Cosmetiscope March 2015

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MARCH 2015 • Vol. 21 No. 3

New York Society of Cosmetic Chemists

www.nyscc.org

The Road to the Sunscreen Innovation Act … by Nadim A. Shaath

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resident Obama finally signed the Sunscreen Innovation Act (SIA) into law in late November 2014. This process has taken years to achieve. As most of us know, the Final Monograph in sunscreens in the U.S. has not been finalized. An uneven bureaucracy and delays have prolonged a tenuous situation, leaving a population at risk. The process of regulating sunscreens started in the early seventies, forty years ago, culminating in the publication of the Advanced Notice for Public Record (ANPR) in 1978. The ANPR seemed to function as law for numerous years with suppliers, manufacturers, and consumers adhering to its tenets. It provided guidelines and testing protocols for sun protection factors (SPF), specifying SPF 15 as the highest SPF possible. It also provided a list of twenty-one ingredients that were labeled Category I that had a specific use percentage in cosmetic formulations. It allowed manufacturers to make a claim that, “The use of sunscreens reduces the risk of skin cancer and early skin aging when used as directed.” Soon it was discovered that SPF 15 was inadequate in protecting consumers from the ravaging rays of the sun and that the twenty-one filters were insufficient. For one thing, only titanium dioxide and red petrolatum were considered “physical” blockers of ultraviolet radiation, and zinc oxide was not yet approved. It took years for the FDA to include zinc oxide in its Category I listing. New research uncovered that UVA protection is paramount and that the benzophenones and menthyl anthranilate (meradimate) are the only four ingredients apart from the inorganic filters that protect the consumer from UVA rays. These ingredients were obviously inadequate to properly protect the consumers from UVA, especially from UVA-1. Companies were prompted to introduce better UVA filters in the U.S., but met with an inflexible bureaucracy. The first such ingredient, avobenzone, was introduced into the U.S. by Givaudan (later on it was marketed by Roche). They soon discovered that the only mechanism to introduce a UV filter in the U.S. was through a New Drug Application (NDA). Givaudan pursued that process and obtained an NDA for avobenzone with Herbert Laboratories in California. The problem with this process is that when you deal with drugs, the issue of dosage and combinations with other active and inactive ingredients generally requires an amended NDA every time an ingredient change is requested! In cosmetics, we live and die by changing the percentages of ingredients, including new excipients, and modifying the chemical and physical characteristics to produce lotions, creams, aerosols, gels, mousses etc. Flexibility is key, permitting responsiveness to the market. Thus, the original formula that contained padimate O (2-ethylhexyl 4-dimethylaminobenzoate) with avobenzone had to be changed in the 1990s when that ingredient fell out of favor. Another costly NDA! (Continued on page 6)

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2015 NYSCC BOARD OF DIRECTORS & PROGRAM CHAIRS

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CHAIR Kim Burch (609) 443-2385 Kim.Burch@elementis.com

CHAIR-ELECT Rey Ordiales (732) 878-7798 reyordiales@outlook.com.

TREASURER Marie Thadal (609) 712-3716 nyscctreasurerelect@gmail.com

SECRETARY Jenna Jelinski (201) 396-8431 jjelinski@morretec.com

ADVISOR Steve Neidenberg sbn605@aol.com

HOUSE John Carola JohnC@protameen.com

MEMBERSHIP Amy Marshall (908) 806-4664 amy.marshall@altana.com

PROGRAM John Goffredo (201) 647-1841 jagformulators@gmail.com

COMMUNICATIONS Judith Bernabé (201) 526-4650 jude.bernabe@gmail.com

SPECIAL EVENTS Phil Klepak (973) 265-2869 pklepak@summitresearchlabs.com

COSMETISCOPE EDITOR Roger McMullen roger_mcmullen@fdu.edu

COSMETISCOPE ASSISTANT EDITOR Joe Albanese (908) 456-2968 j.albanese@3vusa.com

COSMETISCOPE ADVERTISING Bret Clark rbclark@ashland.com

COSMETISCOPE EMPLOYMENT Jason O’Neill (631) 252-2939 Jason.Oneill@kemin.com

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Unemployed and Emeritus members may continue to attend monthly meetings free of charge. Please contact the registration booth upon arrival. Unemployed members may also continue their membership free of charge by submitting the renewal form with unemployment details. Please remember that the SCC Employment Service is here to assist you. Contact: Jason O’Neill • E-Mail: Jason.Oneil@kemin.com

