection afforded by topical sunscreens. Phototesting can be either invivo or invitro, with invivo phototesting requiring only a single area of sunscreen-protected skin to be irradiated. Alternatively, a validated invitro method could be employed to determine the threshold protection required for assigning products to the appropriate binary category.
- Research Article
1
- 10.26480/wcm.01.2024.20.23
- Sep 25, 2023
- Water Conservation & Management
The concentration of chlorophyll-a in waters is an important indicator in determining the trophic status. In vivo and in vitro methods are the available options for measuring the concentration of chlorophyll-a. Frequently the in vivo and in vitro methods for determining chlorophyll-a concentrations are used separately, so there is less opportunity to compare the measurement results of the two methods. This study aims to compare the results of chlorophyll-a measurements with in vivo and in vitro methods using tropical urban pond water as the media. Water media was collected from two ponds, and then prepared into three different concentrations before the measurements. The results of this study showed that the results of the chlorophyll-a measurement values in one of the two media water sources showed a significant difference (p value = 7.94E-12), while in the other media water sources there was no significant difference. The measurement of overall water sources showed significant differences (p value = 1.00E-07) between the two methods. As a standard method, the in vitro method was proven to be more stable in measuring chlorophyll-a concentrations, but this method has issues related to the need for sample handling and preparation so it requires a longer time to obtain results. The in vivo method can be an alternative method of measuring chlorophyll-a concentrations, especially in situations where monitoring needs to be carried out quickly and intensively.
- Research Article
27
- 10.1111/jocd.12390
- Aug 23, 2017
- Journal of Cosmetic Dermatology
Current invitro SPF screening method for plant oil body (oleosome)-based SPF products possesses significant inconsistency and low reliability in the SPF rating. The primary objective of this study was to evaluate the reliability and reproducibility of spectrophotometrically determined sun protection factor (SPF) from oleosome-based SPF products. The secondary objective was the data comparison of the spectrophotometric measurements against invivo SPF testing to establish a reliable invitro test method as a screening assay. Octyl methoxycinnamate (UVB filter) and avobenzone (UVA filter) were loaded into safflower oil bodies and formulated into oil-in-water emulsion-based finished products. To evaluate the reliability between invivo and spectrophotometric test methods, samples were dispatched to a clinical laboratory, and the reported SPF values were compared with spectrophotometric test results. The observed SPF from the invivo and spectrophotometric test results demonstrated a high correlation for SPF 30 products. Proportional correlation between the two evaluation methods was observed for SPF 15 and 50 products with slightly lesser accuracy with a smaller number of population tested in the clinical studies. A reliable spectrophotometric screening method for oil body-based SPF formulas has been developed using two broadly used organic UV sunscreen actives as a case study. The results demonstrated a high level of reproducibility and reliability compared to the US FDA-guided invivo SPF testing method.
- Research Article
6
- 10.1111/jocd.12941
- Apr 10, 2019
- Journal of Cosmetic Dermatology
The use of sunscreen products has grown considerably in the last few decades because sunscreen products considered as one of the most important ways of skin protection against UV rays by different mechanisms such as reflecting, absorbing, or scattering. Excess expose to UV causes sunburn, early skin aging, and skin cancers. This review aimed to review and compare prominent in vivo sun protection factor (SPF) determination protocols and investigate their approach in test criteria. Finally, this can help skin care specialists to choose the comprehensive SPF determination protocol. Four current SPF determination protocols including ISO 24444, AS/NZS 2604:2012, CEN 2006, and FDA 2011 were selected and compared to each other. Despite the similarity of the test method among these protocols, there are some obvious differences in test criteria which results in a better performance in the individual steps of the test process for each of these methods.
