Home News

News

NYSCC Participates American Chemical Society’s Middle-Atlantic Regional Meeting

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Giorgio Dell’Acqua chairs session featuring Moroccanoil’s Amber Evans, Coty’s Stacey House and other NYSCC executive board and scientific committee members.

The New York Society of Cosmetic Chemists (NYSCC) recently chaired a technical session on cosmetic chemistry during the 51st Middle-Atlantic Regional Meeting of American Chemical Society (ACS) hosted by its New York Chapter, St. John’s University and The Graduate Center of the City University of New York (CUNY).  This theme of the meeting was “Chemistry Refocused.” Held June 9-10,  it included technical and poster sessions on varied subjects within chemistry, employment programming, workshops as well as a graduate study fair, awards ceremony and more.

The cosmetic chemistry technical session was chaired by Giorgio Dell’Acqua (NYSCC) and attracted more than 75 participants between students and faculty members. It featured members of the NYSCC executive board and scientific committee that presented top cosmetic chemistry topics followed by a panel discussion on career paths in the industry.

Speakers and topics included:

• Dell’Acqua, NYSCC advisor and chief scientific officer, Nutrafol, spoke about “Sourcing and Developing Cosmetic Ingredients Using a Sustainable Approach.”
• Dr. Amber Evans, chair-elect NYSCC and senior manager of product development at Moroccanoil, spoke on “Hair Care & the Chemistry Within.”
• Stacey House, NYSCC chair, and senior VP of R&D consumer beauty, color and skin, Coty and LATAM, discussed “Decoding Ingredient Labels.”
• Dr. Hani Fares, senior director of skincare and oral care at Ashland Specialty Ingredients and chair of the NYSCC Scientific Committee, presented “Formulating Sunscreens.”
• Dr. Sue Feng, chief scientific officer, E.T. Browne’s global research and innovation, and NYSCC scientific committee member, covered, “How Textile Technology Innovations Transfer into Color Cosmetic Formulations.”

The technical session concluded with a panel Q&A on cosmetic chemistry career paths led by Dell’Acqua.

In addition, during MARM, NYSCC members coached students on their resumes during one-on-one review sessions, participated in a career panel with technical professionals from other industries, and engaged with students over their research posters.

“This was an exciting and fruitful outreach program for NYSCC this year. The Chapter will continue to foster relationships with other professional organizations and academia to promote cosmetic science as a strong career path,” said House.

SOFW.com – Interview with Giorgio Dell’Acqua, 2022 NYSCC Chair

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Interview with Giorgio Dell’Acqua, 2022 NYSCC Chair

Giorgio Dell’Acqua
2022 NYSCC Chair

Last November the Chapter successfully organized the first ‘back-in-person’ NYSCC Suppliers’ Day after the pandemic break. How was the turnout for attendees and exhibitors?

It was incredible and extremely rewarding to meet face-to face and be reunited with so many members and colleagues. This important event, November 10th and 11th in 2021, attracted 6,807 registrants and 392 exhibitors and they were all eager to find solutions and move forward in their businesses. Noteworthy were the international participants, from 30 countries, who were able to attend despite the travel restrictions.

At the conclusion of this Suppliers’ Day we also had a “Virtual Month of Beauty” that captured even more new registrants and fostered continued engagement.

A big shout to Susanna Fernandes, the 2021 NYSCC Chair, and the entire Suppliers’ Day team for navigating through such unfamiliar territory and being able to bring this edition of Suppliers’ Day to life!

What will the main focus of the 2022 NYSCC Suppliers’ Day on May 3-4, 2022?

The theme this year is “Your Destination for Science & Sustainable Sourcing Solutions.”  We are getting back to basics while viewing all chemistry and formulating through a sustainable lens. This will be evident on the exhibit floor and woven throughout the conference program. We will have subject matter experts in the field of digitalization, sustainability, clean beauty and advanced scientific testing, to name a few, presenting during the show and part of our comprehensive educational program.  All designed to inspire creativity, ingenuity, and innovation.

