Preparation and Evaluation of Sunscreens Nanoemulsions Containing Avobenzone and Octyl Methoxycinnamate
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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 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 -
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. -
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. -
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. -
WO 2013/036901 A2 14 March 2013 (14.03.2013) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2013/036901 A2 14 March 2013 (14.03.2013) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 8/30 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/US2012/054376 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 10 September 2012 (10.09.2012) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, (26) Publication Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, (30) Priority Data: ZM, ZW. 61/532,701 9 September 201 1 (09.09.201 1) US (84) Designated States (unless otherwise indicated, for every (71) Applicant (for all designated States except US): UNIVER¬ kind of regional protection available): ARIPO (BW, GH, SITY OF FLORIDA RESEARCH FOUNDATION, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, INC. -
OSEQUE ZSOLE DUAL SUN BLOCK- Octinoxate Avobenzone Bisoctrizole Spray SONGHAK CO., LTD
OSEQUE ZSOLE DUAL SUN BLOCK- octinoxate avobenzone bisoctrizole spray SONGHAK CO., LTD. ---------- Active ingredients: Octyl Methoxycinnamate 7.5%, Ethylhexyl Salicylate 5%, Avobenzone 2%, Bisoctrizole 0.5% Purpose: Sunscreen Inactive Ingredients: Water, Alcohol Denat, Butylene Glycol, Glycerin, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Niacinamide, Isononyl Isononanoate, Glacier Water, Butyloctyl Salicylate, Xanthan Gum, Decyl Glucoside, Disodium EDTA, Methylparaben, Propylparaben, Fragrance Do not use: on wounds, rashes, dermatitis or damaged skin Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately Stop use: Please stop using this product and contact a dermatologist 1. If allergic reaction or irritation occurs 2. If direct sunlight affects the area as above When using this product: Do not use other than directed Warnings: For external use only. Not to be swallowed. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear Uses: Spray or apply liberally over the face and body 15 minutes prior to sun exposure. Always ensure total coverage of all sun exposed areas. Re-apply every 1-2 hours and always after swimming. For spray type, shake it well before use and spray it evenly at 20cm-30cm apart from face or wherever needed. For spray type - shake it well before use For lotion type - turn a cap to use Storage: Keep in a dry or room temperature area OSEQUE ZSOLE DUAL SUN BLOCK octinoxate avobenzone bisoctrizole spray Product -
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]. -
Salicylate UV-Filters in Sunscreen Formulations Compromise the Preservative System Efficacy Against Pseudomonas Aeruginosa and Burkholderia Cepacia
cosmetics Article Salicylate UV-Filters in Sunscreen Formulations Compromise the Preservative System Efficacy against Pseudomonas aeruginosa and Burkholderia cepacia Noa Ziklo, Inbal Tzafrir, Regina Shulkin and Paul Salama * Innovation department, Sharon Laboratories Ltd., Odem St. Industrial zone Ad-Halom, Ashdod 7898800, Israel; [email protected] (N.Z.); [email protected] (I.T.); [email protected] (R.S.) * Correspondence: [email protected]; Tel.: +972-54-2166476 Received: 15 July 2020; Accepted: 1 August 2020; Published: 3 August 2020 Abstract: Contamination of personal-care products are a serious health concern and therefore, preservative solutions are necessary for the costumers’ safety. High sun protection factor (SPF) sunscreen formulations are known to be difficult to preserve, due to their high ratio of organic phase containing the UV-filters. Salicylate esters such as octyl salicylate (OS) and homosalate (HS) are among the most common UV-filters currently used in the market, and can undergo hydrolysis by esterase molecules produced by contaminant microorganisms. The hydrolysis product, salicylic acid (SA) can be assimilated by certain bacteria that contain the chorismate pathway, in which its final product is pyochelin, an iron-chelating siderophore. Here, we show that OS and HS can compromise the preservative efficacy against two pathogenic important bacteria, Pseudomonas aeruginosa and Burkholderia cepacia. Challenge tests of formulations containing the UV-filters demonstrated that only bacteria with the chorismate pathway failed to be eradicated by the preservation system. mRNA expression levels of the bacterial pchD gene, which metabolizes SA to produce pyochelin, indicate a significant increase that was in correlation with increasing concentrations of both OS and HS. -
Cutaneous Permeation and Penetration of Sunscreens: Formulation Strategies and in Vitro Methods
cosmetics Review Cutaneous Permeation and Penetration of Sunscreens: Formulation Strategies and In Vitro Methods Silvia Tampucci * ID , Susi Burgalassi ID , Patrizia Chetoni ID and Daniela Monti ID Department of Pharmacy, University of Pisa, 56126 Pisa, Italy; [email protected] (S.B.); [email protected] (P.C.); [email protected] (D.M.) * Correspondence: [email protected] Received: 1 November 2017; Accepted: 7 December 2017; Published: 25 December 2017 Abstract: Sunscreens are the most common products used for skin protection against the harmful effects of ultraviolet radiation. However, as frequent application is recommended, the use of large amount of sunscreens could reflect in possible systemic absorption and since these preparations are often applied on large skin areas, even low penetration rates can cause a significant amount of sunscreen to enter the body. An ideal sunscreen should have a high substantivity and should neither penetrate the viable epidermis, the dermis and the systemic circulation, nor in hair follicle. The research of methods to assess the degree of penetration of solar filters into the skin is nowadays even more important than in the past, due to the widespread use of nanomaterials and the new discoveries in cosmetic formulation technology. In the present paper, different in vitro studies, published in the last five years, have been reviewed, in order to focus the attention on the different methodological approaches employed to effectively assess the skin permeation and retention of sunscreens. Keywords: sunscreens; formulation; in vitro methods; cutaneous permeation; skin penetration 1. Introduction The detrimental effects of human exposure to ultraviolet (UV) radiation have been widely investigated and can be immediate, as in the case of sunburns, or long-term, causing, in most cases, the formation of oxidizing species responsible of photo-aging, immunosuppression and chronic effects such as photo carcinogenicity [1,2].