DOCSLIB.ORG

New Technology Provides Cosmetically Elegant Photoprotection Zoe Diana Draelos, MD; Christian Oresajo; Margarita Yatskayer; Angelike Galdi; Isabelle Hansenne

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
New Technology Provides Cosmetically Elegant Photoprotection Zoe Diana Draelos, MD; Christian Oresajo; Margarita Yatskayer; Angelike Galdi; Isabelle Hansenne COSMETIC CONSULTATION New Technology Provides Cosmetically Elegant Photoprotection Zoe Diana Draelos, MD; Christian Oresajo; Margarita Yatskayer; Angelike Galdi; Isabelle Hansenne he primary preventable cause of photoaging is United States, as there is no official rating system for exposure to UVA radiation. This wavelength UVA photoprotection yet. T emitted by the sun is present year round in all Ecamsule absorbs UVA radiation in the range of 320 to latitudes. Currently, the majority of sun-protective prod- 360 nm, but its peak absorbance occurs at 345 nm. It is ucts provide excellent UVB protection with minimal UVA typically combined with other organic sunscreen ingredi- protection. Although UVB protection is important in ents, such as avobenzone and octocrylene. Avobenzone, order to prevent sun damage to the skin from occurring, which is a photounstable photoprotectant, becomes UVA protection is equally important. New developments photostable when combined with octocrylene. These in raw material science have led to the manufacture of ingredients yield a photostable broad-spectrum sunscreen novel ingredients able to provide unprecedented photo- combination. However, the active sunscreen agents are protection COSin the UVA spectrum. DERMonly part of the formulation. Also important in sunscreen One of the most significant developments in cutaneous is the construction of the vehicle to deliver the photo- UVA protection was the discovery of ecamsule (Figure 1), protectants in an aesthetically pleasing manner, enticing also known as Mexoryl SX. Mexoryl SX, which has patients to wear the product. Sunscreens fail to be effec- the International Nomenclature of Cosmetic Ingredients tive if they remain in the bottle. name of terephthalylidene dicamphor sulfonic acid, is In order to evaluate the efficacy and tolerability of a water soluble. It is a benzylidene camphor derivative from moisturizing sunscreen containing ecamsule in combina- the familyDo of photoprotectants thatNot is known for excellent tion withCopy avobenzone and octocrylene, a research study photostability. Mexoryl SX was approved by the US Food was executed with a new FDA-approved daily moisturizer and Drug Administration for use as a sunscreen; however, with a sun protection factor (SPF) of 15. it has not been added to the sunscreen monograph. Ecamsule is a unique photostable UVA sunscreen Method ingredient. When a photon of UVA radiation strikes The 12-week, single-center study enrolled 25 healthy, ecamsule, it undergoes reversible photoisomerization nonpregnant female subjects ranging in age from followed by photoexcitation. The absorbed energy is 35 to 65 years who displayed mild to moderate fine lines, radiated from the skin as heat. This transformation of wrinkles, and hyperpigmentation. All subjects signed an UVA radiation into heat prevents photoaging. However, institutional review board–approved informed consent the ability of ecamsule to protect the skin against UVA form and were asked to use a provided cleanser twice radiation cannot be listed on the packaging in the Dr. Draelos is Consultant and Researcher for the Skin Care Industry and Primary Investigator, Dermatology Consulting O Services, High Point, North Carolina. Mr. Oresajo, Ms. Yatskayer, HO S SO H Ms. Galdi, and Ms. Hansenne are scientists, Research and 3 3 Development, all at L’Oréal Recherche, Clark, New Jersey. O Dr. Draelos is a researcher for L’Oréal USA. Mr. Oresajo, Ms. Yatskayer, Ms. Galdi, and Ms. Hansenne are all employees of L’Oréal USA. Research for this study was provided by an unre- stricted educational grant from L’Oréal USA. Figure 1. The chemical structure of ecamsule. 16 Cosmetic Dermatology® • JANUARY 2008 • VOL. 21 NO. 1 Copyright Cosmetic Dermatology 2010. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher. daily and the SPF 15 daily moisturizer in the morning. roughness (P5.001). Continued improvement was noted Assessments were performed at baseline and weeks 2, 4, at week 4, with statistically significant improvement in 8, and 12. Measurements included investigator ordinal radiance (P,.001), roughness (P,.001), and overall grading of fine lines, wrinkles, radiance, skin roughness, global assessment (P,.001). Week 8 revealed continued skin tone, hyperpigmentation, and global assessment improvement in skin appearance with statistical signifi- at each visit. The ordinal scale was defined as follows: cance in skin radiance (P,.001), roughness (P,.001), 05none, 0.55very minimal, 15minimal, 1.55very mild, scaling (P5.027), and tone (P5.004) and overall global 25mild, 2.55moderate, 35moderately severe, 3.55severe, and 45extremely Baseline Week 2 Week 4 Week 8 Week 12 severe. The investigator also performed an 2.5 objective assessment of erythema, scaling, and acne in addition to asking subjects for 2.0 † their perception of product-induced itch- † ing and stinging. The previously described * † † ordinal rating scale was used. Subject self- 1.5 assessments were also obtained at each visit † † using the ordinal scale in terms of lines, Mean Data 1.0 † † wrinkles, dryness, redness, color, acne, † † peeling, itching, and stinging. Compliance † was determined from diaries completed by 0.5 † the subjects. The study also incorporated noninva- 0 sive assessmentCOS techniques at baseline and DERMRadiance Roughness Global Assessment weeks 2, 4, 8, and 12. Corneometry, the Figure 2. Grading results showing the improvement of skin radiance and rough- measurement of the water contained in ness and global assessment in patients using a moisturizing sunscreen contain- the skin through electrical impedance, was ing ecamsule in combination with avobenzone and octocrylene from baseline to evaluated along with chromameter mea- week 12. Asterisk indicates clinical significance (P≤.05); dagger, changes based on a scale of 0 to 4, where 05none, 0.55very minimal, 15minimal, 1.55very mild, 25mild, surements in order to evaluate skin redness 2.55moderate, 35moderately severe, 3.55severe, and 45extremely severe. and melanin content. Both readings were taken from the medial cheeks in an area Do NotBaseline WeekCopy 2 Week 4 Week 8 Week 12 representative of the entire face. Digital photographs were obtained for documen- 3.0 tation and showed the face at full-frontal view, 45° to the right, and 45° to the left. 2.5 † Results * 2.0 All 25 female subjects who enrolled suc- † cessfully completed the study. No adverse 1.5 † experiences were encountered during the Mean Data study, providing an excellent tolerability 1.0 profile. All of the ordinal data were ana- lyzed utilizing a 2-tailed, unpaired Mann- 0.5 Whitney T test with significance defined at the level of P≤.05. 0 The investigator noted improvement Skin Tone Hyperpigmentation in a variety of different areas both early Figure 3. Grading results showing the improvement of skin tone and hyper- and late in the study (Figures 2 and 3). pigmentation in patients using a moisturizing sunscreen containing ecamsule At the end of week 2, the investigator in combination with avobenzone and octocrylene from baseline to week 12. noted statistically significant improvement Asterisk indicates clinical significance (P≤.05); dagger, changes based on a scale 5 5 5 5 5 in radiance (P5.029), a visual assess- of 0 to 4, where 0 none, 0.5 very minimal, 1 minimal, 1.5 very mild, 2 mild, 2.55moderate, 35moderately severe, 3.55severe, and 45extremely severe. ment of the reflectivity of the skin, and VOL. 21 NO. 1 • JANUARY 2008 • Cosmetic Dermatology® 17 Copyright Cosmetic Dermatology 2010. No part of this publication may be reproduced, stored, or transmitted without the prior written permission of the Publisher. COSMETIC CONSULTATION assessment (P,.001). Finally, by week 12, the investiga- the use of the SPF 15 daily moisturizer. Similarly, there tor noted improvement in radiance (P,.001), roughness was also a gradual trend toward decreased facial ery- (P,.001), scaling (P5.027), tone (P,.001), pigment thema from 16.23 at baseline to 13.99 at week 12. This is (P5.026), and overall global assessment (P,.001). The noteworthy because it indicated the absence of product- investigator data demonstrated that the SPF 15 daily induced inflammation. moisturizer produced immediate improvement in the appearance of the skin that gradually continued. Comment The investigator data were collaborated by the subject One of the biggest challenges dermatologists face is data. The subjects noted a statistically significant light- convincing patients to wear sunscreen on a daily basis. ening of skin color at weeks 4 (P5.015) and 8 (P5.020) There is no doubt that the best treatment for facial pho- as a result of applying the SPF 15 daily moisturizer. toaging is the prevention of