NYSCC also formed a Diversity & Inclusion Committee this year that will be involved in programming and activities at Suppliers’ Day to engage attendees in conversation about ideas that provide leadership in the cosmetics community around diversity and inclusion.

We cannot just be focused on the science of the ingredients and formulations without considering the impact of their sourcing both on the environment and society.

What can attendees expect this year?

As the only event in North America for ingredients, formulations, and delivery innovations, NYSCC Suppliers’ Day will have something for everyone.

It will be the best forum in North America for the latest trends, scientific findings, global ingredients, raw materials and solutions that will invigorate formulations and accelerate beauty and personal care product developments.

From end-to-end of the Javits Center, scientific and sustainable sourcing solutions that are impacting product development and brand creations will be discussed, experienced and on full display.

Suppliers’ Day this year will also feature 50+ individual conference sessions and curated educational programs, with 430+ exhibitors with more than 8,000 attendees expected to attend from all over the world.  Dynamic areas on the show floor, that once again is expanded into the D Hall at the Javits Center, will provide enhanced experiential learning including the classic Future Chemists Workshop, Presentation Theater, and the return of the INDIE 360 Pavilion. New this year will be a Poster Showcase, featuring the latest scientific findings and ingredients and formulation breakthroughs.

Suppliers’ Day for attendees will help catapult professional advancement and truly be non-stop learning, discovery, and business building.

What will be some highlights of the conference program?

NYSCC continues to grow and enhance the educational component of Suppliers’ Day.  This year we are excited to present our hallmark programs with updated content designed to help those involved in formulations, sourcing, and marketing beauty and personal care products achieve their business objectives including:

  • Discover Sustainability a series of quick but powerful presentations from leading companies that are successfully implementing clean beauty, green formulation, bio-based and cradle-to-cradle certifications, ethical sourcing, and more.
  • Digital Age of Beauty focusing on current strategies and innovations that influence product development, and speed to market. The latest digital tools and techniques that drive, measure and analyze consumer engagement and the demands they set forth will also be presented.
  • World of Chemistry delivering a global perspective and discussion on raw materials, solutions, formulation, and regulations.  Presenters encompass leading experts from countries and regions that are defining the beauty and personal care landscape.
  • Show Floor Presentation Theater complimentary to all attendees, provides insightful, leading-edge supplier presentations and interactive talks.

After last year’s success, INDIE 360 will return and we will be working with IBA (Independent Beauty Association) and other new partners on creating a program that focuses on every angle of the business.  A highlight will be brand founders sharing their candid stories and experiences as well as challenges, opportunities and pathways to success. There will also be a spotlight on how INDIE companies are utilizing unique ingredients or innovative ingredient combinations.

PCPC will also be back to present essential content on cosmetic regulation, safety assessment, and quality assurance.

The NYSCC Scientific Advisory Committee will present two conference sessions that take deep dives into topics that are relevant and timely to chemists and R&D teams and the pre-conference SCC CEP Courses will take place on May 2nd.

We also will continue our nurturing and support of the next generation of chemists with the expansion of our Mentor/Mentee Program and the Future Chemists Workshop with even more colleges and universities participating.  The co-sponsored SCC & NYSCC Career Development Day will also be part of the event

Of course we will also have our Industry Awards Night celebration after the first day of the show.  This year, the finalists of the CEW Beauty Creators Supplier’s Award will be revealed. Industry Awards Night is a great event for renewing partnerships and creating new ones and truly acknowledges the important drivers of innovation and exemplifies Suppliers’ Day core spirit.

Will the event be hybrid?

Yes we will offer a virtual day on May 9th. This will literally be an immersive experience with attendees feeling like they entered the Javits Convention Center in NYC and will give them a 360 degree view of the actual exhibits and expo floor from their desktops or mobile devices.

We also have a platform that makes it easy for exhibitors to provide the same assets and product information for both the live and virtual events and to even schedule appointments with the virtual attendees.