- Research Article
50
- 10.1016/j.jdermsci.2008.06.010
- Aug 28, 2008
- Journal of Dermatological Science
In vitro sunscreen tests are diffusively used to test both the sun protection factor (SPF) and the photo-stability of filters. Spectrophotometric measurements of the absorbance of ultraviolet radiations through a sunscreen applied on a suitable substrate allow a rapid evaluation of its protection factor both at short and long wavelength ultraviolet radiation (UVB and UVA). The objective of this study has been to demonstrate if Teflon can be adopted as substrate both for SPF evaluation and photo-stability tests. Moreover, we have investigated if there is a correspondence between in vitro SPF measurements and values reported by manufacturers on sunscreens. Teflon has been used to perform several photo-stability tests by irradiating the filters with different wavebands and analyzing the combined effect of UV and infrared (IR) light. Similar analyses have been carried out using PMMA Plates, which is the standard substrate for UVA in vitro test. We have demonstrated that it is possible to establish a good correspondence between in vitro SPF and values reported by manufacturers on sunscreens. We have also verified that the in vitro/label SPF correlation curve depends on the quantity of product applied while this does not seem to be true for other parameters like Critical Wavelength and UVA ratio. With regard to photo-stability studies, our results indicate for the first time that IR irradiation may have a role on photo-degradation. The results show that there is a good correlation between the in vitro SPF determined by the present method and the SPF reported by the manufacturer. The compatibility of the results obtained using Teflon and PMMA Plates demonstrates that Teflon can be utilized for both SPF determination and photo-stability tests.
- Research Article
7
- 10.1140/epjst/e2008-00488-2
- Jan 1, 2008
- The European Physical Journal Special Topics
The investigation of the sun protection factor (SPF) and the efficacy of ultraviolet absorber ingredients are extremely important items for the cosmetic industry. The development of new efficient in vitro methodologies for these investigations is an essential condition for the evolution of sunscreens. The most accepted test for assessing the efficacy of sunscreens is the in vivo (in humans) SPF determination, following validated and worldwide adopted methodologies like those regulated by FDA (USA), COLIPA (Europe) and JCIA (Japan). However, due to the high costs and time consumption of in vivo SPF determination, the constant development of in vitro methods able to predict the in vivo SPF is very important. The present study evaluates different experimental methods for in vitro SPF determination – photoacoustic spectroscopy (PAS) and transmission spectroscopy (TS), employing different substrates (PMMA and VitroSkin®) and concentrations (0.8 mg/cm2 and 2 mg/cm2). Results are compared to the labeled SPF. The high correlation between the labeled SPF and the SPF determined by PAS expands the application of this technique in the photobiology field.
- Research Article
2
- 10.1111/ics.13007
- Jul 25, 2024
- International journal of cosmetic science
A sunscreen product is allowed to be marketed if a protection is provided against ultraviolets (UV) including UVA rays and UVB rays expressed by the sun protection factor (SPF). UVB is radiation that is in the region of the ultraviolet spectrum which extends from about 290 to 320 nm in wavelength and that is primarily responsible for sunburn, ageing of the skin, and the development of skin cancer. Thus, since April 2009, the Bureau Interprofessionnel d'Etudes Analytiques (BIPEA) set up a proficiency testing scheme (PTS) for the determination of SPF invivo of sunscreen products according to ISO 24444 standard [Cosmetics - Sun protection test methods - in vivo determination of the sun protection factor (SPF)] to evaluate the analytical performances of laboratories on these analyses. This PTS gathers twenty-six laboratories around the world with one trial a year. For each test, the statistical treatment of the data is performed according to ISO 13528 standard [Statistical methods for use in proficiency testing by interlaboratory comparison]. The assigned and tolerance values are calculated from the participants' data and the performances of the laboratories are evaluated individually and collectively according to ISO 17043 standard [Conformity assessment - General requirements for proficiency testing]. This paper presents the design of the PT program, its development, and an attentive analysis of laboratories results, which highlight the global performances obtained by laboratories on this type of analysis. The evaluation of the results shows, in fact, a relatively constant dispersion of data since the implementation of the PT program (variability between 10% and 50%).
