Sunscreen: the Burning Facts
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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. -
Toxic Effects
Chapter 8 Toxic effects Toxic and other adverse effects studies of tens or hundreds of patients spectrum to which the skin is exposed of sunscreens (Thune, 1984; English et al., 1987; (Gasparro et al., 1998). Since UVB is the In order for a sunscreen to have a toxic Lenique et al., 1992; Szczurko et al., primary stimulus for adaptation of the effect on living tissues, it must penetrate 1994; Trevisi et al., 1994; Gonçalo et al., skin to sunlight, less adaptation might be the skin. There is some evidence that 1995; Ang et al., 1998) and reviews expected to develop in individuals who this can occur (see p. 63 et seq.). (Dromgoole & Maibach, 1990; Gonzalez use sunscreens regularly. The adaptive & Gonzalez, 1996; Schauder & Ippen, responses include thickening of the epi- Human studies 1997). In the past, PABA and its esters dermis and transfer of melanin-contain- No published studies of toxic effects in were the most commonly reported ing granules to keratinocytes (tanning) humans were available to the Working contact and photoallergens in sun- (Fig. 44), which reduces the trans- Group. screens (Funk et ai., 1997), and this find- parency of the skin to UVA and UVB ing contributed to a reduction in their use (Fusaro et al., 1966; Olson et al., 1973). Contact sensitivity in sunscreens. The contact or photocon- Several reports showed that UVR- There are numerous reports of cases of tact allergen in sunscreens most induced injury, such as dermal connec- allergic reactions and photoreactivity to frequently cited today is benzophenone- tive tissue damage and sunburn cell for- sunscreens, but the prevalence of this 3, followed by dibenzoyl methanes. -
Sun Lotion Chemicals As Endocrine Disruptors
HORMONES 2015, 14(1):32-46 Review Sun lotion chemicals as endocrine disruptors Sotirios Maipas, Polyxeni Nicolopoulou-Stamati National and Kapodistrian University of Athens, School of Medicine, First Department of Pathology and Cytology Unit, 1st Pathology Laboratory, Athens, Greece Both authors contributed equally to this work ABSTRACT Ultraviolet solar radiation is a well-known environmental health risk factor and the use of sun lotions is encouraged to achieve protection mainly from skin cancer. Sun lotions are cosmetic commercial products that combine active and inactive ingredients and many of these are associated with health problems, including allergic reactions and endocrine disorders. This review focuses on their ability to cause endocrine and reproductive impairments, with empha- sis laid on the active ingredients (common and less common UV filters). In vitro and in vivo studies have demonstrated their ability to show oestrogenic/anti-oestrogenic and androgenic/ anti-androgenic activity. Many ingredients affect the oestrous cycle, spermatogenesis, sexual behaviour, fertility and other reproductive parameters in experimental animals. Their presence in aquatic environments may reveal a new emerging environmental hazard. Key words: Active ingredients, Endocrine disruptors, Environmental hazard, Reproductive impair- ments, Sun creams, Sun lotions, Sunscreens, UV filters 1. INTRODUCTION ing, but the level of photoprotection is insufficient to prevent the harmful effects of UV radiation.3,4 Ultraviolet (UV) solar radiation is one -
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 -
Sunscreen Enhancement of Octyl Methoxycinnamate Microcapsules by Using Two Biopolymers As Wall Materials
polymers Article Sunscreen Enhancement of Octyl Methoxycinnamate Microcapsules by Using Two Biopolymers as Wall Materials Chuntao Xu 1,2 , Xuemin Zeng 3, Zujin Yang 4,* and Hongbing Ji 1,3,4,5,* 1 School of Chemistry and Chemical Engineering, Guangxi University, Nanning 530004, China; [email protected] 2 School of Information Engineering, Zhongshan Polytechnic, Zhongshan 528400, China 3 Fine Chemical Industry Research Institute, School of Chemistry, Sun Yat-Sen University, Guangzhou 510275, China; [email protected] 4 School of Chemical Engineering and Technology, Sun Yat-Sen University, Zhuhai 519082, China 5 School of Chemical Engineering, Guangdong University of Petrochemical Technology, Maoming 525000, China * Correspondence: [email protected] (Z.Y.); [email protected] (H.J.) Abstract: Octyl methoxycinnamate (OMC) is widely used as a chemical sunscreen in sunscreen cosmetics. However, its direct contact with the skin would bring