Some of the educational programs offered during the in-person Suppliers’ Day will also be available on May 9th.

Thank you very much for this interview and I hope to see many of your readers at Suppliers’ Day this year.  Please visit www.nyscc.org/suppliersday/ for more information and to register.

A new appreciation of scientific expertise

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Inteview with Giorgio Dell‘Acqua

Chairman, New York Society of ­Cosmetic Chemists

How has the coronavirus pandemic affected the work of chemists in the cosmetics industry?

The coronavirus pandemic has affected the role and work of cosmetic chemists in many different aspects. Chemists who were used to going to an office had to learn and adapt to working from home and away from their peers and colleagues. Those who worked in a lab were left in limbo at times waiting for their labs to reopen. And every chemist experienced supply chain disruption, ingredients shortages, as well as delays in manufacturing and shipping. Although our professional and personal lives were disrupted, I am proud and impressed how fellow cosmetic chemists and NYSCC Chapter members have adapted and grown during this unprecedented time.

There were some restrictions and delivery bottlenecks. What did the US have to contend with during this time?

The US have not only federal regulations but also state by state mandated regulations. This added a complex layer of restrictions and, depending on your state of business, dictated when you were allowed to go back to work and how – with some states requiring increased safety and hygienic protocols. There were some labs that were allowed to stay open with very limited disruption of business due to emergency status since they produced reagents and chemicals useful for fighting the pandemic. Delivery bottlenecks and supply chain issues were problematic for cosmetic chemists and their companies, especially if they were sourced from other countries. A localised supply chain became a good back-up plan for those in the industry.

To what extent have the customers’ requirements for cosmetic products changed during this time?

At the beginning of the pandemic there was a big demand for hand sanitisers and cleaning products. Once settling in, consumers started looking for products to increase their well-being and self-esteem due to the isolation and high stress level. Hydrating creams, hand creams, body creams but also products to achieve healthy nails and hair started to be in demand, as well as in-home care routines and DIY kits.

Also, Covid-19 did instil a new appreciation and respect for scientific expertise, and this was evident with consumers of beauty and personal care products. Consumers became more knowledgeable and informed about the ingredients and formulations used in creating and manufacturing the products they purchased.

What role does sustainability play and how does it affect the work of chemists?

Sustainability has been growing steadily as a key concept for the cosmetic industry for the past ten years. The recent pandemic has broadened sustainability to environmental protection and social equity issues. Consumers are demanding products and ingredients associated with a sustainability success story. Formulators are listening and developing products sourced though sustainability standards (including certifications and adhering to CSR guidelines).

What are the advantages and disadvantages of the natural ingredients that customers often demand?

Natural ingredients are centrepieces in current products and formulations and are often used to communicate the product itself. The main advantage and attraction of natural ingredients is that most consumers perceive them as safe. Natural ingredients have also been developed into active, standardised ingredients, with scientific claims and proven efficacy. Even if standardised, the main disadvantage of natural ingredients could be their long-term stability in a formulation. Also, their properties do not always match their synthetic counterpart as well as in a cost per use comparison.

What can so-called “green” or “clean” chemistry achieve here?

Green or clean chemistry and its twelve principles is a growing and significant trend for our industry. It is about environmental responsibility. It is being driven by consumers becoming increasingly conscious, better informed, and more concerned about the safety of product manufacturing and its impact to the environment. Once the synthetic process is optimised to reduce toxicity and waste and adopted on a large scale, it will be a game changer for us and the environment we live in.

“Chemistry is bad – natural is good” These or similar opinions are firmly anchored in the minds of many consumers. Why does “green” or “clean” chemistry play no role for end customers? Shouldn’t more educational work be done here?

There is misinformation in the beauty industry and consumers do get confused by erroneous crowd-source information about some chemicals and led astray by false marketing claims. However, with the rise of the clean beauty movement, and consumers increased interest in learning about the ingredients and the science behind it all, they are getting a better understanding that chemicals and naturals can safely be together in formulas and be effective.

