Sunburn Overview Preventive Measures for Travelers
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Report of the Advisory Group to Recommend Priorities for the IARC Monographs During 2020–2024
IARC Monographs on the Identification of Carcinogenic Hazards to Humans Report of the Advisory Group to Recommend Priorities for the IARC Monographs during 2020–2024 Report of the Advisory Group to Recommend Priorities for the IARC Monographs during 2020–2024 CONTENTS Introduction ................................................................................................................................... 1 Acetaldehyde (CAS No. 75-07-0) ................................................................................................. 3 Acrolein (CAS No. 107-02-8) ....................................................................................................... 4 Acrylamide (CAS No. 79-06-1) .................................................................................................... 5 Acrylonitrile (CAS No. 107-13-1) ................................................................................................ 6 Aflatoxins (CAS No. 1402-68-2) .................................................................................................. 8 Air pollutants and underlying mechanisms for breast cancer ....................................................... 9 Airborne gram-negative bacterial endotoxins ............................................................................. 10 Alachlor (chloroacetanilide herbicide) (CAS No. 15972-60-8) .................................................. 10 Aluminium (CAS No. 7429-90-5) .............................................................................................. 11 -
May 23, 2007 Office of Pesticide Programs
May 23, 2007 Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P) Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460-0001 RE: Insect Repellent-Sunscreen Combination Products [EPA-HQ-OPP-2007-0087] Beyond Pesticides appreciates the prudent contemplation of insect repellent-sunscreen combination products EPA proposed in the reregistration eligibility decision (RED) for N,N-diethyl-meta-toluamide (DEET). We also appreciate this opportunity to share our concerns over these products. Beyond Pesticides interest in this issue lies in our effort to restrict pesticide use in a manner that protects public health and the environment, and to advance alternatives that eliminate dependency on toxic chemicals. We oppose the reregistration of all DEET-sunscreen combination products for the following reasons: 1. DEET exposure can result in negative health effects. As the agency notes, the registration of DEET is unusual in that it is one of few residential-use pesticides that is applied directly to the skin. The result is that the public is being exposed to a pesticide that has the ability to cause in lab animals increased fetal loss, bone and skeleton abnormalities in the offspring of rabbits, birth defects in birds, reduction in size of the testes and degeneration, and has produced abnormal sperm with reduced motility. Additionally, the public is directly applying a chemical to their skin that is demonstrated to cross the placenta and move into fetal blood in humans, has the ability to cause mutagenicity and oxidative stress, can decrease sensory and motor skills, causes skin irritation and kills brain cells.1 2. Sunscreen exposure can result in negative health effects. -
A Thesis Entitled Evaluating UVB and UVA Boosting Technologies For
A Thesis entitled Evaluating UVB and UVA Boosting Technologies for Chemical and Physical Sunscreens by An Ngoc Hiep Huynh Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Science Degree in Pharmaceutical Sciences Industrial Pharmacy ___________________________________________ Gabriella Baki, Ph.D., Committee Chair ___________________________________________ Jerry Nesamony, Ph.D., Committee Member ___________________________________________ Matthew W. Liberatore, Ph.D., Committee Member ___________________________________________ Dr. Amanda C. Bryant-Friedrich, Dean College of Graduate Studies The University of Toledo May 2020 Copyright 2020 An Ngoc Hiep Huynh This document is copyrighted material. Under copyright law, no parts of this document may be reproduced without the expressed permission of the author. An Abstract of Evaluating UVB and UVA Boosting