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Helena Rubinstein: Beauty Is Power Friday, March 13, 2015 The Jewish Museum

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elena Rubinstein was a legendary cosmetics entrepreneur whose ideas challenged and changed the myth of feminine beauty. This exhibit is devoted to her life and art collection, and presents a strong female perspective on 20th century visual culture. She introduced new and different standards of beauty, and exhorted women to control their own image though makeup and grooming. Today, the term “beauty salon” is limited to a hair dresser or day spa. However, Rubinstein’s salon was designed as a place where women could learn not only how to improve their looks, but also how to reconceive their standards of taste, and to understand design, color, and art to express their own personalities.

Location: The Jewish Museum, 1109 5th Ave. (at 92nd Street), NY, NY Time: Guided tours at 1:00 pm and 2:00 pm. Each group limited to 20 persons. Cost/Registration: • NYSCC Pre-registered Member $85.00 • Pre-registered non-member $105.00 • Emeritus/students pre-registered $40.00 • Emeritus at the door $75.00 • At the door $120.00 Register online by visiting the NYSCC website at www.nyscc.org. • Limited to the first 40 people. • Price includes: guided tours of “Beauty is Power.” • General admission to the museum. • Discount coupons for the museum store. • Bus transportation from New Jersey. • Validated parking for cars parked at private garage.

For more information: https://nyscc.org/event-calendar/

2015 NYSCC Practical Rheology Course Princeton University • Princeton, NJ

March 19-20, 2015 Instructor: Dr. Hemi Naé, Ph.D.

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he NYSCC is returning to Princeton University for another event covering the science of rheology. This year we are happy to announce that we contracted with Dr. Hemi Naé of Hydan Technologies to bring us his acclaimed twoday Practical Rheology Course. The course will be taught on March 19th and 20th at the Friend Center on the Princeton University campus. This special in-depth course is for everyone working in technical marketing, research, development, processing, and quality control and tailored to the needs of the personal care industry. Joining Hemi will be instrument vendors to explain and demo their rheometers. The NY Chapter is proud to host this course at significantly reduced rates of $175 for SCC members and $250 for non-members. Emeritus members and students may attend for only $50. Registration also includes lunch plus food and beverage for morning and afternoon intermissions. Course materials will be distributed to every registrant. Registration on nyscc.org commenced in mid-January. Costs for late registration (after March 5, 2015) will be about 50% higher. The course will be limited to 150 attendees. So, if you are truly interested, we suggest you avoid being disappointed and the applied late fees by registering early.

For registration information, please visit www.nyscc.org. V O L U M E

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Fragrance Chemistry April 7, 2015 • The Bethwood, Totowa, NJ 38 Lackawanna Avenue, Totowa, NJ 07512 • Tel: (800) 377-8316 Open registration: 4:00 PM Educational Hour: 4:30 PM • Dinner: 5:30 PM Chapter Meeting Speaker: 6:30 PM EDUCATIONAL HOUR SPEAKER Speaker: Topic:

Steve Herman Fragrance Safety and Transparency

Abstract:

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hat is in a fragrance and how do we know it is safe? RIFM (Research Institute for Fragrance Materials) is the industry organization that establishes the test protocols, generates and analyzes the data, and publishes the results in peer-reviewed journals. The basic philosophy guiding the safety evaluation is contained in a series of guidance documents. A new broad based guidance document was made public in December 2014, incorporating the latest toxicological science. We will examine its basic assumptions and procedures including the decision tree approach and the introduction of the Threshold of Toxicological Concern (TCC) into the evaluation process. Since fragrance formulas are generally kept confidential, we will examine a prototype formula that illustrates how the regulatory analysis is conducted to establish IFRA (International Fragrance Association) compliance and how VOCs are calculated for CARB (California Air Resources Board) standards.