- Research Article
20
- 10.22270/jddt.v8i5-s.1924
- Oct 15, 2018
- Journal of Drug Delivery and Therapeutics
The study involves determination of sun protection factor (SPF) values of some sunscreen formulations for their use in cosmetics. The Sun Protection Factor (SPF) is a very popular instrument in the marketing of sunscreens. Sun protection factor is a laboratory measure of the effectiveness of sunscreen, the higher the SPF, the more protection a sunscreen offers against the ultraviolet radiations causing sunburn. It is often not understood how sunscreens work and where the limitations of the SPF are. A lot of aspects of the SPF are confusing, e.g. the race for higher and higher numbers, the effect on SPF when less sunscreen is applied and if sunscreen should be used at all because they may block the Vitamin D synthesis. The study explains how sunscreens work, how the SPF is determined and where the limitations of the current methods exist. The dynamic view of 'UV radiation applied' and the 'UV dose transmitted' through the sunscreen onto the skin as well as onto a substrate in vitro help in the understanding and are also promising approaches in the in vitro assessment. The study is helpful in selection of some sunscreens formulations used in cosmetics with better safety and high SPF values.
 Keywords: Sun Protection Factor, SPF, Sunscreens
- Research Article
74
- 10.1111/j.1600-0781.2009.00408.x
- Jul 8, 2009
- Photodermatology, Photoimmunology & Photomedicine
To estimate labeled sun protection factor (SPF) for sunscreen, the amount of product applied on volunteers, according to food and drug administration (FDA) and International protocols, is 2 mg/cm(2). However, different studies have shown that consumers actually apply much less product when exposed to the sun. Previous studies have reported contradictory findings in an attempt to correlate the amount applied in relation to SPF. The objective of the present study was to estimate the influence of the quantity of sunscreen applied in the determination of SPF, according to the FDA methodology. Forty volunteers were included in two groups (SPF 15 and 30). The selected sunscreen was then applied in four different quantities (2, 1.5, 1.0 and 0.5 mg/cm(2)). All areas were irradiated with a solar simulator. After 24 h, the minimal erythemal dose (MED) and SPF were determined. In both groups, we observed that the SPF decreased when the amount of sunscreen applied was decreased. The differences between the 2 mg/cm(2) area and the others were significant in both groups (P<0.001). The correlation between specified SPF and applied amount grew exponentially. The protection provided by sunscreen is related to the amount of product applied. It is essential to educate consumers to apply larger amounts of sunscreen for adequate photoprotection.
- Research Article
5
- 10.33759/jrki.v1i2.35
- May 26, 2019
- Jurnal Riset Kefarmasian Indonesia
One way that is done to reduce the negative impact of sunlight is by using sunscreen. Sunscreen can protect the skin by spreading sunlight or absorbing sunlight radiation energy that is about the skin. Phenolic compounds especially flavonoid groups have the potential as a sunscreen because of the chromophore group (single conjugated double bond) capable of absorbing UV light both UV A and UV B, thus reducing the intensity of the skin. Flavonoids have three properties of photoprotektor that is UV absorption, antioxidant properties, and modulate some DNA signaling pathways. The potential of sunscreen can be expressed with Sun Protection Factor (SPF). SPF is designated as UV protection B and is not specifically intended to resist UV A and UV C. The purpose of this research is to know the value of SPF (Sun Protection Factor) of ethyl acetate extract of mango gedong leaves using UV-Vis spectrophotometry. Simplicia gedong mango leaves were extracted using ethyl acetate solvent by reflux. Gedong mango leaf extract identified flavonoid compound using 10% NaOH and H2SO4 (concentrated). Determination of SPF (Sun Protection Factor) value of med gedong leaf extract using UV-Vis spectrophotometry method. The concentration of ethyl acetate extract of mango gedong leaves used was 120 ppm, 240 ppm and 360 ppm. The SPF (Sun Protection Factor) values were analyzed using Mansur method. The result of identification of flavonoid compound showed that the extract of ethyl acetate of mango gedong leaves positively contain flavonoids, while the result of SPF (Sun Protection Factor) extract of ethyl acetate of mango gedong leaves was 5,556; 16,675 and 22,243. The SPF (Sun Protection Factor) extract of 5,556 muddy ethyl acetate leaves including moderate protection type, 16,675 and 22,243 including ultra-protection type when tested using UV-Vis spectrophotometry by Mansur method
- Supplementary Content
- 10.5451/unibas-006161381
- Jan 1, 2013
- edoc (University of Basel)