What are the current trends in cosmetics?

Besides natural and clean beauty I see digitalisation, sustainability, customisation, holistic beauty, and the supplement market for beauty from the inside out as big trends. Also, hair care and products that combat stress related to hair loss will be big. There are also more products being developed for people identifying as non-binary and expanding the market in a very interesting way that is addressing people on an individual basis and putting our industry at the forefront of acceptance and inclusivity.

What is already demanded that may not yet be implemented now?

I think more technology in the green products category is needed as well asits increased accessibility. Scientific testing, which is so important needs to be more affordable so that all brands, no matter their size, can benefit.

What are current research topics?

There has been a big push on the use of artificial intelligence to develop solutions for consumers, both in product development, speed to market, and in testing. Also, new testing models for ingredients and products are being studied that mimic the clinical settings to facilitate scientific validation. Finally, the understanding of the effect of ingredients on the different mechanism in our body, as well as the interaction with the exposome and the microbiome is another interesting area of study and exploration.

Which trends will be showcased at NYSCC Suppliers’ Day 2022?

The theme for this year’s Suppliers’ Day, 3rd – 4th May in New York is the destination for science, sustainability, and sourcing solutions. This will be evident on the exhibit floor and woven throughout the conference program. NYSCC formed a diversity and inclusion committee that will be involved in programming and activities at Suppliers’ Day to engage all attendees in conversation about scientific ideas that provide leadership in the cosmetics community around diversity and inclusion.

We cannot just be focused on the science of the ingredients and formulations without considering the impact of their sourcing both on the environment and society.

Do Makeup and Skincare Products Really Expire?

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

People like to say that beauty doesn’t last forever, but the only time that’s really true is when you’re talking about your beauty products. Most skincare and makeup items have a shelf life because the preservatives in the formulas degrade over time.

“The ingredients evolve, and they’ll eventually go bad,” explains Giorgio Dell’Acqua, Ph.D., chair of the New York Society of Cosmetic Chemists. That’s why it’s important to clean out your beauty cabinet from time to time. That’ll protect you from potential infections and adverse skin reactions (plus it frees up room for new finds!).

Every time you dip your fingers into creams or use an applicator like (brushes and mascara wands) to apply makeup, the products get exposed to bacteria and fungi.

“Studies have shown significant growth of harmful microorganisms in cosmetic products—such as staphylococcus (a common bacteria that causes skin infections), and pseudomonas, which can cause skin rashes and abscess,” says Deborah Lee, a clinician in the UK who is also a medical writer for Dr Fox Online Pharmacy.

Preservatives prevent this growth, but when those start to break down, the bacteria and fungi can find a breeding ground, thanks to the products’ essential minerals, organic compounds, and high water content.

How to know when to throw away beauty products

Check the expiration date. If you remember when you bought a certain product, you can check the “Period After Opening” date on the ingredients label. Look for a tiny jar icon with a label such as ‘24M.’ That would indicate the product should be used within 24 months of opening.

Test your senses. “If you see a weird color, smell something funny, or feel that the texture has changed—toss it,” says Dell’Acqua.

Check up frequently. “It’s important to go through your makeup bag every six to twelve months and examine your makeup,” says Lee. In addition to giving you a chance to toss whatever has gone bad, it’ll help you better keep track of how long you’ve really had a particular product.

Ahead, learn more about the three common signs that signal a product has gone bad, plus how to keep your favorite beauty items clean.

Signs your beauty products have gone bad

The color is off.

Does your product look as good as it used to? “If the nice white and watery facial cream you bought a few months back now has a yellow color and looks oily—it’s time to get a new one,” says Dell’Acqua. Old foundations and concealers may appear more orange-y and skincare products that contain vitamin C may also turn a dark yellow color.

It smells weird.

Exposure to sunlight and warm temperatures encourage the growth of bacteria that leads to foul odors. Some products, like lipstick, may give off a chemical odor, while creams and moisturizers may have a sour or rancid smell. “Old mascara may smell like gasoline,” adds Lee.

