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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. -
Chemical UVR Absorbers
Chemical UVR Absorbers The names given in bold and used Diisopropyl methyl cinnamate Glyceryl ethyihexanoate dimethoxy- throughout this handbook are those of Empirical formula: cinnamate the International Nomenclature of C 6H22O2 Chemical names. Cosmetic Ingredients. Glyceryl octanoate dimethoxycinnamate; Chemical names: 2-propenoic acid, 3-(4-methoxyphenyl)-, 2-Propenoic acid, 3-12,4bis(1 diester with 1 ,3-dihydroxy-2-(2-ethyl-1 - methylethyphenyl-methyl ester; 2,5- oxohexyl)oxypropane diisopropyl methyl cinnamate _ lsoamyl-para-methoxycinnamate Ethyihexyl methoxycinnamate Empirical formula: Empirical formula: C151-12003 C 8H26O3 Chemical names: Cinnamates Chemical names: Amyl4-methoxycinnamate; isopentyl-4- 2-Ethylhexyl-4-methoxycin nam ate; methoxycinnamate; isopenlyl-para- Cinoxate 2-ethyl-hexyl-para-methoxycinnamate; methoxy-cinnamate; 3-(4-methoxyphenyl)- Empirical formula: para-methoxycinnamic acid, 2-ethylhexyl 2-propenoic acid, isopentyl ester Ci4HieO4 ester; 3-(4-methoxyphenyl)-2-propenoic acid, 2-ethylhexyl ester; octinoxate; octyl Trade names: Chemical names: methoxycinnamate; 2-propenoic acid, 3- Neo Heliopan type E 1000; Solarum AMC 2- Ethoxyothyl-para-methoxyci n nam ate; (4-methoxyphenyl)-2-ethylhexyl ester 2-propenoic acid, 3-(4-methoxyphery- para-A minobenzoic acids (PA BAs) 2-ethoxyethyl ester; 2-ethoxyethyl-4- Trade names: methoxycinnamate AEC Octyl Methoxycinnamate; Escalol Amyl dimethyl FABA 557; Eusolex 2292; Heliosol 3; Empirical formula: Trade names: Jeescreen OMC; Katoscreen OMC; Nec C14H21 NO2 Giv Tan F; Phiasol -
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. -
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) -
Determination Par Methode in Vitro De L'efficacite De
P a g e | 1 UNIVERSITE DE NANTES FACULTE DE PHARMACIE DETERMINATION PAR METHODE IN VITRO DE L’EFFICACITE DE PRODUITS SOLAIRES FORMULES AVEC DES FILTRES INORGANIQUES ET/OU ORGANIQUES THESE DE DOCTORAT Ecole Doctorale : VENAM Discipline : Pharmacie galénique Spécialité : Cosmétologie présentée et soutenue publiquement par Soumia EL BOURY ALAMI le 16 juin 2011, devant le Jury cidessous Président : Rapporteurs : Mme MarieChristine ANDRY, Professeur M. Philippe PICCERELLE, Professeur Directeur de Thèse : Mme Laurence COIFFARD, Professeur CoDirecteur : Mme Céline COUTEAU, Maître de Conférences (HDR) P a g e | 2 Introduction Le soleil, indispensable à la vie, est connu depuis longtemps pour ses effets bénéfiques (synthèse de vitamine D, bronzage, effet positif sur le moral). Peu à peu, une prise de conscience s’est opérée permettant de relativiser les bienfaits d’expositions solaires prolongées. Les UVB ont été les premiers à être incriminés dans la survenue de cancers cutanés. La recherche de filtres efficaces dans le domaine UVB a donc vu le jour dans les années 1920 avec en particulier la synthèse de l’acide para-aminobenzoïque. Beaucoup plus récemment, on s’est intéressé à l’implication des UVA et il est maintenant bien établi que ces derniers ont leur part dans la carcinogenèse cutanée et dans le vieillissement photo-induit. Les conséquences de la surexposition solaire de beaucoup de personnes relèvent d’une politique de santé publique et il est devenu indispensable de mener des campagnes de prévention et d’avoir à disposition des consommateurs des produits efficaces tant dans le domaine UVA que dans le domaine UVB. En France, l’AFSSaPS a émis un certain nombre de recommandations visant à atteindre ce but. -
How to Overcome the New Challenges in Sun Care
Thannhausen, Germany, July 31, 2020 Thannhausen, Germany, | Volume 146 Volume | 7+8/20 home care 60 Years Sinner Circle: The Future powered by of Washing and Cleaning 7/8 2020 english How to Overcome the New Challenges skin care Positive Impact of Emulsifiers sun care in Sun Care on End-user Skin Benefits How to Overcome the New Challenges in Sun Care Natural-based 360° Approach for Optimized Formulations Sunscreen Diversity – more Options for Ingredients oral care How Polyurethane Film Formers Can Help A Natural Way to Treat Tooth Sensitivity Reduce the Impact on the Environment M. Sohn, S. Krus, M. Schnyder, S. Acker, M. Petersen-Thiery, S. Pawlowski, B. Herzog SOFW Journal 7+8/20 | Volume 146 | Thannhausen, Germany, July 31, 2020 personalpersonal care care | sun care From the UV filters under scrutiny, the widely used UVB fil- ters Ethylhexyl Methoxycinnamate (EHMC) and Octocrylene (OCR) are heavily discussed due to rising concerns regarding their safety profile for humans and for the environment. In Europe, legally approved UV filters are additionally assessed by the European Chemical Agency (ECHA) within the Regis- tration, Evaluation, Authorization, and Restriction of Chemi- cals (REACh) process, like all other industrial chemicals. Also, in the USA, the Food and Drug Administration (FDA) issued a proposed rule to put into effect a final monograph for over- the-counter sunscreen drug products [2]. In its proposal the © BASF’s Care Creations® FDA describes the conditions under which a sunscreen active is Generally Recognized as Safe and Effective (GRASE) and highlights the safety data gaps and additional required data for each already approved UV filter to be included in catego- How to Overcome the ry I, UV filters with a positive GRASE. -