further photodamage and the They also reported a statistically significant (P5.015) creation of a UV-free environment for photorepair. The improvement in skin dryness at week 4. No increase only ingredients that can provide this type of protection in acne, peeling, itching, or stinging, was reported by for the face are sunscreens. Older sunscreen formula- the subjects during the use of the product, yielding an tions contained greasy organic photoprotectants that left excellent safety profile. a sticky, heavy film on the face. Their UVA-protective Noninvasive assessments also confirmed the investiga- abilities were limited along with their photostability. New tor and subject impressions of excellent skin moisturiza- sunscreen ingredients, such as
Load more

Recommended publications
  • GAO-18-61, SUNSCREEN: FDA Reviewed Applications For
    United States Government Accountability Office Report to Congressional Committees November 2017 SUNSCREEN FDA Reviewed Applications for Additional Active Ingredients and Determined More Data Needed GAO-18-61 November 2017 SUNSCREEN FDA Reviewed Applications for Additional Active Ingredients and Determined More Data Needed Highlights of GAO-18-61, a report to congressional committees Why GAO Did This Study What GAO Found Using sunscreen as directed with other The Food and Drug Administration (FDA), within the Department of Health and sun protective measures may help Human Services, implemented requirements for reviewing applications for reduce the risk of skin cancer—the sunscreen active ingredients within time frames set by the Sunscreen Innovation most common form of cancer in the Act, which was enacted in November 2014. For example, the agency issued a United States. In the United States, guidance document on safety and effectiveness testing in November 2016. sunscreen is considered an over-the- counter drug, which is a drug available As of August 2017, all applications for sunscreen active ingredients remain to consumers without a prescription. pending after the agency determined more safety and effectiveness data are Some sunscreen active ingredients not needed. By February 2015, FDA completed its initial review of the safety and currently marketed in the United States effectiveness data for each of the eight pending applications, as required by the have been available in products in act. FDA concluded that additional data are needed to determine that the other countries for more than a ingredients are generally recognized as safe and effective (GRASE), which is decade. Companies that manufacture needed so that products using the ingredients can subsequently be marketed in some of these ingredients have sought the United States without FDA’s premarket approval.
    [Show full text]
  • 1. Background and Action Requested
    June 27, 2019 Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Comments Submitted to Docket No. 1978N-0018 (Formerly Docket No. FDA–1978–N– 0038) for “Sunscreen Drug Products for Over-the-Counter Human Use,” Regulatory Information No. 0910-AF43 DSM Nutritional Products LLC (“DSM”) is pleased to provide the following comments in response to the Food and Drug Administration’s (FDA’s) Tentative Final Monograph (“TFM”) for Sunscreen Drug Products Over-the-Counter (OTC) Human Use, published at 84 Fed. Reg. 6204 (February 26, 2019). As a global science-based company active in Nutrition, Health and Sustainable Living, DSM is a world leading supplier of vitamins, feed, food, pharmaceutical, cosmetic, personal care and aroma ingredients. In sunscreens, DSM is a leading world-wide provider of numerous UV filters, including Avobenzone. DSM takes human health and safety very seriously and believes that sunscreens are proven and effective interventions that help provide consumer protection against skin cancers and skin damage caused by the sun’s rays. DSM is committed to proactively supporting the safety and availability of existing and new sunscreen active ingredients that help protect public health. DSM requests that FDA modify its proposed rule taking into consideration the comments provided herein. 1. Background and Action Requested Skin cancer is a significant, and largely preventable, public health concern. Sunscreens have been widely and safely used by the general public for their photoprotective properties, including prevention of photocarcinogenesis and photoaging and management of photodermatoses for more than 40 years. FDA’s Sunscreen Monograph rule has identified the permitted active ingredients (UV-filters) for sunscreens since 1978.