“This happens a lot with sunscreen when people go to the beach,” says Dell’Acqua, but your bathroom can have the same effect. The Food and Drug Administration (FDA) also warns that bacteria thrive best in warm, moist, protein-rich environments and grow fastest in the temperature range between 41 and 135 degrees Fahrenheit. To prevent the growth of bacteria, try storing your makeup and skincare products in a clean, dry place, away from direct sunlight and moisture.

The texture changed.

As cosmetics and skincare age, their formula changes consistency. Many products will start to harden and crack. “You’ll begin to see separation in creams (and nail polish) because the water and oil molecules will break apart over time, causing the oil to rise to the surface,” explains Dell’Acqua. Mascara will become clumpy and dry, while lipstick may develop tiny holes or start feeling gooey or rubbery.

The general rule of thumb for discarding cosmetics after opening

  • Nail Polish: Two years
  • Powder foundations and eyeshadow: Two years
  • Liquid foundation and concealer: Six to twelve months
  • Lipstick, lip pencil, eyeliner pencil, and eyebrow gel: One year
  • Blush, bronzer, and face creams: One year
  • Lip gloss: Three to six months
  • Mascara and blending sponges: Three months
  • Facial moisturizers, eye creams, serums: Two years

How to clean your beauty products

Wash your makeup brushes frequently, clean the inside of nozzles, eyeliner tips, eye pencil sharpeners, and everything you regularly use that touches your face. “You should also keep your makeup kits, boxes, drawers, and compartments free of dirt and grime by cleaning it regularly with a cleansing wipe,” says Lee. This will help prevent bacteria from growing on or inside of your products. Below, check out a few derm-approved products you can use to clean and sanitize your beauty tools.

A Journey into Color Cosmetics and Lip Product Development

by james.runkle@drummondst.com james.runkle@drummondst.com No Comments

Introduction

The birth of color cosmetics is said to be traced back all the way to Mesopotamia over 5000 years ago where gems and semi-precious gems were ground up and applied to both the lips and the eyelids. In 4000 BCE, Egyptian women would apply Mesdement, a dark grey ore of lead, Galena chemically known as Lead Sulfide, and Malachite (bright blue green paste of Copper minerals) to color their faces for color. They also extracted color from seaweed, Iodine, and beetles to further add to their makeup palette. (1) Somewhere around 3000BCE women in in Greece applied a paste to their face consisting of white chalk, or lead, mixed in with crushed fruits such as Mulberries. They also used lipsticks comprised of clays mixed with red Iron.(1) During the Renaissance Era it was recorded that women use Arsenic in their face powders to replace lead and it wasn’t until the early 1800s that both of these were replaced by what is commonly known today as Zinc Oxide. In 1894 we saw the birth of what is known today as the PCPC, or Personal Care Products Council. Soon thereafter and beginning in the 1900’s the world saw a rapid increase in popularity of color cosmetics as well as the conception of many cosmetic companies commonly known today such as L’Oreal, Max Factor, Avon, and Maybelline to name a few. With this surge came new product forms such as hair dye, mascara, the first liquid nail polish, the powder compact, and in 1928, the very first lip gloss. In the 1940’s leg makeup was developed out of a need of necessity to fulfill the shortage in stockings due to World War II. Over the course of the next 60-70 years the beauty industry would experience a rapid growth spurt in not just technology but also in regulatory bodies that formed the very foundation for what our industry is today.

Color Ingredients

When we speak of color cosmetic formulations, the primary desired end benefit of these products is the same as it was thousands of years ago and that is to impart color to a part of the face to enhance one’s beauty and feel good about oneself. Whether it be a lipstick, foundation, concealer, eye shadow or pressed powder, the color additives are the main constituent and the base formula is what delivers the color and differentiates the product form. These color additives typically consist of pigments, lakes, dyes, and mica and their differences are explained below:

Pigments– Insoluble particles that impart a color to a product. Inorganic pigments are derived from minerals and have good stability to heat and light. Organic pigments, by nature, are carbon based and tend to have a brighter appearance to them. Commonly, pigments are often surface treated and sold in dispersions of various esters and oils to facilitate ease of use in manufacturing and ensure homogeneity of the color.