Summary: Great importance is attributed globally to the protection against UV radiation and the resulting short and/or long-term damaging effects on the human skin. Increasing skin-cancer rates demonstrate the urgency of a broad-spectrum protection of the skin against sunlight and an extensive information and behavioural training for the population. Unlike earlier formulations (between 1985 and 2000), current sunscreen products contain UV filter combinations, with broader protection in the UVB and UVA range of the solar spectrum. The efficacy of the products is expressed by the sun protection factor (SPF) (in vivo determination), which is a measure of the protection against the development of erythema. However, SPF only characterises the protective performance in the UVB range. Determination of SPF is performed exclusively on humans, is time-consuming and expensive and is accompanied by the damaging of the skin of volunteers. Additionally the link between erythema and the development of skin cancer is not completely understood. The UVA protection capacity of a sun protection product can also be determined and the compliance with all requested EU recommandations is indicated with the UVA logo. The UVA protection factor (UVA-PF) can be determined with an accepted in vitro method. There is a worldwide research for additional parameters for characterizing the protective performance of sunscreen products. The objective of the present work was the development of an in vitro test system to characterize the protective performance of formulations already during the development phase. In this context, markers suitable for the characterization of UV-induced damage are evaluated at cellular levels. Different cellular localisations, such as extracellular matrix, cytoplasmic range and nucleic region should be considered in the selection of potential cell damage markers. Cytokines (interleukin 1a and interleukin 8), p38-MAPK, p53, and cyclobutane pyrimidine dimers (CPD) have been analysed experimentally as potential markers. Normal human keratinocytes (HNK) and immortalised HaCaT cells served as models and were exposed to UV radiation. Assay techniques such as ELISA and/or flow cytometry (FACS) were used for read-out evaluation. The kinetics and dose-response relationships were determined for each marker in individual preliminary tests. Two of the five markers tested, delivered no reproducible results. The experiments performed with cytokines as potential cell damage markers were regarded as unsuitable due to the high divergence in the measurement values, and were not followed up. In order to evaluate the selected test systems, different sunscreen products (SPF 5 to 50+) were analyzed. The products were applied to PMMA platelets and the latter were attached to the cell culture dishes. Following UV exposure the markers were quantified. In the case of p38-MAPK, after exposure to a dose of 200 mJ/cm2 UVB and subsequent incubation period of 30 minutes, the maximal activation of p38 was 2.2 ± 0.29. The protective performance of…
- Research Article
4
- 10.22038/ijbms.2007.5276
- Apr 1, 2007
- Iranian Journal of Basic Medical Sciences
Objective To determine and compare the SPF (Sun Protection Factor) and moisturizing effects of the liposomal and conventional lotion formulations containing octyl methoxycinnamte (OMC) as a sunscreen by in vivo methods. Materials and Methods The multilamellar liposomes (MLVs) containing OMC were prepared by fusion method and o/w emulsion was prepared as FDA standard sunscreen method. The SPFs of the formulations were determined by in vivo method according to Australian standard. The exposure area was the back of ten volunteers. Subsites of the backs were exposed to solar simulator as ultraviolet (UV) source. The minimum erythemal dose (MED) for unprotected skin was observed in the next day. The sunscreen was spread (2 mg/cm 2 ) over the area with a finger stall to achieve a uniform film. Each test subsite in a series was exposed to controlled amounts of simulated sunlight by a constant ratio. In the third day, the MEDs of the formulations were observed. The SPF was determined by the ratio between the time required to produce the minimal erythematous reaction by using sunscreen and the time needed to produce the same reaction without using sunscreen. The moisture content of the skin was determined after 30 min, 2, 3, 6 and 10 hours post-application of the formulations containing OMC and also NaCl 3% in eucerin (as a positive control) using Corneometer by measuring electrical capacitance. Results The SPF obtained from our in vivo results for standard Homosalate reference was almost the same as published SPF for this standard. The SPF of the liposomes containing OMC was a little bit more than lotion at the same concentration of OMC. All the tested formulations significantly increased the moisture content of the skin compared to control (without any treatment), in all the tested point times. After 30 minutes of post-application, the skin moisture content resulted from OMC-lotion was significantly more than liposomal-OMC and NaCl 3% in eucerin; however, 10 hours after post-application there were no significant differences in the skin moisture content of these three treatment groups. Conclusion MLV liposomes prepared by fusion method is a good vehicle for OMC as a sunscreen since it provides proper SPF and increase the moisture content of the skin.