Technologies for Chemical and Physical Sunscreens by An Ngoc Hiep Huynh Submitted to the Graduate Faculty as partial fulfillment of the requirements for the Master of Science Degree in Pharmaceutical Sciences Industrial Pharmacy The University of Toledo May 2020 There are currently 14 organic and 2 inorganic UV filters approved in the United States. Due to coral reef safety concerns, octinoxate and oxybenzone have been banned in Hawaii, Key West, FL and the US Virgin Islands; and octocrylene is also being studied for its potential impact on coral reef safety, leaving 11 organic UV filters as viable options for sunscreen manufacturers – with limitations on their combination. Since consumers are always looking for sunscreens with high SPF and broad-spectrum protection, the need for UVB and UVA protection boosting technologies is greater than ever. In a preliminary study, about two dozen emollients were scanned for their SPF boosting capability with selected organic UV filters. -
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. -
Sun Protection, Sunscreens and Vitamin D
SunSun protection,protection, sunscreenssunscreens andand VitaminVitamin DD GPGP NationalNational ConferenceConference RotoruaRotorua EnergyEnergy EventsEvents CentreCentre JuneJune 20092009 Dr. Louise Reiche Dermatologist New Zealand Dermatological Society Incorporated MelanomaMelanoma SkinSkin cancercancer andand sunlightsunlight Exposure to UVR causes > 90% of skin cancers Skin cancer is commonest cancer in NZ >50,000 new cases per year ~300 deaths per year ~$33.4 NZ million per year International Agency for Research on Cancer. IARC Monographs on the evaluation of carcinogenic risks to humans. Solar ultraviolet radiation. Lyon: International Agency for Research on Cancer, 1992. Armstrong BK. How sun exposure causes skin cancer. In: Hill D, Elwood JM, English DR, Eds. Prevention of Skin Cancer. Dordrecht: Kluwer Academic Publishers, 2004. O’Dea D. The Costs of Skin Cancer to New Zealand. Wellington: Cancer Society of New Zealand, 2000. New Zealand Health Information Service. Cancer, New Registrations and Deaths. Wellington: New Zealand Health Information Service, 2004. MelanomaMelanoma 1842 new cases in 2002 328 directly attributable to severe sunburn (Sneyd and Cox 2006) Authors recommended, “to reduce burden of melanoma in NZ, need to prevent excessive sun exposure and (facilitate) early diagnosis” Whilst cancer overall is rare in adolescence, melanoma was commonest cancer MelanomaMelanoma NZ incidence and death rate among world highest 56.2/100,000 in European population of Auckland highest reported worldwide men -
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. -
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. -
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) -
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]. -
United States Patent (19) 11 Patent Number: 6,086,858 Mceleney Et Al
US006086858A United States Patent (19) 11 Patent Number: 6,086,858 McEleney et al. (45) Date of Patent: *Jul. 11, 2000 54). COLORED FORMULATIONS FOR 4,818,491 4/1989 Fariss. APPLICATION TO HUMAN SKIN 4.954,544 9/1990 Chandaria. 5,426.210 6/1995 Kato et al.. 75 Inventors: John McEleney, Newton; Wende SS 8.1. R el, Restry BMS Curtis A. Vock, 5,562,8962- - -2 10/1996 Repperepper et al..al. s 5,567,420 10/1996 McEleney et al. ....................... 424/60 5,609,852 3/1997 Galley et al.. 73 Assignee: IPA, LLC, Forth Worth, Tex. 5,753,210 5/1998 McEleney et al. ....................... 424/59 c: 5,955,062 9/1999 McEleney et al. ... ... 424/59 * Notice: This patent is Subject to a terminal dis- 5,958,383 9/1999 McEleney et al. ....................... 424/59 CC. OTHER PUBLICATIONS 21 Appl. No.: 09/333,088 Deposition Transcript of Jack Katz, Feb. 10, 1999, pp. 1-32, 22 Filled: 15, 1999 regarding civil action entitled, Playtex Products, Inc. and 22 File Jun. 15, Sun Pharmaceuticals Corporation vs. Schering-Plough Related U.S. Application Data Healthcare Products, Inc., Case No. 98–482-RPM, United States District Court, Middle District of Delaware. 63 Continuation of application No. 09/217,170, Dec. 21, 1998, First Amended Complaint, IPA v Schering-Plough et al., which is a continuation of application No. 09/024,458, Feb. Civil Action No. 98–482 (RRM), Jan. 22, 1999, 14 pages. ship, alengageplain E. Defendants' Answer & Counterclaims to First Amended ation of application N. Soss 64.