Lakes– Produced through precipitation of FD&C soluble dyes with metallic salts such as Aluminum salts. Lakes are useful to extend the color range of a shade palette. These ingredients are often surface treated and sold in dispersions of various esters and oils to facilitate ease of use in manufacturing

Dyes-Predominantly water-soluble, these ingredients are used in skin care, body care, fine fragrance, hair care, and color cosmetics. There are some dyes that are oil soluble as well.

Mica– A name given to a group of silicate materials that are used to add shimmer and sparkle

 

Even though all the ingredients above can be used across the broad category of color cosmetics from eye shadow and pressed powders to lipsticks and foundations, for the purposes of this article we will focus solely on the formulation of lipsticks and liquid lip products.

Physiology of the Lips

The physiology of the lips plays a key role when developing lip products. By nature, the lips are thinner than the skin on the rest of your body and therefore are more sensitive to changes in temperature and texture of a product. Therefore, comfortability and wear are 2 key product parameters that must be properly balanced during development. The lips also do not have hair follicles or oil glands and as a result of this are more prone to drying out especially in the winter months or in low humidity climates. As a result of this, key benefit claims such as hydration and intense moisturization are common for this product type. Finally, the lips do not contain melanocytes found in the skin and as such the color from the lips comes from the blood vessels directly under the surface of the lips.

During aging the lips begin to undergo biological changes like that around other parts of the face and body. The shape of the lips begins to become narrower and longer. They begin to lose volume and color overtime making them appear paler and less vibrant in color and the lines on the lip surface begin to deepen often causing the unwanted side effect of bleeding and feathering. Furthermore, they often present themselves with an unsmooth color tone and appearance.

Environmental exposure can also cause premature aging and thinning of the lips. Chronic UV exposure causes a breakdown in the collagen making the lips appear less full and voluminous. Dehydration from extreme weather conditions or poor health habits can lead to premature and undesirable chafing while exposure to environmental pollutants, i.e., free radicals, and smoking can lead to premature lip lines above the top lip.

Lip Product Formulation

Given the sensitivity of the lips and the desire to keep them young and vibrant looking there are multiple lip products out on the market today each with their own unique benefits and performance. Typically, colored lip products are found in 4 distinct anhydrous forms:

  1. Lipsticks
  2. Liquid Lipsticks
  3. Lip Gloss
  4. Lip Balms

Traditional lip formulations are composed of emollients, oils, waxes, and colorants with the ingredient ranges varying to deliver a stick or liquid format. Emollients/natural oils such Castor Oil, Lanolin, Shea Butter, are primarily used to help disperse colorants, while providing moisture and smooth application. Structuring agents such as Ozokerite, Polyethylene, and Carnauba and gellants are often used to give the sticks rigidity and stability while film formers are often utilized to improve the transfer resistance and wear properties. Benefit ingredients such as vitamins, natural oils, Hyaluronic acid, fragrance, etc. can all be added as well based on the target audience and desired claims.

In terms of finish, lip products typically are found in multiple styles ranging from matte, satin, pearl and shine with sheer to full coverage levels. From a performance perspective, today’s products are a great evolution to those from a century ago offering intense, continuous hydration, waterproof and transfer proof properties, SPF protection, and even all-day long wear.

Conclusion

Over the years the line between color cosmetics and skin care has become less defined. While the primary function of a color cosmetic is to provide color to the face, lips and eyes, the formulas themselves have become more technologically advanced and multi-faceted. Today’s products offer the consumer benefits beyond color such as anti-aging (wrinkle reduction), sun protection, anti-pollution, reduction of oily and acnegenic skin, minimization of scars, and even  tattoo and hyperpigmentation coverage. Additionally, companies continue to innovate in new color cosmetic product forms and test methodologies to deliver aesthetically pleasing, high performance products. For certain, this is a space that will continue to not only innovate but also adapt to today’s complex global challenges while pivoting to consumer needs for years to come!