- Research Article
2
- 10.22270/ajprd.v11i2.1246
- Apr 25, 2023
- Asian Journal of Pharmaceutical Research and Development
INTRODUCTION: Researchers' interest in creating novel cosmetic formulations has increased due to consumer interest in herbal cosmetics and increased patent activity. The rights of indigenous traditional knowledge and benefit sharing are also safeguarded under IPR.
 OBJECTIVE: To formulate and evaluate herbal sunscreen with determination of Sun Protection Factor (SPF) and anti-oxidant activity. To compare Sun Protection Factor of developed formulation with marketed formulation.
 METHOD: The formulation was developed according to the prepared formula. And multiple tests were done for evaluation i.e., physical observation, spreadability, extrudability, occlusion study, stability study and SPF determination. All the evaluations were found satisfactory. Characterisation of SPF was calculated according to the and UV-Vis Spectrophotometer (LABMAN Scientific instruments Pvt. Ltd.).
 RESULTS:The synergistic activity of all herbal compounds utilized in herbal sunscreen formulations, such as Cucumis sativus, Solanum Lycopersicon, and Aloe barbadensis Efficacy of photoprotection found in following order Marketed formulation > F3 > F2 > F1. For prepared formulation F3 provided better results in comparison to Formulation1 and Formulation 2. Formulation 3 was compared with marketed preparation and it showed good SPF value nearer to market preparation. Overall results were satisfactory. These results reveal that the prepared F3 herbal sunscreen have good SPF and good sun protection activity.
 CONCLUSION: Formulation 3, which consists of three formulations, has been found to be effective as sunscreen in every way. Since few people use sunscreen, there is a need to raise public knowledge of the risks associated with sun exposure as well as the advantages of using sun protection products on a regular basis to lessen these effects. This kind of research will be useful in offering consumers with an all-inclusive solution or product that will protect them from the damaging effects of sunlight.
- Research Article
- 10.1111/phpp.70092
- Apr 12, 2026
- Photodermatology, photoimmunology & photomedicine
The UVB and UVA components of terrestrial solar ultraviolet radiation (UVR) cause acute and chronic damage to skin. These adverse effects can be reduced by sunscreen application. The sun protection factor (SPF) is primarily a measure of UVB protection against erythema and does not quantify protection from UVA, which is the major component of solar UVR. The study aim was to assess UVA protection in relation to labelled SPF and to determine if this met the EU recommendation for a SPF/UVA-PF ratio of ≤ 3, as recommended by the EU. Unlike SPF assessment, there is no universal consensus for the determination and labelling of UVA-PF. Thirty-eight sunscreens with SPF ≥ 50 were selected from Europe, Latin America, Oceania, and Asia. UVA-PF was determined with the ISO 24442:2011 invivo method, which assesses the ability of a sunscreen to inhibit persistent pigment darkening induced by UVA radiation in a laboratory environment. There was variation of UVA-PF ranging from 3.6 to 46.6. Sixty-eight percent (26/38) of sunscreens complied with EU recommendations. Thus, about one third failed these standards, with SPF/UVA-PF ratios varying from 3.1 (borderline failure) to 16.7 (major failure). Failure to comply was observed in several products sold in Europe. The study demonstrates the limitations of many commercial sunscreens to reach EU standards, with significant variations in UVA protection and a lack of relationship between SPF and UVA-PF values. This highlights the importance of improving labelling standards to ensure consumers receive consistent and adequate UVA protection, especially for those with UVA-dependent photodermatoses. ClinicalTrials.gov: NCT06068010.
