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The New Sunscreens Among Formulation Strategy, Stability Issues, Changing Norms, Safety and Efficacy Evaluations

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The New Sunscreens Among Formulation Strategy, Stability Issues, Changing Norms, Safety and Efficacy Evaluations cosmetics Article The New Sunscreens among Formulation Strategy, Stability Issues, Changing Norms, Safety and Efficacy Evaluations Nicola Lionetti 1 and Luigi Rigano 2,* 1 Rigano Laboratories S.r.l., 20125 Milano, Italy; [email protected] 2 ISPE, Institute of Skin and Product Evaluation, 20125 Milano, Italy * Correspondence: [email protected] Academic Editors: Marisanna Centini and Cecilia Anselmi Received: 27 March 2017; Accepted: 9 May 2017; Published: 16 May 2017 Abstract: The sun-and-skin interactions have controversial sides. Besides important beneficial effects, we need to take into consideration also some serious harmful results. In particular, these are connected to the portion of the solar spectrum traditionally identified as ultraviolet type A and B. The topical application of sunscreens (and the avoidance of extreme exposure to sun rays) is worldwide recognized as the best strategy to avoid sunburn and oedema. Moreover, such strategy can efficiently prevent the onset of skin cancer. Therefore, the first aim of sunscreen products is to efficiently minimize all damage of sun exposure, while, at the same time, keeping good skin tolerability, avoiding safety problems and developing pleasant sensorial properties. Sunscreens, i.e., substances able to reflect and/or absorb, at a partial or complete extent, UV radiation are the key actors in skin protection. They are used to implement the level of primary photoprotection against UV rays. This means that when they absorb the radiation energy, their molecules pass to an excited state and successively re-emit energy in other forms (vibrational, rotational, infrared radiation) to come back to the ground state. Keywords: Sunburn Protection Factor; formulation; filters stability; nanoparticles 1. Introduction The role the UV rays play in inducing adverse effects at systemic, ocular and skin level is becoming more and more evident. In the past, as the UVB radiation was held responsible for immediate and evident skin damages, such as erythema or sunburns [1] the attention was mainly focused on UVB protection. However, some biological damages caused by UVB radiation on the DNA of keratinocytes and by the longer wavelength UVA radiation on the dermis, are asymptomatic. Their effects tend to accumulate over time and show their mischiefs after many years. The UVB radiation induces carcinogenesis too. After penetrating the dermis, the UVA radiation causes the release of free radicals which progressively damage the nuclear DNA, cell membranes, functional and structural protein of skin cells and causes the onset of elastosis as well as possible cancerous changes. Moreover, the UVA radiation is the main concomitant cause of skin photosensitization and phototoxicity [2]. Considering that the incident radiation spectrum is constituted by approximately 95% of UVA radiation, we can easily work out how important is to arrange an appropriate skin protection strategy also from this thick slice of the solar spectrum, which is particularly dangerous as cannot be screened by either plastic or glass. As regards the UVC rays portion of the spectrum, they are extremely harmful but cannot reach the surface of the earth because of the screening action due to the ozone layer. Cosmetics 2017, 4, 15; doi:10.3390/cosmetics4020015 www.mdpi.com/journal/cosmetics Cosmetics 2017, 4, 15 2 of 11 Cosmetics 2017, 4, 15 2 of 11 The efficientefficient reductionreduction of of all all harmful harmful uncontrolled uncontrolled exposure exposure to ultravioletto ultraviolet radiation radiation effects effects is one is ofone the of currentthe current problems problems of the of cosmetics the cosmetics industry. industry. In some In regionssome regions of the worldof the thatworld could that be could defined be “atdefined high risk”,“at high this risk”, is supported this is supported by the actions by the of ac governmentstions of governments and their publicand their health public policy. health Moreover, policy. theMoreover, formulation the formulation of sunscreen of productssunscreen has products increased has andincreased widened and their widened protection their protection range, while range, the informationwhile the information to consumers to consumers has become has more become complete more andcomplete clear. and clear. The result of this increasing attention lead, in the last years, to the development of precise standards. These These forced the industry to respect manufacturing criteria, for example, of sunglassessunglasses and eyeglasses, hats, clothing (children’s suits), umbrellas,umbrellas, shielding paints for automobile windows and tents. These