References

  1. https://cosmeticsinfo.org/Ancient-history-cosmetics

 

Authors

 

Peter Konish has been in the industry for 25 years and is currently the Director of the Lip Category, Product Development and Innovation for Coty. Prior to this, he was the Global Director of Technical Operations in the Skin Health division of Johnson and Johnson. In this role Peter was responsible for Process Development, Packaging Development, and External Development/Innovation. Before moving to Technical operations, Peter spent 13 years at NeoStrata in Product Development overseeing the development of numerous Anti-Aging, Prestige Beauty, and Dermatological skin and body care. Peter also spent 9 years at L’Oreal in its Fine Fragrance division working on such brands as Ralph Lauren and Kiehl’s. Peter has a background in polymer chemistry, he has co-authored numerous book chapters and scientific publications, and has been an industry speaker at SCC events and annual AAD meetings.

 

 

Jeanine Smith has been in the industry for 19 years with her core focus in color cosmetics.  She is currently the Senior Manager of the Lip Category at Coty.  Prior to joining Coty, Jeanine was a Senior Manager at Avon Products where she worked in product development for the Eye, Nail and Lip categories.

 

The facts you need to know: new FDA proposed Sunscreen Regulation

by NYSCC NYSCC No Comments

Sunscreen Innovation Act

The Sunscreen Innovation Act sponsored by Jack Reed was introduced to the Senate Committee Health, Education, Labor and Pensions on March 13, 2014.  It amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.

FDA Proposes New Safety Testing for Selected Sun Filters

On February 26, 2019 the FDA published a proposed rule that would put into effect a final monograph for non-prescription OTC sunscreen drug products.  It establishes conditions under which certain OTC drugs may be marketed without approved new drug applications, indicating these products would be Generally Recognized as Safe and Effective (GRASE).  The sun care industry was hopeful that data previously submitted to the FDA would lead to the approval of additional sun filters currently used in Europe, under the FDA time and extent rule (TEA) policy.

Significance of the Proposed Safety Testing Protocol

To establish safety in use of sunscreen products, the FDA is proposing a Maximal Usage Trial study (MUsT). This is a human pharmacokinetic test that measures the amount of absorption of a drug into the body.  This study is new to the cosmetics industry and is more commonly used to study absorption of prescription drugs into the body.  The FDA believes this study will help to determine the potential effect of long-term use of an active ingredient.

 

Bio for Howard Epstein, Ph.D.

Howard Epstein is Director of Technical Services for EMD Performance Materials Corporation, Philadelphia, PA., an affiliate of Merck KGaA, Darmstadt, Germany. He was a scholar in residence at the University of Cincinnati department of dermatology and received his Ph.D. in Pharmacognasy from the Union Institute & University in Cincinnati, Ohio during that time. He has been in the cosmetics industry for many years since he began his career formulating cosmetics for Estee Lauder, Maybelline, Max Factor, Bausch & Lomb and Kao Brands. In addition to his interest in botanicals Howard previously served as editor of the Journal of the Society of Cosmetic Science and is a member of the International Academy of Dermatology. He is on the editorial board of the dermatological journals Clinics in
Dermatology and SKINmed representing the cosmetics industry to dermatologists.

Howard has authored chapters in various cosmetic technology textbooks including various chapters in Harry’s Cosmeticology, and holds eight patents and two patent applications.

Sunscreen Monograph Proposed New Rules and its Impact on Formulations-Part II

by NYSCC NYSCC No Comments

In my recent blog published in August, changes to the current sunscreen tentative monograph were proposed.  These changes are probably the most drastic changes to the sunscreen monograph since its inception.  In this section, I would like to tackle two key areas related to the changes requested by the FDA.  The first one is the human pharmacokinetics Maximal Usage Trial (MUsT) for sunscreens conducted by the FDA and published in the Journal of the American Medical Association in May 2019.  The second is the response from the Personal Care Product Council (PCPC) to the requests from the FDA for additional safety data.