- Research Article
- 10.1111/iej.70064
- Nov 21, 2025
- International endodontic journal
This study aimed to validate a commonly used invitro methodology of testing the performance of the EALs. For that, clinical data obtained from teeth already scheduled for extraction were used to compare the accuracy and precision of an EAL in determining the position of the apical foramen in both clinical and laboratory settings using micro-CT imaging. In a clinical setting, the working length of 11 canals was established using the Root ZX II apex locator. Subsequently, these teeth were extracted and imaged with and without the file in place using micro-CT technology. Invitro measurements of the working length were then obtained in these same teeth using an alginate model and new micro-CT scans were performed. Datasets were co-registered and the accuracy and precision of both invivo and invitro models were compared by measuring the distance from the file tip to a tangential line crossing the foramen margins, with a tolerance level of ±0.5 mm. Statistical comparisons were performed using Friedman post hoc Related Samples Sign and Bland-Altman tests with a significance level set at 5%. Statistical analysis revealed no significant difference between the accuracy (p = 0.368) and precision (p = 0.761) measurements obtained in both invivo and invitro conditions. Additionally, the Bland-Altman analysis revealed an agreement between invivo and invitro methods (p > 0.05). The invitro methodology using freshly mixed alginate demonstrated consistent accuracy and precision in identifying the position of the apical foramen, when compared to invivo measurements.
- Research Article
- 10.55373/mjchem.v25i2.87
- Mar 9, 2023
- Malaysian Journal of Chemistry
Excessive exposure to ultraviolet (UV) radiation causes various skin problems, including skin cancer.Sunscreen, which contains UV filters, plays an important role in preventing sun damage.Sunscreen protects the skin from UV-induced damage as it absorbs or reflects UV radiation.Nevertheless, continuous exposure to chemical and physical UV filters can result in numerous adverse effects on the skin and the environment.An emphasis has been placed to incorporate natural components such as fruit and vegetable extracts in sunscreen due to their absorption in the UV region, and antioxidant properties.This study aims to evaluate the potential use of Malaysian fruits and vegetables as photoprotective agents by determining their sun protection factor (SPF), total phenolic contents, and antioxidant activity.Five fruit samples, guava, star fruit, sapodilla, dragon fruit, water apple, and five vegetable samples, tomato, brinjal, torch ginger, sweet potato, and onion were analysed for their SPF.The photoprotective activity was recorded using the spectrophotometric method and calculations were done using the Mansur equation.The phenolic content and antioxidant activity of all samples were assessed using the Folin-Ciocalteu method and DPPH radical scavenging assay, respectively.Among all fruit tested, the SPF of guava was found to be the highest, followed by star fruit, sapodilla, dragon fruit, and water apple.While among the vegetables, the onion had the highest SPF followed by torch ginger, brinjal, sweet potato, and tomato, at a concentration of 0.5-1.0mg/ml.A strong correlation was found between SPF with concentration (r = 0.95-0.99,p < 0.05), a weak correlation between SPF with TPC (r = 0.02, p > 0.05), and a moderate correlation between TPC with DPPH (r = 0.46, p > 0.05).The study shows the possibility to incorporate several selected plant extracts into sunscreen in pharmaceutical preparations.