May 23, 2007 Office of Pesticide Programs
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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 -
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. -
Jan 19, 2009 Listing of Generic, Non
http://www.medword.com/uspa.html Jan 19, 2009 Listing of generic, non-prescription, prescription, and OTC (over-the-counter) p harmaceuticals A-200 Gel Concentrate A-200 Shampoo Concentrate A-25 A-Cillin A-Fil A-Hydrocort A-methaPred A-Phedrin A-Spas S/L A Plus A.C. & C. A.P.L. A.R.M. Allergy Relief A.R.M. Maximum Strength Caplets A/B Otic A/Fish Oil A/T/S abacavir abarelix-depot-F abarelix-depot-M Abbokinase Abbokinase Open-Cath Abelcet Abenol Abitrate Absorbine Athletes Foot Absorbine Jock Itch Absorbine Jr. Antifungal AC acarbose Accolate Accupep HPF Accupril Accuretic Accutane Accutane Roche acebutolol Acel-Imune Acellular DTP Aceon Acet-2 Acet-3 Acet Codeine 30 Acet Codeine 60 Aceta Aceta Elixir Aceta Tablets acetaminophen acetaminophen-butalbital acetaminophen-caffeine acetaminophen-chlorpheniramine acetaminophen-codeine acetaminophen-dextromethorphan acetaminophen-diphenhydramine acetaminophen-hydrocodone acetaminophen-oxycodone acetaminophen-phenyltoloxamine acetaminophen-propoxyphene acetaminophen-propoxyphene hydrochloride acetaminophen-propoxyphene napsylate acetaminophen-pseudoephedrine acetazolam acetazolamide Acetest acetic acid Acetocot acetohexamide acetophenazine Acetoxyl 10 Gel Acetoxyl 2.5 Gel Acetoxyl 20 Gel Acetoxyl 5 Gel acetylsalicylic acid Achromycin Achromycin V aciclovir Acid Control Acid Phos Fluor Rinse Acilac Aciphex acitretin Aclophen Aclovate Acne-10 Lotion Acne-5 Lotion Acne-Aid Aqua Gel Acne-Aid Gel Acne-Aid Vanishing Cream Acne Aid 10 Cream Acne Lotion 10 Acne Prone Skin Sunscreen Acne Wash Acno Acnomel -
(12) United States Patent (10) Patent No.: US 8,551,508 B2 Lee Et Al
US008551508B2 (12) United States Patent (10) Patent No.: US 8,551,508 B2 Lee et al. (45) Date of Patent: Oct. 8, 2013 (54) COSMETIC, PERSONAL CARE, CLEANING 6,224,888 B1 5/2001 Vatter et al. AGENT, AND NUTRITIONAL SUPPLEMENT 4. R ck $398, ity, al. ......... 433/217.1 a O. ca. COMPOSITIONS AND METHODS OF 7.857.046 B2 12/2010 Lovell et al. MAKING AND USING SAME 2002/0114768 A1 8/2002 Stoor et al. 2004/0228905 A1 * 1 1/2004 Greenspan et al. ........... 424,445 (75) Inventors: Sean Lee, Karlsruhe (DE); Susanna Kessler, Ergolding (DE); Oliver FOREIGN PATENT DOCUMENTS Forberich, Oberursel (DE); Claire CN 1290.158 A 4/2001 Buchwar, Wiesbaden (DE); David C. JP 2001-516709 10, 2001 Greenspan, Gainesville, FL (US) JP 2001-52.5779 12/2001 WO 96.10985 4f1996 (73) Assignee: Schott AG, Mainz (DE) WO 97.27148 7/1997 WO 99.13852 3, 1999 (*) Notice: Subject to any disclaimer, the term of this WO 99.37287 7, 1999 WO WO9937287 * 7/1999 patent is extended or adjusted under 35 WO OOf 15167 3, 2000 U.S.C. 154(b) by 919 days. WO OO/42977 T 2000 WO 00,76486 12/2000 (21) Appl. No.: 11/775,615 WO 01.03650 1, 2001 WO O 1/72145 10, 2001 (22) Filed: Jul. 10, 2007 WO O 1/72262 10, 2001 OTHER PUBLICATIONS (65) Prior Publication Data US 2007/0275O21 A1 Nov. 29, 2007 Fechner, J., “Bioactive Glasses as a Potential New Class of Anti Oxidative Ingredients for Personal Care Products.” International Journal for Applied Science 131: Apr. -
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. -
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. -
Sunscreen: the Burning Facts
United States Air and Radiation EPA 430-F-06-013 Environmental Protection (6205J) September 2006 1EPA Agency Sun The Burning Facts Although the sun is necessary for life, too much sun exposure can lead to adverse health effects, including skin cancer. More than 1 million people in the United States are diagnosed with skin cancer each year, making it the most common form of cancer in the country, but screen: it is largely preventable through a broad sun protection program. It is estimated that 90 percent of non- melanoma skin cancers and 65 percent of melanoma skin cancers are associated with exposure to ultraviolet 1 (UV) radiation from the sun. By themselves, sunscreens might not be effective in pro tecting you from the most