The FDA conducted a MUsT trial on 4 sunscreen formulations.  The products consisted of 2 sprays, one lotion and one cream. A detailed description of the products used in the study and the sunscreens concentrations used is displayed in Table I below.

Table I

Concentrations of sunscreens in all treatments

Treatment Percent sunscreen contents per label
Avobenzone Oxybenzone Octocrylene Ecamsule
Spray 1 3.00 6.00 2.35 0.00
Spray 2 3.00 5.00 10.00 0.00
Lotion 3.00 4.00 6.00 0.00
Cream 2.00 0.00 10.00 2.00

Twenty-four subjects were enrolled in the study and were randomized into 4 groups.  Each treatment was studied on 6 individuals. All subjects finished the study except one.  Products were applied at a rate of 2 mg/cm2 on 75% of the body area.  Products were applied by a trained expert and were re-applied every 2 hours four times a day.  The study ran for 4 days and panelists were kept indoors.  Thirty blood samples were collected from each panelist over a period of 7 days and were analyzed for their concentration of sunscreens using a validated HPLC method.

Mean maximum plasma concentrations for all sunscreens were calculated for the four treatments and are displayed in Table II.

Table II

Geometric mean maximum plasma concentration for all treatments

Treatment Geometric Mean Maximum plasma concentration, ng/mL (%CV)
Avobenzone Oxybenzone Octocrylene Ecamsule
Spray 1 4.0 (60.9) 209.6 (66.8) 2.9 (102) Not applicable
Spray 2 3.4 (77.3) 194.9 (52.4) 7.8 (113.3) Not applicable
Lotion 4.3 (46.1) 169.3 (44.5) 5.7 (66.3) Not applicable
Cream 1.8 (32.1) Not applicable 5.7 (47.1) 1.5 (166.1)

As seen from the table, all sunscreens tested had higher blood levels than the FDA proposed threshold of 0.5 ng/mL.  These levels were also achieved on the first day of treatment.  The levels obtained triggered the FDA to request safety data not only on the sunscreens studied but also on the 12 sunscreens listed in the monograph.  In addition, the FDA requested MUsT studies to be conducted by the manufacturers on several dosage forms to establish proper guidelines for usage based on safety and efficacy.  Regardless of the results obtained, the FDA insisted on the fact that individuals should not refrain from using sunscreens.

In response to the request from the FDA, the PCPC sent a letter to describe the protocols and studies suggested by the council as well as a timeline.  The PCPC suggested to conduct, in addition to MUsT studies, several surveys on usage of sunscreen products to guide the council in designing the MUsT studies.  The timeline extends till 2023 which should give the industry some breathing room in terms of formulations.  Once the studies are received and completed, an additional timeline delineating the safety of the selected molecules will be proposed.  In the council’s response, two sunscreens were not considered for MUsT studies.  These are Cinoxate and Dioxybenzone.  The fate of these two sunscreens is not determined at this stage yet.

The sunscreen monograph has been evolving for the past 35 years to keep up with the advancement in science.  Formulators, and companies in the field of sun care will have to adjust one more time to the changes.  These changes bring a lot of new challenges and opportunities to innovate and lead.

 

Biography

Dr. Fares started his career in personal care studying the effect of solvents on sunscreen chemicals.  His interest in skin drug delivery especially from polymeric matrices grew during his graduate work at Rutgers, where he completed his Ph. D. in Pharmaceutics.

Dr. Fares worked at Block Drug and GlaxoSmithKline where he held positions in research and development in the areas of skincare and oral care.  After that, he joined L’Oreal where he held several positions of increasing responsibility leading to AVP of skincare.  He is currently the Senior Director of skincare and oral care at Ashland Specialty Ingredients.  Dr. Fares is the author of many publications, and patents and made many presentations in national and international meetings in the areas of suncare, skincare, and oral care.