Biography:

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teve Herman is President of Diffusion LLC, a consulting company specializing in regulatory issues, intellectual property, and technology development and transfer. He is also a principal in PJS Partners, offering comprehensive technical, formulation, and marketing services to the personal care industry. He has been an Adjunct Professor in the FDU Cosmetic Science Program since 1993, teaching the Cosmetic Formulation Lab and Perfumery. Steve is a regular columnist for GCI Magazine and has written a book, Fragrance Applications: A Survival Guide. His SCC activities include service as Chairman of the New York chapter in 1992 and 2013, election to Fellow status in 2002, and instructor in the Continuing Education Program.

NYSCC MONTHLY MEETING REGISTRATION: Online at: www.nyscc.org For questions, contact: Roumelia Alina at roumelia.alina@lucasmeyercosmetics.com (914) 434-2529.

CHAPTER MEETING COST: Pre-registered SCC members: $35 ($70 at door) • Pre-registered non-SCC members: $75 ($110 at door) Students: $10 ($50 at door) • Emeritus: Free ($40 at door)

Monthly Meeting Group Discount The NYSCC is offering a group discount of 15% to companies who send 5 or more employees to a monthly meeting. All five employees would need to be registered at the same time to receive the discount. Once purchased, registrations are non-refundable.

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John C. Brahms, Ph.D. Enhancing the Consumer Experience through Fragrance Delivery

Abstract:

COMMITTED TO TECHNOLOGY FORMULA AND SUPERIOR T NA ATION-WIDE DISTRIBUTION.

Authorized Dealer

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s an integral part of nearly every consumer product on the market today, fragrances help to mask base odor as well as communicate product benefit to the consumer. In many products, fragrance is the key end benefit in its own right. Encapsulation technologies enhance these benefits by protecting the fragrance during manufacturing and storage while providing a mechanism of release at the appropriate consumer relevant time point during and after use. Because fragrances are complex mixtures of organic compounds, encompassing a range of functionality, water solubility, and volatility, designing encapsulation systems that can accommodate the widest range of fragrance materials is often challenging. The unique challenges in applying these techniques to fragrance delivery as well as their effect on stability and performance in end use applications as well as future challenges and opportunities related to fragrance encapsulation will be discussed.

800.296.4942 LINCOLNFINEINGREDIENTS.COM 50 INDUSTRIAL CR., LINCOLN, R.I., 02865

Biography:

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r. Brahms is currently an R&D Director at International Flavors and Fragrances. He was born and raised in New Jersey, and later completed a B.S. in Chemical Engineering at Drexel University. He then went on to study Physical Organic Chemistry at the University of Pennsylvania where he obtained his Ph.D. John has worked at a number of corporations in the personal care arena including Colgate-Palmolive, Avon Products, Coughlan Products, and International Flavors and Fragrances. He is a member of the American Institute of Chemical Engineers, American Chemical Society, and Controlled Release Society. John is also a member of Sigma XI (The Scientific Research Society) and Phi Lamda Upsilon. He has over thirty patents and publications.

™ Nature’s Science. Our Technology. Your Beauty.

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Directions to The Bethwood, Totowa, NJ 38 Lackawanna Avenue, Totowa, NJ 07512 • Tel: (800) 377-8316

• • • • • • • • • •

• Garden State Parkway South: Go through Saddle Brook toll and then take Exit 159 to Route 80 West (approximately 8 miles) to Exit 55A; at the first traffic light, make a left onto Lackawanna Avenue. • Garden State Parkway North: Take Exit 153B to Route 3 West to Route 46 West (approximately 2 1/2 miles) to the Union Boulevard, Totowa, Paterson exit; at the first traffic light, make a right onto Lackawanna Avenue. • New Jersey Turnpike North: Take Exit 16W to Route 3 West (approximately 9 miles) to Route 46 West (approximately 2 1/2 miles) to the Union Boulevard, Totowa, Paterson exit; at the first light, make a right onto Lackawanna Avenue. Lincoln Tunnel: Route 3 West to Route 46 West; follow instructions from Route 46 West. Holland Tunnel: To New Jersey Turnpike North. See instructions above. Route 80 West: To Exit 55A (Little Falls/Totowa, Union Boulevard); at the first light, make a left onto Lackawanna Avenue. Route 80 East: To Exit 54 (Minisink Road); at the stop sign make a right then take the first left (Furler Street) through traffic light. The Bethwood is on the left after the light. Route 46 West: Take the Union Boulevard, Totowa exit; at the first light, make a right onto Lackawanna Avenue. Route 46 East: Take the Union Boulevard, Totowa exit; at the light make a left onto Union Boulevard. At the first light, make a right onto Lackawanna Avenue. The Bethwood is 500 feet on the left. 287 North: Follow to Route 80 East; follow instructions for Route 80 East above. George Washington Bridge: Follow the signs to Route 80 West; see Route 80 West above. Route 23: Follow to Route 46 East; follow instructions for Route 46 East above. Staten Island: From the Goethals Bridge take New Jersey Turnpike North to Exit 16W; follow instructions from New Jersey Turnpike North above.