dangerous forms of skin can- cer. However, sunscreen use is an important part of your sun protection program. Used properly, certain sun screens help protect human skin from some of the sun’s damaging UV radiation. But according to recent surveys, most people are confused about the proper use and 2 effectiveness of sunscreens. The purpose of this fact sheet is to educate you about sunscreens and other important sun protection measures so that you can pro tect yourself from the sun’s damaging rays. 2Recycled/Recyclable—Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper How Does UV Radiation Affect My Skin? What Are the Risks? UVradiation, a known carcinogen, can have a number of harmful effects on the skin. The two types of UV radiation that can affect the skin—UVA and UVB—have both been linked to skin cancer and a weakening of the immune system. -
Alt-Health: Sunscreen, Summer and Skin Cancer
Alt-Health: Sunscreen, Summer and Skin Cancer Every time I research a health topic, I uncover something that surprises the crap out of me. I assumed that sunscreen protects us from the damaging effects of the sun. Turns out the opposite may be true — cases of skin cancer have actually increased since its introduction to the general market. The ancient Egyptians used plant extracts to protect against sun damage. Zinc oxide paste has been applied to noses for thousands of years. But it wasn’t until the late 1920s that inventors began producing synthetic commercial sunscreens. One of the first was invented in 1938 by Franz Greiter, the man who also invented SPF (sun protection factor.) He called his formula “Glacier Cream.” It had an SPF of 2. In 1944, Benjamin Green gave us Red Vet Pet, a sticky and largely ineffectual substance that was supplied to GIs in WWII. In 1950, Coppertone improved and reintroduced Red Vet Pet to the public as Coppertone Girl and Bain de Soleil. The first Coppertone ads featured a 4-year-old girl with her lips pursed in surprise as a cocker spaniel pulled her swimsuit down, revealing a pure white bottom in contrast to a burnished brown tan. “Don’t be a paleface!” the ad teases. It promises “a magic ingredient that screens out harmful burning sun rays.” People took this invitation at its word. In 2011 the US Food and Drug Administration finally released standards for sunscreen labels. By now it was known that sunscreen was not the protective panacea it had been heralded to be. -
Valisure Citizen Petition on Benzene in Sunscreen and After-Sun Care Products
May 24, 2021 Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Valisure Citizen Petition on Benzene in Sunscreen and After-sun Care Products Dear Sir or Madam: The undersigned, on behalf of Valisure LLC (“Valisure” or “Petitioner”), submits this Citizen Petition (“Petition”) pursuant to Sections 301(21 U.S.C. § 331), 501 (21 U.S.C. § 351), 502 (21 U.S.C. § 352), 505 (21 U.S.C. § 355), 601 (21 U.S.C. § 361), 602 (21 U.S.C. § 362), 702 (21 U.S.C. § 372), 704 (21 U.S.C. § 374), and 705 (21 U.S.C. § 375) of the Federal Food, Drug and Cosmetic Act (the “FDCA”), in accordance with 21 C.F.R. 10.20 and 10.30, to request the Commissioner of Food and Drugs (“Commissioner”) to issue a regulation, request recalls, revise industry guidance, and take such other actions set forth below. A. Action Requested Sunscreens are considered drugs that are regulated by the U.S. Food and Drug Administration (“FDA”).1 Valisure has tested and detected high levels of benzene in specific batches of sunscreen products containing active pharmaceutical ingredients including avobenzone, oxybenzone, octisalate, octinoxate, homosalate, octocylene and zinc oxide. The Centers for Disease Control and Prevention (“CDC”) states that the Department of Health and Human Services has determined that benzene causes cancer in humans.2 The World Health Organization (“WHO”) and the International Agency for Research on Cancer (“IARC”) have classified benzene as a Group 1 compound thereby defining it as “carcinogenic to humans.”3 FDA currently recognizes the high danger of this compound and lists it as a “Class 1 solvent” that “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity ..