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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). -
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. -
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. -
Kroger Co Disclaimer: Most OTC Drugs Are Not Reviewed and Approved by FDA, However They May Be Marketed If They Comply with Applicable Regulations and Policies
SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion The Kroger Co 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. ---------- Kroger 711 Active Ingredients Avobenzone 3% Homosalate 13% Octisalate 5% Octocrylene 7% Oxybenzone 4% Purpose Sunscreen Use helps prevent sunburn if used as directed with other sun protections measures (see Directions), decreases the rist of skin cancer and early skin aging caused by the sun 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 swallowed, get medical help or contact a Poison Control Center right away Directions 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 use a reqularly 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-sleeved shirts, pants, hats and sunglasses children under 6 months of age: Ask a doctor Other Information Protect the product from excessive heat and direct sun Inactive ingredients water, sorbitol, triethanolamine, VP/eicosene copolymer, stearic acid, sorbitan isostearate, aluminum starch octenylsuccinate, benzyl alcohol, dimethicone, tocopheryl, chlorphenesin, polyglyceryl-3 distearate, fragrance, carbomer, disodium EDTA Questions or comments? 1-800-632-6900 Adverse Reaction DISTRIBUTED BY THE KROGER CO. -
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. -
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. -
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. -
Determination of Sun Protection Factor (SPF) of Sunscreens by Ultraviolet Spectrophotometry
Revista Brasileira de Ciências Farmacêuticas Brazilian Journal of Pharmaceutical Sciences vol. 40, n. 3, jul./set., 2004 Determination of sun protection factor (SPF) of sunscreens by ultraviolet spectrophotometry Elizângela Abreu Dutra, Daniella Almança Gonçalves da Costa e Oliveira, Erika Rosa Maria Kedor- Hackmann*, Maria Inês Rocha Miritello Santoro Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo Uniterms: The aim of this research was to determine the sun protection factor • Sunscreens (SPF) of sunscreens emulsions containing chemical and physical • Cosmetic products sunscreens by ultraviolet spectrophotometry. Ten different • Sun protection factor commercially available samples of sunscreen emulsions of various • UV spectrophotometry manufactures were evaluated. The SPF labeled values were in the *Correspondence: range of 8 to 30. The SPF values of the 30% of the analyzed E. R. M. Kedor-Hackmann samples are in close agreement with the labeled SPF, 30% presented Departamento de Farmácia Faculdade de Ciências Farmacêuticas – SPF values above the labeled amount and 40% presented SPF UPS values under the labeled amount. The proposed spectrophotometric Av. Prof. Lineu Prestes, 580 – Bloco 13 – Cidade Universitária method is simple and rapid for the in vitro determination of SPF 05508-900 - São Paulo – SP – Brazil values of sunscreens emulsions. E-mail: [email protected] INTRODUCTION and is responsible for the damage due to sunburn. UVA radiation reaches the deeper layers of the epidermis and The rapid growth of commercially available products dermis and provokes the premature aging of the skin. containing sunscreens indicates that even though a suntan Ultraviolet radiations have been implicated as a causative is still desired, people are conscious of the possible dangers factor of skin cancer. -
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.