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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. -
Technical Appendix to the Sunscreen Proposed Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Technical Appendix to the Sunscreen Proposed Rule 1 Table of Contents I. Overview ................................................................................................................................. 3 A. Definitions ........................................................................................................................ 3 II. Sunscreen Product Counts ...................................................................................................... 4 A. Sunscreen Product Search ................................................................................................ 4 B. Private Label Products ..................................................................................................... 6 C. Sunscreen Firms and Manufacturers ................................................................................ 7 D. Number of Relabeled and Reformulated Units ................................................................ 9 1. Relabeled Units............................................................................................................. 9 2. Reformulated Units....................................................................................................... 9 III. Sales by Product ................................................................................................................. 10 A. Total Market Sales ........................................................................................................ -
Sunscreen Faqs
Sunscreen FAQs What type of sunscreen should I use? There are two main types of sunscreen ingredients: physical sun blockers and chemical sunscreens. Physical sunscreens prevent ultraviolet light from reaching your skin, and contain either zinc oxide or titanium dioxide. Physical sunscreens protect against UVA and UVB damage. Physical sunscreens are preferred for patients with sensitive skin or children. Chemical sunscreens rely on an interaction between the sun and the chemical to protect your skin. Examples of such chemicals are avobenzone, octinoxate, homosalate, padimate O, and many others. Chemical sunscreens can protect against UVA, UVB, or both types of damage, depending on which ingredient is used. Read the label to ensure coverage for both UVA and UVB exposure. There are new ingredients being developed that take chemical sunscreens and stabilize them to prolong their activity (i.e., Helioplex, Mexoryl). Does the SPF really matter? In laboratory testing, there are minor differences between SPF 15 and SPF 30 or greater products. However, that data is based on using 1 oz. (30 gm.) of sunscreen for each full body application (the size of a shot glass). Most people use far less in real-life settings. For that reason, we recommend an SPF of at least 30. It is common to find good sunscreens with SPF ranging from 45-70. To maintain protection, reapply sunscreen every 1-3 hours, depending on sweating, water exposure, and sun intensity. Is sunscreen alone enough to protect my skin in the sun? In some cases, yes. However, if you are in the sun for longer periods on a regular basis (such as gardening, golfing, boating, sports), it may be better to add sun protective clothing or habits. -
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. -
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. -
Which Sunscreen Provides the Most Effective Protection Against UV Rays?
Which Sunscreen Provides the Most Effective Protection Against UV Rays? Haven Simmons Background information ● Ultraviolet (UV) rays are invisible rays that are part of the energy that comes from the sun. A common danger of UV rays is sunburns. Prolonged exposure to UV radiation may increase the risk of skin cancer. ● Sunscreen, also known as sunblock, is a lotion, spray, gel, foam, stick or other product that absorbs or reflects some of the sun's ultraviolet radiation and helps protect against sunburn. ● SPF stands for sun protection factor. It is a measurement of the sunscreen’s ability to protect skin from UVB rays. These rays damage the outermost layers of the skin. ● The best SPFs to use is 30 and below. Anything above 30 can sometimes be ineffective ● Some sprays have alcohol that may affect the skin or may not give enough protection. It is better to use if you play sports or do any physical activities outside. Lotions have better coverage since you have to rub it in. Lotions are very effective in preventing skin cell cancers. Background Information (Continued) ● Chemical based sunscreen absorbs the UV rays so your skin doesn't. Natural based sunscreen scatters the UV rays away from the skin. Chemical based sunscreen breaks down the UV rays easily but can irritate your skin. Natural doesn't have as good an effect as chemical but is best used for people with sensitive skin. ● Main active ingredients include: zinc oxide, titanium dioxide, and octinoxate. ● Zinc oxide is one of the most effective ingredients to have in sunscreen. -
Sun Safety and Protection Tips American Academy of Pediatrics