    [Show full text]
  • FDA Proposes Sunscreen Regulation Changes February 2019
    FDA Proposes Sunscreen Regulation Changes February 2019 The U.S. Food and Drug Administration (FDA) regulates sunscreens to ensure they meet safety and eectiveness standards. To improve the quality, safety, and eectiveness of sunscreens, FDA issued a proposed rule that describes updated proposed requirements for sunscreens. Given the recognized public health benets of sunscreen use, Americans should continue to use broad spectrum sunscreen with SPF 15 or higher with other sun protective measures as this important rulemaking eort moves forward. Highlights of FDA’s Proposals Sunscreen active ingredient safety and eectiveness Two ingredients (zinc oxide and titanium dioxide) are proposed to be safe and eective for sunscreen use and two (aminobenzoic acid (PABA) and trolamine salicylate) are 1 proposed as not safe and eective for sunscreen use. FDA proposes that it needs more safety information for the remaining 12 sunscreen ingredients (cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, avobenzone). New proposed sun protection factor Sunscreen dosage forms (SPF) and broad spectrum Sunscreen sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks are requirements 2 proposed as safe and eective. FDA 3 • Raise the maximum proposed labeled SPF proposes that it needs more data for from SPF 50+ to SPF 60+ sunscreen powders. • Require any sunscreen SPF 15 or higher to be broad spectrum • Require for all broad spectrum products SPF 15 and above, as SPF increases, broad spectrum protection increases New proposed label requirements • Include alphabetical listing of active ingredients on the front panel • Require sunscreens with SPF below 15 to include “See Skin Cancer/Skin Aging alert” on the front panel 4 • Require font and placement changes to ensure SPF, broad spectrum, and water resistance statements stand out Sunscreen-insect repellent combination 5 products proposed not safe and eective www.fda.gov.
    [Show full text]
  • WO 2013/036901 A2 14 March 2013 (14.03.2013) P O P C T
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2013/036901 A2 14 March 2013 (14.03.2013) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 8/30 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/US2012/054376 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 10 September 2012 (10.09.2012) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, (26) Publication Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, (30) Priority Data: ZM, ZW. 61/532,701 9 September 201 1 (09.09.201 1) US (84) Designated States (unless otherwise indicated, for every (71) Applicant (for all designated States except US): UNIVER¬ kind of regional protection available): ARIPO (BW, GH, SITY OF FLORIDA RESEARCH FOUNDATION, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, INC.
    [Show full text]
  • Les Filtres UV Dans Les Cosmétiques : Une Présence Obligatoire ?
    UNIVERSITÉ DE NANTES UFR SCIENCES PHARMACEUTIQUES ET BIOLOGIQUES ____________________________________________________________________________ ANNÉE 2015 N° THÈSE pour le DIPLÔME D’ÉTAT DE DOCTEUR EN PHARMACIE par Anouk POCHAT Présentée et soutenue publiquement le 14 décembre 2015 Les filtres UV dans les cosmétiques : une présence obligatoire ? Président : Mme Laurence Coiffard, Professeur des universités, Laboratoire de Pharmacie industrielle et Cosmétologie Membres du jury : Directeur de thèse : Mme Céline Couteau, Maître de conférences, HDR, Laboratoire de Pharmacie industrielle et Cosmétologie Mme Françoise PEIGNE , Maitre de conférences à la retraite Page 1 Remerciements A mon président de jury, Professeur à la faculté des sciences pharmaceutiques de Nantes J’exprime mes profonds remerciements à Mme Coiffard, pour m’avoir fait l’honneur de présider mon jury de thèse. A mon directeur de thèse, Maître de conférences à la faculté de Pharmacie de Nantes Je remercie Mme Couteau pour m’avoir conseillée et guidée tout au long de mon travail. A Madame Françoise PEIGNE, Docteur en Pharmacie, Je remercie Mme Peigné d’avoir accepté d’assister à ma soutenance. A ma mère, Je te remercie de m’avoir soutenue et encouragée tout au long de mes études. A mon conjoint, Je te remercie pour ta patience, ton écoute et ton soutien. A mes frères, Je vous remercie pour vos encouragements Page 2 I.Introduction Une exposition prolongée aux UVA et aux UVB peut avoir de graves conséquences sur la santé comme, par exemple, la survenue de cancers cutanés (Aubin F., 2001). Les filtres UV permettent d’assurer une protection dans les domaines UVA et/ou UVB. On en trouve dans les produits de protection solaire que le public utilise ponctuellement lors des expositions prolongées au soleil.
