Sun Protection, Sunscreens and Vitamin D
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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. -
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 -
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]. -
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 -
Ultraviolet Radiation
Environmental Health Criteria 160 Ultraviolet Radiation An Authoritative Scientific Review of Environmental and Health Effects of UV, with Reference to Global Ozone Layer Depletion V\JflVV ptiflcti1p cii ii, L?flUctd EnrrcmH Prormwe. Me World Haah6 Orgniri1ion and Fhc nIrrHbccrlT Ornrn)is5ion on Nfl-oflizirig Raditiori Prioiioii THE Ef4VIRONMEF4FAL HEALTH CI4ITERIA SERIES Acetonitrile (No. 154, 1993) 2,4-Dichloroplierioxyaceric acid (2 4 D) (No 29 Acrolein (No 127, 1991) 1984) Acrylamide (No 49, 1985) 2,4.Dichlorophenoxyucetic acd - erivirorrmerrtul Acr5lonilrile (No. 28, 1983) aspects (No. 54, 1989) Aged population, principles for evaluating the 1 ,3-Dichloroproperte, 1,2-dichloropropane and effects of chemicals (No 144, 1992) mixtures (No. 146, 1993( Aldicarb (No 121, 1991) DDT and its derivatives (No 9 1979) Aidrin and dieldrin (No 91 1989) DDT and its derivatives - environmental aspects Allethrins (No 87, 1989) (No. 83, 1989) Alpha-cypermethrirr (No 142, 1992) Deltamethrin (No 97, 1990) Ammonia (No 54, 1985) Diamirrotoluenes (No 74, 1987( Arsenic (No 18. 1981) Dichiorsos (No. 79, 1988) Asbestos and other natural mineral fibres Diethylhexyl phthalate (No. 131, 191112) (No. 53, 198€) Dirnethoate (No 90, 1989) Barium (No. 137 1990) Dimethylformnmde (No 114, 1991) Benomy( (No 143, 1993) Dimethyf sulfate (No. 48. 1985) Benzene (No 150, 1993) Diseases of suspected chemical etiology and Beryllium (No 106, 1990( their prevention principles of studies on Biommkers and risk assessment concepts (No. 72 1967) and principles (No. 155, 1993) Dilhiocarbsmats pesticides, ethylerrvthiourea, and Biotoxins, aquatic (marine and freshmaterl propylerrethiourea a general introdUCtiori (No 37, 1984) NO. 78. 1958) Butanols . four isomers (No. 65 1987) Electromagnetic Fields (No 1 '37 19921 Cadmiurrr (No 134 1992) Endosulfan (No 40. -
EWG Petitions CDC to Conduct Biomonitoring Studies for Common Sunscreen Chemicals
EWG Petitions CDC To Conduct Biomonitoring Studies for Common Sunscreen Chemicals May 22, 2019 To: U.S. Department of Health and Human Services Centers for Disease Control and Prevention National Center for Environmental Health Agency for Toxic Substances and Disease Registry 4770 Buford Hwy, NE Atlanta, GA 30341 Patrick Breysse, Ph.D., CIH Environmental Working Group (EWG), a nonprofit research and advocacy organization with headquarters in Washington, D.C., is petitioning the Centers for Disease Control and Prevention to add common sunscreen chemicals to the CDC’s Biomonitoring Program. EWG has been doing research on sunscreen ingredients since 2007, helping to educate the public about the importance of using sunscreens for health protection, as well as providing information about health risks that may be associated with certain ingredients used in sunscreen products. In response to a significant increase in the use of sunscreens in the United States and the associated increased potential for systemic exposure to the ingredients in these products, in February 2019, the Food and Drug Administration proposed a new rule for sunscreen products.1 The proposed rule would require sunscreen active ingredients to be assessed for their propensity to absorb through the skin and overall safety. Recently, the FDA completed tests on the absorbance of four common sunscreen active ingredients: avobenzone, oxybenzone, octocrylene, and ecamsule. As reported in a study published by the Journal of American Medical Association in May 2019,2 application of all four tested sunscreen ingredients resulted in plasma concentrations that exceeded the 0.5 ng/mL threshold proposed by the FDA for waiving systemic carcinogenicity studies as well as developmental and reproductive toxicity studies. -
Sun Protection
[ Oncology Watch] Sun Protection: What We and Our Patients Need to Know To preserve their health and the appearance of their skin, patients need straight- forward, practical advice on susncreen selection and protection strategies. By Jonathan Wolfe, MD rom preventing skin cancer to pre- measures protection against cutaneous burning. Even a FDA public education serving a youthful appearance, burning—the effects of UVB—and does piece states, “A higher number means it Fsunscreens play an important role not account for UVA radiation at all.5 As protects longer.”7 This is not a strictly in dermatologic care. However, some a result, a product with a high SPF could accurate interpretation of the SPF value confusion persists among patients and actually confer little or no protection and ignores the fact that unique proper- even some practitioners when it comes to against UVA. ties of the main sunscreen ingredients SPF, available chemical and physical sun- The somewhat esoteric description of (chemical or physical) and the formula- screens, and the best advice for sun SPF calculation is available online at the tion (waterproof, water resistant) influ- avoidance. In recognition of the AAD’s FDA website.6 Ultimately, the SPF num- ence duration of protection. Skin Cancer Detection and Prevention ber represents the ratio of the MED for Patients also often falsely assume that Month, I’ll review important patient protected skin (MED(PS)) to the MED the increase in SPF value is proportion- education points. for unprotected skin (MED(US)). Tests ate to the increase in UVB protection. It are conducted only in patients with skin is not. -
Sun Protection
DRUG NEWS Recommending the Best Sun Protection Clinical Pearls: o Recommend a “broad-spectrum” sunscreen – one that covers UVB, UVA1, and UVA2. o Recommend SPF 30-50 o Advise on non-pharmacological sun protection methods o Emphasize proper sunscreen application technique o Emphasize skin protection when taking drugs known to cause photosensitivity. Familiarize yourself with known implicated drugs by referring to appendix 2. Background 1-4 The sun emits 3 types of ultraviolet (UV) radiation: UVC (100-290 nm), UVB (290-320 nm), and UVA (320 -400 nm). UVA rays can be further divided into the shorter UVA2 rays and the longer UVA1 rays. UVC rays, the shortest rays, are completely absorbed by the ozone layer, whereas UVB rays penetrate the epidermis and UVA rays, the longest rays, penetrate into the dermis. The main consequence of UVB irradiation is sunburn, but can also include immunosuppression and skin cancer. Consequences of UVA radiation include: phototoxicity (i.e. involvement in drug-induced sun sensitivity reactions), photo-aging, immunosuppression, and skin cancer. What is SPF? 2,5,6,7 It is easy to be misled by Sun Protection Factors (SPF). SPF is assessed through a standardized test by finding the ratio of the minimal dose of solar radiation that produces perceptible erythema (i.e., minimal erythema dose) on sunscreen-protected skin compared with unprotected skin. Sunburn is caused primarily by UVB rays (and shorter UVA2 rays), and thus SPF indicates mostly UVB protection. However, UVA protection is equally important since it is responsible for photo-aging and cancer. Therefore, it is important to look for the phrase “broad spectrum” when choosing a sunscreen as broad spectrum indicates both UVB and UVA protection. -
Food and Drug Administration, HHS § 352.20
Food and Drug Administration, HHS § 352.20 (c) Cinoxate up to 3 percent. than 2 to the finished product. The fin- (d) [Reserved] ished product must have a minimum (e) Dioxybenzone up to 3 percent. SPF of not less than the number of (f) Homosalate up to 15 percent. sunscreen active ingredients used in (g) [Reserved] the combination multiplied by 2. (h) Menthyl anthranilate up to 5 per- (2) Two or more sunscreen active in- cent. gredients identified in § 352.10(b), (c), (i) Octocrylene up to 10 percent. (e), (f), (i) through (l), (o), and (q) may (j) Octyl methoxycinnamate up to 7.5 be combined with each other in a single percent. product when used in the concentra- (k) Octyl salicylate up to 5 percent. tions established for each ingredient in (l) Oxybenzone up to 6 percent. § 352.10. The concentration of each ac- (m) Padimate O up to 8 percent. tive ingredient must be sufficient to (n) Phenylbenzimidazole sulfonic contribute a minimum SPF of not less acid up to 4 percent. than 2 to the finished product. The fin- (o) Sulisobenzone up to 10 percent. ished product must have a minimum (p) Titanium dioxide up to 25 percent. SPF of not less than the number of (q) Trolamine salicylate up to 12 per- sunscreen active ingredients used in cent. the combination multiplied by 2. (r) Zinc oxide up to 25 percent. (b) Combinations of sunscreen and skin [64 FR 27687, May 21, 1999] protectant active ingredients. Any single sunscreen active ingredient or any per- EFFECTIVE DATE NOTE: At 67 FR 41823, June mitted combination of sunscreen ac- 20, 2002, § 352.10 was amended by revising tive ingredients when used in the con- paragraphs (f) through (n), effective Sept. -
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. -
United States Patent (19) 11 Patent Number: 4.959,205 Brunner Et Al
United States Patent (19) 11 Patent Number: 4.959,205 Brunner et al. 45 Date of Patent: Sep. 25, 1990 54 COMPOSTION AND METHOD FOR TREATMENT OF DERMAL FOREIGN PATENT DOCUMENTS NFLAMMATION 1539625 6/1976 United Kingdom . OTHER PUBLICATIONS (75) Inventors: Maureen Brunner, San Francisco; Howard Palefsky, Atherton, both of The Merck Index, 1976, 9th edition, pp. 629 and 630. Calif. B. Ljunggren et al, Arch Derm Forsch (1973)248:1-12. J. P. Callen et al, Arthritis Rheum (Aug. 1988) 31:1007-13. (73) Assignee: Collagen Corporation, Palo Alto, L. H. Kligman, J Invest Dermatol (1987) 88:12s-17s. Calif. A. D. Pearse et al, J Invest Dermatol (1987) 88:83-87. M. Pathak, Dermatologic Clin (1986) 4:321-34 (Pathak 21 Appl. No.: 327,488 I). M. Pathak et al, J Amer Acad Dernatol (1986) 22 Filed: Mar. 23, 1989 15:894-99, T. Schwartz et al, Dermatologica (1985) 171:450-58. (51) Int. Cl. ......................... A61K 7/40; A61K 7/42; L. E. Gibson et al, Geriatrics (1985) 40:87-92. A61K 31/56 K. Kyuki et al, JapJ Pharmacol (1983) 33:121-32. (52) U.S. C. ...................................... 424/59; 514/177; M. Pathak, JAmer Acad Dermatol (1982) 7:285-312. 514/847; 514/886; 514/887; 514/938 P. Peters et al, Agents & Actions (1977) 7:545-53. 58) Field of Search........................... 424/59; 514/887 Primary Examiner-Dale R. Ore Attorney, Agent, or Firm-Irel & Manella 56) References Cited (57) ABSTRACT U.S. PATENT DOCUMENTS Mild dermal inflammation, such as mild eczema and 4,083,974 4/1978 Turi......................................