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Soon after, the industry realized that the NDA route was too costly, too time-consuming, and notoriously impractical. Cosmetics need to vary from one another to achieve a commercial advantage. The lesson of avobenzone was costly and impractical. What complicated the situation even more was the inherent photo-instability of avobenzone. It totally broke down in non-aqueous formulations and desperately needed to be stabilized with photostabilizers and quenchers. L’Oréal, at the time, figured this out and applied and received patents for photostabilizing avobenzone with octocrylene. Needless to say, the industry took its case to the FDA, who held several hearings in Washington D.C. I personally testified at the hearings to include avobenzone in our formulations and classify it as a Category I ingredient since it was an excellent UVA absorber, albeit its inherent photo-instability. Avobenzone was finally included in the Category I listing with a use level of 1-3% in 1996. Avobenzone became the workhorse UVA ingredient and a whole new industry termed photostabilizers and boosters was born. Boosters are products, which contain a host of ingredients including quenchers, singlet-singlet, triplet-triplet, and excited state quenchers. With the FDA seemingly busy with other matters, this new industry was never regulated or even addressed by them! Roll forward a decade or two since the introduction of avobenzone and the incidence of skin cancer in the U.S. escalating with figures reported as high as two million new cases of skin cancer occurring in the USA each year! A public outcry was heard, and numerous organizations and health advocates were organized to combat the epidemic rise of skin cancers in the U.S. Also, it was clearly apparent that you could not get adequate UVA protection from benzophenone-3 (oxybenzone) and photostabilized avobenzone. Practitioners started looking at what the Europeans and the rest of the world have for better UVA protection. So, over a dozen years ago, several sunscreen and filter manufacturers applied to the FDA, under a newly discovered process entitled Time and Extent Application (TEA), to get those UV filters that were being used successfully in Europe approved in the USA. This process requires that a UV filter that is approved and sold in five different countries substantially for at least five years, and would be eligible for approval under the TEA guidelines of the U.S. The TEA process turned out to be a panacea. What was supposed to be a process that would take a maximum of one year has now stretched to twelve years with no end in sight. We had numerous meetings about this lack of progress with the FDA to no avail. The solution? Learn from the lobbyists. Emulate what the gun, oil, tobacco, and pharmaceutical lobbies do to bring their case to the U.S. Congress in pursuit of legislation that protects and furthers their interests in the U.S. A group of cosmetic and UV filter manufacturers along with many scientists, dermatologists, and skin cancer prevention advocate organizations got together and formed the PASS (Public Access for Safe Sunscreens) Coalition.

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Figure 1. Molecular structure of oxybenzone (benzophenone-3).

Figure 2. Molecular structure of dioxybenzone (benzophenone-8).

Figure 3. Molecular structure of sulisobenzone (benzophenone-4).

Figure 4. Molecular structure of menthyl anthranilate (meradimate).

Figure 5. Molecular structure of avobenzone (butylmethoxydibenzoylmethane).

Figure 6. Molecular structure of padimate O (2-ethylhexyl dimethyl PABA).

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Figure 7. Molecular structure of bisoctrizole (methylene bis-benzotriazolyl tetramethylbutylphenol).

Figure 8. Molecular structure of bemotrizinol (bis-ethylhexyloxyphenol methoxyphenyl triazine).