    [Show full text]
  • OSEQUE ZSOLE DUAL SUN BLOCK- Octinoxate Avobenzone Bisoctrizole Spray SONGHAK CO., LTD
    OSEQUE ZSOLE DUAL SUN BLOCK- octinoxate avobenzone bisoctrizole spray SONGHAK CO., LTD. ---------- Active ingredients: Octyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5%, Avobenzone 2%, Bisoctrizole 0.5% Purpose: Sunscreen Inactive Ingredients: Water, Alcohol Denat, Butylene Glycol, Glycerin, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, Isononyl Isononanoate, Glacier Water, Butyloctyl Salicylate, Xanthan Gum, Decyl Glucoside, Disodium EDTA, Methylparaben, Propylparaben, Fragrance Do not use: on wounds, rashes, dermatitis or damaged skin Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately Stop use: Please stop using this product and contact a dermatologist 1. If allergic reaction or irritation occurs 2. If direct sunlight affects the area as above When using this product: Do not use other than directed Warnings: For external use only. Not to be swallowed. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear Uses: Spray or apply liberally over the face and body 15 minutes prior to sun exposure. Always ensure total coverage of all sun exposed areas. Re-apply every 1-2 hours and always after swimming. For spray type, shake it well before use and spray it evenly at 20cm-30cm apart from face or wherever needed. For spray type - shake it well before use For lotion type - turn a cap to use Storage: Keep in a dry or room temperature area OSEQUE ZSOLE DUAL SUN BLOCK octinoxate avobenzone bisoctrizole spray Product
    [Show full text]
  • Annex VI, Last Update: 02/08/2021
    File creation date: 03/10/2021 Annex VI, Last update: 22/09/2021 LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS Substance identification Conditions Wording of Reference Maximum conditions of Product Type, concentration Update date number Chemical name / INN / XAN Name of Common Ingredients Glossary CAS Number EC Number Other use and body parts in ready for use warnings preparation 2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl CAMPHOR BENZALKONIUM 52793-97-2 258-190-8 6% 15/10/2010 ) anilinium methyl sulphate METHOSULFATE 3 Benzoic acid, 2-hydroxy-, HOMOSALATE 118-56-9 204-260-8 10% 02/08/2021 3,3,5-trimethylcyclohexyl ester / Homosalate 4 2-Hydroxy-4-methoxybenzophenone / BENZOPHENONE-3 131-57-7 205-031-5 6% Reg (EU) Not more than Contains 02/08/2021 Oxybenzone 2017/238 of 10 0,5 % to protect Benzophenone-3 February 2017- product (1) date of formulation application from September 2017 6 2-Phenylbenzimidazole-5-sulphonic acid and its PHENYLBENZIMIDAZOLE SULFONIC 27503-81-7 248-502-0 8%(as acid) 08/03/2011 potassium, sodium and triethanolamine salts / ACID Ensulizole 7 3,3'-(1,4-Phenylenedimethylene) bis TEREPHTHALYLIDENE DICAMPHOR 92761-26-7 / 410-960-6 / - 10%(as acid) 26/10/2010 (7,7-dimethyl-2-oxobicyclo-[2.2.1] SULFONIC ACID 90457-82-2 hept-1-ylmethanesulfonic acid) and its salts / Ecamsule 8 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl) BUTYL 70356-09-1 274-581-6 5% 15/10/2010 propane-1,3-dione / Avobenzone METHOXYDIBENZOYLMETHANE 9 alpha-(2-Oxoborn-3-ylidene)toluene-4-sulphoni BENZYLIDENE CAMPHOR SULFONIC 56039-58-8 - 6%(as acid)
    [Show full text]
  • Should a Toxicological Risk Assessment of Ubiquitous Chemicals Be Done Using Data from Only One Source of Exposure?