certain risks, such as skin photo- sensitive reaction. How to improve the effect of skin photodamage protection has become a current research hotspot. Encapsulating ultraviolet (UV) filters into microcapsules is an interesting method to increase the photostability of filters. In this study, sodium caseinate (SC) and arabic gum (GA) are chosen as wall materials to prepare synergistic sunscreen microcapsules by complex coacervation technology. A series of experiments are conducted to investigate the effects of pH, wall material concentration, and wall/core ratio on the formation of OMC microcapsules. The morphology, com- position, and stability of OMC microcapsules are characterized by scanning electron microscopy Citation: Xu, C.; Zeng, X.; Yang, Z.; Ji, (SEM), Fourier transform infrared spectroscopy (FTIR), and thermogravimetric analysis (TGA). -
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. -
Use of Vegetable Oils to Improve the Sun Protection Factor of Sunscreen Formulations
cosmetics Article Use of Vegetable Oils to Improve the Sun Protection Factor of Sunscreen Formulations Lucia Montenegro * and Ludovica Maria Santagati Department of Drug Sciences, University of Catania, Viale A. Doria 6, 95125 Catania, Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-095-7384010 Received: 11 March 2019; Accepted: 1 April 2019; Published: 8 April 2019 Abstract: Some vegetable oils have many biological properties, including UV-absorbing capacity. Therefore, their use has been suggested to reduce the content of organic UV-filters in sunscreen products. In this work, we investigated the feasibility of developing oil-based vehicles with a high sun protection factor (SPF) using pomegranate oil (PMG) and shea oil (BPO) in association with different percentages of organic UV-filters (octyl– methoxycinnamate, butyl methoxydibenzoylmethane, and bemotrizinol). We characterized the spreadability, occlusion factor, pH, and required hydrophilic lipophilic balance of the resulting formulations, and did not observe relevant differences due to the incorporation of vegetable oils. The in vitro spectrophotometric determinations of SPF values highlighted that the addition of BPO (1% (w/w)) and PMG (1% (w/w)) resulted in an increase in SPF in comparison with the same formulations that contained only organic UV-filters. The SPF increase was more significant for the formulations that contained lower amounts of organic UV-filters. The results of this study supported the hypothesis that including suitable vegetable oils in sunscreen formulations could be a promising strategy to design products with a lower content of organic UV-filters. Keywords: sunscreens; vegetable oils; sun protection factor; oil-based vehicles; occlusion; spreadability 1. -
A Bottom-Up Approach to Photoprotection
Journal of Photochemistry and Photobiology A: Chemistry 353 (2018) 376–384 Contents lists available at ScienceDirect Journal of Photochemistry and Photobiology A: Chemistry journal homepage: www.elsevier.com/locate/jphotochem Photophysics of the sunscreen ingredient menthyl anthranilate and its precursor methyl anthranilate: A bottom-up approach to photoprotection a a a a,b c N.D.N. Rodrigues , N.C. Cole-Filipiak , M.D. Horbury , M. Staniforth , T.N.V. Karsili , d a, Y. Peperstraete , V.G. Stavros * a University of Warwick, Department of Chemistry, Coventry, CV4 7AL, UK b University of Warwick, Department of Physics, Coventry, CV4 7AL, UK c Temple University, Department of Chemistry, Philadelphia, PA 19122, USA d Synchrotron SOLEIL, AILES Beamline, L’Orme des Merisiers, Saint Aubin, BP48, 91192 Gif Sur Yvette Cedex, France A R T I C L E I N F O A B S T R A C T Article history: Received 3 October 2017 The ultrafast excited state dynamics of the sunscreen ingredient menthyl anthranilate (MenA) and its Received in revised form 22 November 2017 precursor methyl anthranilate (MA) were studied in vacuum (using time-resolved ion yield spectroscopy) Accepted 23 November 2017 and in solution (using transient electronic absorption spectroscopy). MenA and MA both show long-lived Available online 1 December 2017 dynamics, with the observation of a kinetic isotope effect suggesting that hydrogen motion acts as the rate determining process in the overall decay. Complementary computational studies exploring the Keywords: intuitive decay pathways of MA revealed a bound S1 state with a shallow ‘up-hill’ gradient with respect to Photochemistry proton transfer. -
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.