Sun Safety and Protection Tips American Academy of Pediatrics Spending time outdoors is a common activity on spring breaks or summer vacations, but remember to protect against the sun’s rays. Everyone is at risk for sunburn. Children especially need to be protected from the sun’s burning rays, since most sun damage occurs in childhood. Like other burns, sunburn will leave the skin red, warm, and painful. In severe cases, it may cause blistering, fever, chills, headache, and a general feeling of illness. The American Academy of Pediatrics offers tips to keep children safe in the sun. Sun Safety for Babies Under 6 Months Babies under 6 months of age should be kept out of direct sunlight. Move your baby to the shade under a tree, umbrella or stroller canopy. Dress babies in lightweight clothing that covers the arms and legs and use brimmed hats that shade the neck to prevent sunburn. When adequate clothing and shade are not available, parents can apply a minimal amount of sunscreen with at least 15 SPF (sun protection factor) on infants under 6 months to small areas, such as the infant's face and the back of the hands. Remember it takes 30 minutes to be effective. If an infant gets sunburn, apply cool compresses to the affected area. Sun Safety for Kids The first, and best, line of defense against harmful ultraviolet radiation (UVR) exposure is covering up. Stay in the shade whenever possible, and limit sun exposure during the peak intensity hours - between 10 a.m. and 4 p.m. -
Facts and Myths: Ultraviolet Light and Sun Protection
Facts and Myths: Ultraviolet Light and Sun Protection Katherine T. Steele, MD Assistant Professor of Clinical Dermatology University of Pennsylvania Fundamentals: Ultraviolet light Sunlight consists of 2 types of ultraviolet (UV) light • UVA • UVB • UVC (absorbed by the ozone in the earth’s atmosphere) Fundamentals: Ultraviolet light UVA rays • Premature aging – Dark spots – Wrinkles – Loose skin UVB rays • Sunburn Both UVA + UVB • Skin cancer Sun Protection: Facts What is the most effective way to protect your skin from the sun? 1) Avoiding sun exposure 2) Sun-protective clothing 3) Sunscreen Sun Avoidance UVB intensity peaks from 10 AM to 2 PM Note: UVA intensity is relatively constant throughout the day Avoid Peak Hours 6 AM 10 AM 2 PM 8 PM Which is the most effective way to protect your skin from the sun? 1) Avoiding sun exposure 2) Sun-protective clothing 3) Sunscreen Sun-protective clothing with UPF (ultraviolet protection factor) Benefits of sun-protective clothing • Once garment is on, it starts working immediately • Won’t wear off throughout the day • Not messy, oily or greasy • Non-allergenic • Potential cost savings: garments last many seasons • Created for Leisure and Sporting activities • Fashionable and trendy https://yoursummerskin.com/pages/about-upf-clothing Sun-Protective Clothing Sun Threadz Colleen Dougherty Bronstein Supporter of Melanoma Program at the Abramson Cancer Center of the University of Pennsylvania Which is the most effective way to protect your skin from the sun? 1) Avoiding sun exposure 2) Sun-protective clothing 3) Sunscreen Sunscreen: Facts Sunscreen labeling Broad-spectrum = Provides protection against both UVA + UVB Only broad-spectrum sunscreens with SPF 15+ can claim to reduce the risk of skin cancer and early skin aging. -
Coppertone Defend and Care Clear Zinc SPF 50 Drug Facts Active Ingredients Octinoxate 7.5%, Octisalate 4.5%, Zinc Oxide 9.7% Purpose Sunscreen
COPPERTONE DEFEND AND CARE FACE CLEAR ZINC SPF 50- octinoxate, octisalate, zinc oxide lotion Bayer HealthCare LLC. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Coppertone Defend and Care Clear Zinc SPF 50 Drug Facts Active ingredients Octinoxate 7.5%, Octisalate 4.5%, Zinc Oxide 9.7% Purpose Sunscreen Use Use ■ helps prevent sunburn Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Directions ■ shake well before use ■ apply liberally 15 minutes before sun exposure ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m. – 2 p.m. ■ wear long-sleeve shirts, pants, hats, and sunglasses ■ children under 6 months: Ask a doctor Other information Other information ■ protect this product from excessive heat and direct sun ■ may stain or damage some fabrics or surfaces Inactive ingredients -
Sunburn Overview Preventive Measures for Travelers
SUNBURN OVERVIEW Increased exposure to UV radiation occurs near the equator, during summer months, at high elevation, and between 10 AM and 4 PM. Reflection from the snow, sand, and water increases exposure, a particularly important consideration for beach activities, skiing, swimming, and sailing. In addition, several common medications may cause photosensitivity reactions in travelers: Acetazolamide Amiodarone Antibiotics (fluoroquinolones, sulfonamides, and tetracyclines, especially demeclocycline and doxycycline) Furosemide Nonsteroidal anti-inflammatory drugs Phenothiazines Sulfonylureas Thiazide diuretics Voriconazole UVA rays are present throughout the day and cause premature aging of the skin. In addition, UVA rays are responsible for photosensitivity reactions and also contribute to skin cancer. UVB rays are intense from 10 AM to 4 PM and are most responsible for sunburn and skin cancer. Serious burns are painful, and the skin may be tender, swollen, and blistered. These sunburns may be accompanied by fever, headache, itching, and malaise. Overexposure to the sun over several years leads to premature aging of the skin, wrinkling, age spots, and an increased risk for skin cancer, including melanoma. Repeated exposure to sunlight can result in pterygium formation, cataracts, and macular degeneration. PREVENTIVE MEASURES FOR TRAVELERS Sun Avoidance Staying indoors or seeking shade between 10 AM and 4 PM is very important in limiting exposure to UV rays, particularly UVB rays. Be aware that sunburn and sun damage can occur even on cloudy days and even when one sits under an umbrella or in the shade. Protective Clothing Wide-brimmed hats, long sleeves, and long pants protect against UV rays. Tightly woven clothing and darker fabrics provide additional protection.