Figure 9. Molecular structure of ecamsule (terephthalylidene dicamphor sulfonic acid).

Figure 10. Molecular structure of drometrizole trisiloxane.

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Remarkably, in a relatively short period, the coalition succeeded in finding advocates in both the House and the Senate that were willing to sponsor a bill in support of sunscreen innovation. Co-sponsors in both the House and the Senate were soon selected, and the final bill, called the SIA, was passed unanimously at both the House and the Senate with the final version signed into law by President Obama in late November 2014. We now have a new law in the land. This law presumably mandates that the FDA should decide within a short period of time on the merits of approving the eight TEA ingredients. Two of those ingredients, namely bisoctrizole and bemotrizinol, are extremely efficient and are desperately needed UVA filters. Also, two other ingredients, namely ecamsule and drometrizol trisiloxane, are on the list, but are under patent for L’Oréal’s use only. These four ingredients, when approved, will go a long way in providing American consumers better UVA and overall sunscreen protection. What will the impact of the SIA be? 1. If the four UVA filters are approved via the TEA process, the U.S. will have far superior UVA protection. Of course, this will impact the current formulations that contain avobenzone with photostabilizers. 2. Once the European ingredients, which are designed on the Dalton 500 rule, have been approved in the U.S., the need for some of the small molecule UV filters such as the cinnamates, salicylates, and benzophenones should decline rapidly. Some of those ingredients have been recently implicated in phototoxicity and endocrine disrupting issues. 3. Presumably the SIA will be a catalyst in getting the FDA to finalize the Sunscreen Monograph which will impact all the pending issues, namely: a. The maximum SPF allowed for a cosmetic product. b. The safety and use of spray products. c. The safety and efficacy of all Category I ingredients. d. The combinations of avobenzone with inorganic filters such as zinc oxide and titanium dioxide. 4. It is my hope that with the passage of the SIA, the FDA and consumers will all realize that protection from the ravaging rays of the sun includes other practices and behaviors. This includes protection from most rays of the sun, not only just ultraviolet radiation, but infrared radiation in particular. Proper application of sunscreen ingredients should be strictly adhered to by the consumer. Avoiding the harsh sun from 10:00 a.m. – 3:00 p.m. whenever possible is prudent, and the use of proper clothing, hats, and umbrellas, and overall better education on the sun’s harmful effects, are paramount.

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The stifling of ultraviolet filter R&D efforts in the U.S. is unconscionable. Lessons should be learned from this unproductive period. Incentives must be given, and faster routes to market superior UV filters must be facilitated and (Continued on page 8)

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The Road to the Sunscreen Innovation Act

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approved, including new and improved methods to reverse the early onset and developing stages of skin cancer. It is my hope that research into new ingredients and better protocols of protection are encouraged. Innovation is our only hope. May the SIA usher in a new era in UV filters, sunscreen development, and skin cancer protection. †The commentaries on the status of the sunscreen industry are the author’s personal views and do not necessarily reflect those of the PASS Coalition or other organizations with whom he is affiliated.

About the Author:

Dr. Nadim Shaath received his Ph.D. in Organic Chemistry from the University of Minnesota. He joined the Chemistry Faculty at the State University of New York at Purchase and became its Chairman. He is currently the President of Alpha Research & Development, Ltd. and Shaath & Meadows Consultation. Dr. Shaath is the author and editor of several books on sunscreens and ultraviolet filters, and writes a bimonthly column in HAPPI entitled “The Sunscreen Filter.”

Call for Papers

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he Cosmetiscope editorial committee invites all interested parties to submit feature technical articles for publication in the NYSCC monthly newsletter. Authors of feature articles are eligible to win the prestigous NYSCC Literature Award ($1,000) for the best front-page article published during the calendar year. Also, authors receive $200 reimbursement to attend a theatrical performance of their choice. Writing an article for your peers is a very rewarding experience, both personally and professionally, and would reserve your place in NYSCC history. You may choose whatever topic you feel would be interesting to fellow colleagues in our industry. We also welcome any other types of commentaries or articles that may be published in the Career Corner, Technical Tidbit section, or as a Letter to the Editor. Please send correspondence to: roger_mcmullen@fdu.edu.