Patch Test Products and Reference Manual 2015
PATCH TEST PRODUCTS & REFERENCE MANUAL MANUAL REFERENCE & PRODUCTS TEST PATCH 4 World Leader in Patch Testing 2015 CHEMOTECHNIQUE DIAGNOSTICS CHEMOTECHNIQUE PATCH TEST PRODUCTS & REFERENCE MANUAL 2015 MODEMGATAN 9 | SE-235 39 VELLINGE |SWEDEN PHONE +46 40 466 077 | FAX +46 40 466 700 WWW.CHEMOTECHNIQUE.SE [email protected] | [email protected] ...for the diagnosis of contact allergy 2015 The complete range of products for Patch Testing A1 Foreword by Bo Niklasson, CEO First of all I would like to thank all our faithful customers for your support during the past year and also welcome our new distributors that have been appointed during the year. Chemotechnique Diagnostic’s 34 years of continuous growth and development has been the result of our belief in building strong and long term business relationships with our global network of distributors, combined with the ongoing support and contributions of our product-user base of physicians. Our commitment is to continue serving dermatology in future years... maintaining our leadership position. During the past year we have invested in new state of the art equipment in both the analytical and production sector and developed a closed loop system in the production of haptens. When looking at our website you will note that we have made it possible also for patients to freely access our database of extensive information regarding the haptens and being able to print information sheets. We have also changed the site to be adapted to mobile platforms such as mobile phones, iPads and similar devices. There will as always be additions and amendments in our range and these are found at the end of the Patch Test Products & Reference Manual. -
ERMA200782 ERMA200782 CPGS Track-Changes FINAL
Hazardous Substances and New Organisms Act 1996 Cosmetic Products Group Standard 20061 Pursuant to section 96B of the Hazardous Substances and New Organisms Act 1996 (the Act), the Environmental Risk Management Authority, on its own initiative, issues this Group Standard. Contents 1 Title .......................................................................... 1 2 Commencement ........................................................ 2 3 Interpretation ............................................................ 2 4 Scope of Group Standard ......................................... 2 5 Conditions of Group Standard .................................. 4 SCHEDULE 1 CONDITIONS OF GROUP STANDARD 5 Part 1 Information Requirements ............................................ 5 Part 2 Site and Storage .......................................................... 13 Part 3 Approved Handler ....................................................... 15 Part 4 Packaging .................................................................... 17 Part 5 Equipment ................................................................... 19 Part 6 Transportation ............................................................. 21 Part 7 Disposal....................................................................... 22 Part 8 Exposure Limits .......................................................... 25 Part 9 Notification to the Authority ....................................... 26 Part 10 Other Matters .............................................................. 26 SCHEDULE -
Draft Consolidated Cosmetic Products Group Standard 2006 (As
Hazardous Substances and New Organisms Act 1996 Cosmetic Products Group Standard 20061 Pursuant to section 96B of the Hazardous Substances and New Organisms Act 1996 (the Act), the Environmental Risk Management Authority, on its own initiative, issues this Group Standard. Contents 1 Title .......................................................................... 1 2 Commencement ........................................................ 2 3 Interpretation ............................................................ 2 4 Scope of Group Standard ......................................... 2 5 Conditions of Group Standard .................................. 3 SCHEDULE 1 CONDITIONS OF GROUP STANDARD 4 Part 1 Information Requirements ............................................ 4 Part 2 Site and Storage .......................................................... 10 Part 3 Approved Handler ....................................................... 12 Part 4 Packaging .................................................................... 14 Part 5 Equipment ................................................................... 16 Part 6 Transportation ............................................................. 18 Part 7 Disposal....................................................................... 19 Part 8 Exposure Limits .......................................................... 22 Part 9 Notification to the Authority ....................................... 23 Part 10 Other Matters .............................................................. 23 SCHEDULE -
Sunscreens: Is Looking at Sun Protection Factor Enough?