    Mini Review Open Acc J of Toxicol Volume 4 Issue 2 - January 2020 Copyright © All rights are reserved by Di Nardo JC DOI: 10.19080/OAJT.2020.04.555633 Should a Toxicological Risk Assessment of Ubiquitous Chemicals Be Done Using Data from Only One Source of Exposure? Di Nardo JC1* and CA Downs2 1Retired Toxicologist, Vesuvius, USA 2Executive Director, Haereticus Environmental Laboratory, Clifford, USA Submission: January 09, 2020; Published: January 23, 2020 *Corresponding author: Di Nardo JC, Retired Toxicologist, Vesuvius, USA Keywords: Toxicological; Chemicals; Dioxybenzone; Octocrylene; Oxybenzone; Sulisobenzone Introduction consumers to believe that there is no further risk associated with the After much discussion and petitioning by several individuals, chemical. non-governmental organizations and scientists alike, the Food & Drug Administration (FDA) re-opened the sunscreen drug monograph Data on February 26, 2019 to review the safety of sunscreen actives In October of 2018 the Food & Drug Administration (FDA) banned considered Generally Recognized as Safe and Effective (GRASE) the chemical benzophenone from use in foods and/or in plastic food since 1978 [1]. After their review, the FDA concluded that the public wraps [3], because it was found to cause cancer in rodents according to a study conducted by the National Institute of Environmental safety of a dozen drug actives currently in use (several of which record “does not” currently contain sufficient data to support the Health Sciences in May 2007 [3]. In June 2012 the state of California are benzophenone based chemicals - avobenzone, dioxybenzone, added benzophenone to their Proposition 65 list recognizing it as octocrylene, oxybenzone and sulisobenzone) and, therefore, are a carcinogen and came to an agreement that a sunscreen product requesting industry to provide additional data (mainly toxicokinetics, should not contain any more that 50 parts per million [4].
    [Show full text]
  • Cutaneous Permeation and Penetration of Sunscreens: Formulation Strategies and in Vitro Methods
    cosmetics Review Cutaneous Permeation and Penetration of Sunscreens: Formulation Strategies and In Vitro Methods Silvia Tampucci * ID , Susi Burgalassi ID , Patrizia Chetoni ID and Daniela Monti ID Department of Pharmacy, University of Pisa, 56126 Pisa, Italy; [email protected] (S.B.); [email protected] (P.C.); [email protected] (D.M.) * Correspondence: [email protected] Received: 1 November 2017; Accepted: 7 December 2017; Published: 25 December 2017 Abstract: Sunscreens are the most common products used for skin protection against the harmful effects of ultraviolet radiation. However, as frequent application is recommended, the use of large amount of sunscreens could reflect in possible systemic absorption and since these preparations are often applied on large skin areas, even low penetration rates can cause a significant amount of sunscreen to enter the body. An ideal sunscreen should have a high substantivity and should neither penetrate the viable epidermis, the dermis and the systemic circulation, nor in hair follicle. The research of methods to assess the degree of penetration of solar filters into the skin is nowadays even more important than in the past, due to the widespread use of nanomaterials and the new discoveries in cosmetic formulation technology. In the present paper, different in vitro studies, published in the last five years, have been reviewed, in order to focus the attention on the different methodological approaches employed to effectively assess the skin permeation and retention of sunscreens. Keywords: sunscreens; formulation; in vitro methods; cutaneous permeation; skin penetration 1. Introduction The detrimental effects of human exposure to ultraviolet (UV) radiation have been widely investigated and can be immediate, as in the case of sunburns, or long-term, causing, in most cases, the formation of oxidizing species responsible of photo-aging, immunosuppression and chronic effects such as photo carcinogenicity [1,2].
    [Show full text]
  • EWG Petitions CDC to Conduct Biomonitoring Studies for Common Sunscreen Chemicals
    EWG Petitions CDC To Conduct Biomonitoring Studies for Common Sunscreen Chemicals May 22, 2019 To: U.S. Department of Health and Human Services Centers for Disease Control and Prevention National Center for Environmental Health Agency for Toxic Substances and Disease Registry 4770 Buford Hwy, NE Atlanta, GA 30341 Patrick Breysse, Ph.D., CIH Environmental Working Group (EWG), a nonprofit research and advocacy organization with headquarters in Washington, D.C., is petitioning the Centers for Disease Control and Prevention to add common sunscreen chemicals to the CDC’s Biomonitoring Program. EWG has been doing research on sunscreen ingredients since 2007, helping to educate the public about the importance of using sunscreens for health protection, as well as providing information about health risks that may be associated with certain ingredients used in sunscreen products. In response to a significant increase in the use of sunscreens in the United States and the associated increased potential for systemic exposure to the ingredients in these products, in February 2019, the Food and Drug Administration proposed a new rule for sunscreen products.1 The proposed rule would require sunscreen active ingredients to be assessed for their propensity to absorb through the skin and overall safety. Recently, the FDA completed tests on the absorbance of four common sunscreen active ingredients: avobenzone, oxybenzone, octocrylene, and ecamsule. As reported in a study published by the Journal of American Medical Association in May 2019,2 application of all four tested sunscreen ingredients resulted in plasma concentrations that exceeded the 0.5 ng/mL threshold proposed by the FDA for waiving systemic carcinogenicity studies as well as developmental and reproductive toxicity studies.