standards also detail the methodsmethods of measurement the protection factors (UVB and UVA). TheThe AustralianAustralian Cancer Council, non-governmentalnon-governmental organization for for the the prevention prevention of of cancer, cancer, has dedicated many pages of its website to illustrateillustrate a series of tips and tools to prevent harmful exposures [[3].3]. In Australia, the stro strongng insolation due to the latitude of the continent adds to the high solar sensitivity of the inhabitants, mostlymostly light-skinnedlight-skinned forfor theirtheir Anglo-SaxonAnglo-Saxon origin.origin. Also in Europe, a growing interest in sun protection developed quickly. In 2006, the European Commission published thethe RecommendationRecommendation 2006/647/EC2006/647/EC on on protective protective efficacy efficacy of sunscreen products andand related related indications indications of useof use [4]. This[4]. Th publicationis publication was intended was intended to standardize to standardize and simplify, and insimplify, Europe, in the Europe, way how the theway effectiveness how the effectiveness of sun protection of sun products protection is verifiedproducts and is theverified clarity and of the labelclarity of of commercial the label of products. commercial products. According to that Recommendation, the SPF (Sunburn(Sunburn Protection Factor) value must be written on the label and just eight numerical values could be claimed, claimed, as as well well as as the the relevant relevant protection protection level. level. It isis importantimportant toto underline underline that that the the minimum minimum suggested suggested labelled labelled SPF SPF must must be 6be and 6 and the the maximum maximum 50+ (corresponding50+ (corresponding to a to measured a measured SPF SPF value value≥ 60). ≥ 60). Furthermore, Furthermore, the the SPF SPF value value must must befollowed be followed by theby qualitativethe qualitative description description (low, (low, medium, medium, high hi orgh very or very high high protection) protection) (Table (Table1). 1). Table 1. SPF classificationclassification table. ProtectionProtection Level Level SPF SPF Value Value LowLow protection protection 6, 6,10 10 MediumMedium protection protection 15, 15, 20, 20, 25 25 HighHigh protection protection 30, 30, 40 40 VeryVery high high protection protection 50+ 50+ Finally, thethe UVA UVA protection protection value value should should keep keep a precise a precise correlation correlation with with the UVB the protectionUVB protection value mentionedvalue mentioned on the on label. the Thelabel. minimum The minimum UVA protectionUVA protection should should be at least be at 1/3 least of 1/3 the of UVB the (e.g.,UVB a(e.g., SPF 15a SPF product 15 product in the UVBin the range UVB shallrange have shall a have UVA a protection UVA protection factor offactor at least of at 5). least 5). Furthermore, the critical wavelength value must be, at least, equal to 370370 nm.nm. This means the limit wavelength at which the area of thethe sectionsection underunder thethe integratedintegrated optical density curve starting at 290 nm up to 370370 nmnm equalsequals 90%90% ofof thethe integratedintegrated sectionsection drawndrawn betweenbetween 290 nm toto 400400 nm.nm. In other words, the product must be able to absorb enough UV radiation at at longer longer wavelength wavelength (UVA). (UVA). The compliance to both requirementsrequirements isis shownshown onon thethe labellabel byby thethe circledcircled acronymacronym UVAUVA (Figure (Figure1 ):1): Figure 1.1.Symbol Symbol used used for for products products compliant compliant with thewith requirement the requirement of UVA of protection UVA protection and minimum and Criticalminimum Wavelength Critical Wavelength of 370 nm. of 370 nm. Reporting on the label the following warnings for the consumers is also recommended: Reporting on the label the following warnings for the consumers is also recommended: • Do not stay too long in the sun, even while using a sunscreen product. • Keep babies and young children out of direct sunlight. Cosmetics 2017, 4, 15 3 of 11 • Do not stay too long in the sun, even while using a sunscreen product. • Keep babies and young children out of direct sunlight. • Over-exposure to the sun is a serious health threat. • Reducing the quantity of sunscreen product applied will significantly lower the level of protection. • Apply (generously) sunscreen products before sun exposure. • Reapply frequently to maintain protection, and especially after perspiration, swimming or towelling. Based on several studies, the International Agency for Research on Cancer of the World Health Organisation [5] has emphasised the importance of the link between the correct application of sunscreen products and the efficacy of the sun protection factor claimed. In particular, the frequent re-application of sunscreen products is crucial. Moreover,
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