REVIEW ARTICLES Sunscreens: Is Looking at Sun Protection Factor Enough? Dr. T. Y. Ho Social Hygiene Service (Dermatology), Department of Health, Hong Kong ABSTRACT As mounting evidence points to the photocarcinogenicity and the photoaging potential of chronic ultraviolet A (UVA) exposure, broad-spectrum sunscreens that are effective against both ultraviolet B (UVB) and UVA radiation are obviously preferred. Older chemical filters are not effective against the longer UVA. Several chemical filters have been developed recently to provide invisible protection for the UVA spectrum. The sun protection factor (SPF) can only indicate the level of protection against UVB, but not UVA. There is not yet any widely accepted method to measure UVA protection. Keywords: Review, sunscreen, ultraviolet A INTRODUCTION unacceptable. However, several organic UVA filters have been developed recently which aim to provide The sun protection factor (SPF) has widely been invisible protection against the whole UVA spectrum. used to evaluate the protective value of sunscreens. However, SPF only reflects the effectiveness of the This review will examine the evidence for the sunscreen to protect against acute sunburn which is harmful potential of UVA, discuss the safety issues mainly due to ultraviolet B (UVB) radiation. The concerning sunscreen use and the problems with UVA deleterious effects of UVB are well known and UVB protection indicators, look at the UVA protective agents was believed in the past to be the spectrum responsible available commercially and advise on the choice and for the damages arising from ultraviolet radiation the use of sunscreen products. (UVR). However, there has been increasing evidence pointing to the photocarcinogenicity and the photoaging potential of ultraviolet A (UVA) radiation even at ULTRAVIOLET RADIATION suberythemogenic doses. -
University of Dundee DOCTOR of MEDICINE Photoallergic Contact
University of Dundee DOCTOR OF MEDICINE Photoallergic contact dermatitis in Europe Kerr, Alastair Award date: 2012 Link to publication General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. • Users may download and print one copy of any publication from the public portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying the publication in the public portal Take down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Download date: 01. Oct. 2021 DOCTOR OF MEDICINE Photoallergic contact dermatitis in Europe Alastair Kerr 2012 University of Dundee Conditions for Use and Duplication Copyright of this work belongs to the author unless otherwise identified in the body of the thesis. It is permitted to use and duplicate this work only for personal and non-commercial research, study or criticism/review. You must obtain prior written consent from the author for any other use. Any quotation from this thesis must be acknowledged using the normal academic conventions. It is not permitted to supply the whole or part of this thesis to any other person or to post the same on any website or other online location without the prior written consent of the author. -
The Effects of Ultraviolet Filters and Sunscreen on Corals and Aquatic Ecosystems Bibliography
The Effects of Ultraviolet Filters and Sunscreen on Corals and Aquatic Ecosystems Bibliography Hope Shinn, Librarian, NOAA Central Library NCRL subject guide 2019-11 doi: 10.25923/hhrp-xq11 September 2019 U.S. Department of Commerce National Oceanic and Atmospheric Administration Office of Oceanic and Atmospheric Research NOAA Central Library – Silver Spring, Maryland Table of Contents Background & Scope ................................................................................................................................. 3 Sources Reviewed ..................................................................................................................................... 3 Section I: Corals and UV Filters ................................................................................................................. 4 Section II: Endocrine Disruption/Toxicology of Coral Reef Associated Organisms ................................. 10 Section III: Environmental Fate and Life Cycle of UV Filters in Marine Environments ........................... 25 Section IV: Concentrations of UV Filters in Marine Environments ......................................................... 51 Section V: Laboratory Studies on the Toxicity and Endocrine Disruption Effects of UV Filters .............. 94 2 Background & Scope The NOAA Coral Reef Conservation Program (CRCP) is in the process of evaluating research pertaining to coral reef health, especially as concerned with ultraviolet (UV) filters in sunscreen. To that end, the NOAA Central Library reviewed