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89th ACS Colloid & Surface Science Symposium Carnegie Mellon University • Pittsburgh, PA

June 15-17, 2015 For more info: http: www.colloids2015.org.

University of Pennsylvania Philadelphia, PA

June 22-23, 2015 More info: http://summit.cosmeticsandtoiletries.com

GORDON RESEARCH CONFERENCE

Barrier Function of Mammalian Skin Defining, Investigating and Surmounting the Barrier

August 16-21, 2015 Waterville Valley Resort Waterville Valley, New Hampshire More info: www.grc.org V O L U M E

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C BOTANICAL EMOLLIENTS & SPECIALTY PARTICLES

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DWI Leibniz-Institut für Interaktive Materialien HairS’15 19th International Hair Science Syposium • Trier, Germany

September 2-4, 2015

In the New York SCC Region:

Abstract Submission

Essential Ingredients Michael Manning 201.576.9382

Proposals for oral/poster presentation (1 page max.) should be sent to: hairs15@dwi.rwth-aachen.de by March 27, 2015.

mmanning@essentialingredients.com

Symposium Fee Early bird fees for registration and payment by August 1, 2015 are: • 770€ for participants • 590€ for DWI member companies • 330€ for speakers (one presenting author per oral presentation, no reduction for poster authors) Fee includes meals, coffee breaks, excursion, conference dinner, book of abstracts, and conference proceedings.

For more info: www.dwi.rwth-aachen.de.

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The US Society of Cosmetic Chemists hosts the 29th IFSCC Congress O

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October 23-26, 2016 Lake Buena Vista, Florida

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Walt Disney World Dolphin Resort

29TH CONGRESS

O R L A N D O, F L 2 016 INS PIRE IMAGINE INNOVATE

Beyond Dreams into New Frontiers: Inspire, Imagine, Innovate

Make note of it… Send news of interest, guest editorials, and comments to Roger McMullen, Editor • E-mail: roger_mcmullen@fdu.edu 10

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Upcoming 2015 NYSCC Events Calendar Making Personal Personal Car Caree Beautiful®

Specialty Silicones & Actives Skin Car Caree Caree Hair Car Color Cosmetics ®

www.biosiltech.com

• For updated NYSCC information, visit us on the web at: www.nyscc.org • For National SCC information: www.scconline.org March 19-20

Rheology Class, Princeton University, Princeton, NJ

April 7

NYSCC Monthly Meeting, Fragrance Chemistry, The Bethwood, Totowa, NJ

May 11

India Seminar, Renaissance Hotel, Iselin, NJ

May 12-13 June 10 August TBD September 18 September TBD September 29 October 24 November 11-12 November TBD December 10

Suppliers’ Day, Edison, NJ NYSCC Monthly Meeting, Green Chemistry, Aqua Azul Yacht, Weehawken, NJ NYSCC Golf Outing, Location TBD Culinary Event, Midtown Loft, New York, NY NYSCC Workshop, Location TBD Safety and Regulatory Workshop, Location TBD NYSCC 60th Anniversary Party, Glennpoint Marriot, Teaneck NJ NYSCC Color Cosmetics Symposium, Location TBD NYSCC Board Transition Meeting NYSCC Social Media Holiday Party, New York, NY

Employment Opportunities For complete ads please go to the NYSCC website: https://nyscc.org/employment/employment-listings/

n Sales & Market Development Manager Vertellus Specialties, Inc., Mid-Atlantic Region

n Research and Technical Specialist – PVCS Croda, Edison, NJ

n Territory Manager Botaneco, Northeastern United States

n Operations – Compounder FMI, Allentown, PA

n Principal Formulation Chemist Spartan Brands, Inc., New York, NY

n Technical Marketing Manager Amerilure, Inc., New Jersey

n Estée Lauder R&D Science and Engineering Summer Internship Program The Estée Lauder Companies, Melville, NY

n Senior Process Engineer The Estée Lauder Companies, Melville, NY

n Quality – Quality Technician FMI, Allentown, PA n Sales – Project Coordinator FMI, Allentown, PA

n Senior Product Development Chemist Straight Arrow Products, Inc., Bethlehem, PA V O L U M E

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