    [Show full text]
  • Sun Protection
    DRUG NEWS Recommending the Best Sun Protection Clinical Pearls: o Recommend a “broad-spectrum” sunscreen – one that covers UVB, UVA1, and UVA2. o Recommend SPF 30-50 o Advise on non-pharmacological sun protection methods o Emphasize proper sunscreen application technique o Emphasize skin protection when taking drugs known to cause photosensitivity. Familiarize yourself with known implicated drugs by referring to appendix 2. Background 1-4 The sun emits 3 types of ultraviolet (UV) radiation: UVC (100-290 nm), UVB (290-320 nm), and UVA (320 -400 nm). UVA rays can be further divided into the shorter UVA2 rays and the longer UVA1 rays. UVC rays, the shortest rays, are completely absorbed by the ozone layer, whereas UVB rays penetrate the epidermis and UVA rays, the longest rays, penetrate into the dermis. The main consequence of UVB irradiation is sunburn, but can also include immunosuppression and skin cancer. Consequences of UVA radiation include: phototoxicity (i.e. involvement in drug-induced sun sensitivity reactions), photo-aging, immunosuppression, and skin cancer. What is SPF? 2,5,6,7 It is easy to be misled by Sun Protection Factors (SPF). SPF is assessed through a standardized test by finding the ratio of the minimal dose of solar radiation that produces perceptible erythema (i.e., minimal erythema dose) on sunscreen-protected skin compared with unprotected skin. Sunburn is caused primarily by UVB rays (and shorter UVA2 rays), and thus SPF indicates mostly UVB protection. However, UVA protection is equally important since it is responsible for photo-aging and cancer. Therefore, it is important to look for the phrase “broad spectrum” when choosing a sunscreen as broad spectrum indicates both UVB and UVA protection.
    [Show full text]
  • Four Common Sunscreen Questions – Spring 2015
    Four common sunscreen questions – Spring 2015 Use this information SPF to help you advise 30 your customers about Use the Sun Protection System sunscreen use. 30 SP F 1. How do sunscreens filter the slip, slop, slap, and wrap sun’s rays? Sunscreens may contain physical or chemical Ethoxyethyl p-methoxycinnamate barriers to screen skin against the sun’s (cinoxate)) ultraviolet radiation (UV radiation). While physical barriers reflect or scatter the UV rays, » Salicylates (Homomenthyl salicylate chemical barriers act by absorbing the UV (homosalate), Ethylhexyl salicylate (octyl radiation before it hits the skin. salicylate/octisalate), Trolamine salicylate General advice is to choose a sunscreen which » Avobenzone (butyl methoxydibenzoylmethane) is broad spectrum, which means it filters both UVA and UVB rays. Those who have sensitive » Ecamsule ((terephthalylidene dicamphor skin should choose a sunscreen labelled sulfonic acid; Mexoryl SX) hypoallergenic or low irritant. » Ensulizole ((phenylbenzimidazole sulfonic Typical chemical absorbers include: acid) » Aminobenzoic acid derivatives (Glyceryl » Bemotrizinol (Tinosorb S) PABA), Padimate O, Roxadimate) » Bisoctrizole (Tinosorb M) » (Dioxybenzone, Benzophenones Physical blockers are titanium dioxide and Oxybenzone, Sulisonbenzone) zinc oxide. When applied they leave a thick » Cinnamates (Octocrylene, Octyl opaque (white) layer on the skin. Microfine or methoxycinnamate (octinoxate), nanoparticles of both are transparent on the skin and reflect UV radiation. 2. Do babies’ need a special sunscreen? » Babies’ skin is very sensitive and can sunburn easily so keep them out of the sun. » Once a baby is moving use the sun protection system. » Patch test an untried sunscreen on the skin 24 hours before applying it widely to check that there is no reaction.
    [Show full text]