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Sunscreen Monograph Proposed New Rules and its Impact on Formulations

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Introduction

In February of 2019, the FDA stunned the cosmetics industry one more time by publishing proposed rules for sunscreens in the Federal Register.  As indicated by its name, these are only proposed rules but historically companies have implemented proposed rules into their formulations to be proactive.  The FDA used the argument that since the issuance of the original Final Monograph in 1999, the use of sunscreens and exposure to UV filters substantially increased.  It was important for the Agency to re-evaluate sunscreens based on current scientific understanding and extend safety assessments for such topical products to include chronic use.

 

What are the changes

The biggest change that the proposed ruling brought was the reduction of the number of Category I (Safe and effective) approved sunscreens that can be used in the US.  The FDA reduced the number of sunscreens in Category I from 16 to 2.  These two sunscreens are Titanium Dioxide and Zinc Oxide and they are approved at a level of 25% in formulations.  In addition, the FDA classified paminobenzoic acid (PABA) and Trolamine Salicylate as Category two II (Not safe and effective) which means that these two sunscreens can no longer be used in sunscreen formulations.  The remaining 12 sunscreens namely, Cinoxate, Dioxybenzone, Ensulizole, Homosalate, Meradimate, Octinoxate, Octisalate, Octocrylene, Padimate O., Sulisobenzone, Oxybenzone, and Avobenzone were classified as Category III (Additional data needed to confirm safety and efficacy).  These 12 sunscreens can be used in formulations until the FDA categorizes them into Category I or II.  From a formulation prospective, the FDA decreased the number of sunscreens to 14 until further action.  The FDA did not address the percentage at which those sunscreens can be used specifically, but probably a good fall back would be to use them at the levels published in the 1999 Monograph.  The proposed rule does not address the sunscreen active ingredients that are being evaluated under a TEA (Time and Extent Application).

In addition, the FDA proposed changes to the types of dosage forms that can be used for sunscreen products.  For Category I, they proposed the following dosage forms: oils, lotions, creams, gels, butters, pastes, ointments and sticks.  The FDA proposed Category I status for sprays subject to testing for inhalation and flammability.  Powders were classified as Category III pending additional data.  All additional dosage forms including wipes, shampoos, body washes, towelettes and others are considered as new drugs.

Broad spectrum testing was also changed.  In most parts of the world, the Critical Wavelength is used to measure broad spectrum.  The FDA is proposing to use the UVAI/UV ratio of 0.7 or higher as a standard for all sunscreens of SPF 15 or higher.  The FDA had previously proposed to make the ratio 0.9 or higher but realized that it is impossible to achieve such ratio with the portfolio of approved Category I sunscreens available in the US.  The new ratio seems reasonable but now manufacturers must perform two tests for global products, the UVAI/UV ratio and the Critical Wavelength.

Final formulation testing and labeling requirements have changed as well.  The FDA proposed to label products with the lowest SPF number achieved in in vivo testing to eliminate the variability associated with such testing.  The FDA also raised the maximum labeled sunscreen product to SPF 60+ and they attributed their decision to the lack of evidence that higher SPF product could bring meaningful clinical benefits.  The FDA proposed to label sunscreens products with an SPF 30 or higher in increments of 10 (i.e. SPF 30, 40, 50 and 60+).  They also proposed labeling sunscreens with SPF 15 to 29 to be in increments of 5 (i.e. SPF 15, 20, and 25).  The FDA also brought attention to products that are labeled SPF2 to SPF 14 and proposed that such products be removed from the market since they do not bring any adequate protection to consumers.

Sunscreens-insect repellant combination products are proposed to be classified as Category II due to incompatibility between FDA and EPA labeling instructions.  In addition, the FDA believes that combining DEET with certain sunscreens may increase cutaneous absorption of either or both.

 

What is the impact

In this proposed ruling, the FDA addressed so many safety concerns that companies and consumers suspected for years.  Many sunscreens used in the US are no longer used in Europe, Asia and the rest of the world due to their safety profiles.  However, these markets have alternative sunscreens in their portfolio that they can use to formulate safe and effective sunscreens.  In the US, such large portfolio of approved Category I sunscreen does not exist, so I would like to urge the FDA to speed the approval of all the molecules awaiting approval in the TEA process.  This will enable US formulators to have the same tools that their counterparts in the rest of the world have.  In the meantime, I am sure that formulators will use their creativity and start adapting their new formulations to the guidelines set forth by the FDA.

 

About the Author

Dr. Hani 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.

 

Development of Color Products – From William Perkin to Urban Decay

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Russian Red. 999. Ruby Woo. Pioneer. Androgyny. No. 1.

 


What do these words call to mind?

Beauty product enthusiasts the world over will recognize these iconic shade names currently inhabiting their purse. (The author tips her hat to the product developers and marketers at Dior, MAC, L’Oreal, Chanel, and Jeffree Star.)

At the risk of taking the technology for granted, what went into creating the iconic colors?

Accidental experiments, bold defiance, an enterprising mind, good taste, shrewd manufacturing, and hours of color matching in the product development laboratories.


A Short History Lesson: Accidental Chemistry Makes Mauve

In 1856 over Easter vacation, 18-year-old William Perkin set out to isolate quinine from coal tar. Perkin was student of great German organic chemist August Wilhelm von Hofmann at London’s Royal College of Chemistry. Quinine is a valuable compound with valued anti-malarial properties. However, any chemist who knows its chemical structure would not have attempted this approach. During Perkin’s time however, the structure of benzene was not even understood.

Chemical structure of quinine and benzene

Embarking on what some might call a fool’s errand, Perkin attempted to chemically isolate the compound. With an artist’s eye, he stumbled upon mauve instead, or “aniline purple”, through a series of serendipitous experiments.

Mere luck would not have been enough to produce entire libraries of color additives manufactured today. Against his professor’s recommendation –(proof that we should always make final judgement calls for ourselves rather than obey advice without discernment)– Perkin commercialized his discovery. With the financial support of his father, a construction contractor, he developed the processes for the production and use of the new aniline purple dye. In 1857, Perkin opened his factory at Greenford Green near London. From modest beginnings, the synthetic dye industry and its relative, the pharmaceutical industry, was born.

Despite falling short of his original goal (R&D scientists and research leaders: take note!), Perkin discovered the world’s first synthetic dye, opening up an entire chemical industry and painting the mass markets with bedazzling color.

Each time we swivel up a beloved tube of lipstick for application, we pay homage to Perkin. Our ability to make style statements with color products was enabled entirely by Perkin’s accidental discovery in 1856, shrewd manufacturing, and business development.

 

Color Additives for the Consumer Packaged Goods Industry

Perhaps the most tightly regulated in the cosmetic industry, these ingredients play an important role in making products visually appealing for consumers. With the right product, it empowers the consumer to make artistic statements of her choice through color products, unencumbered.

Modern day color additives have come a long way since 1856, and safely used for more than 150 years. Color additives are used to liven up a product. As industrial research brought science into industry, the industrial colorist was a profession that developed alongside industrial design after World War I. American designers and artists worked together on the design of tasteful and attractive goods to promote culture and civility to a nation that had become overwhelmed with unsophisticated immigrants from largely rural regions of southern and eastern Europe.

For manufacturers, the mass production of different colored goods posed other challenges. The need to predict which colored products would be attractive to the masses required market research, upkeep with Parisian fashion trends, and an understanding of consumer psychology. After World War II, the epicenter of mass market fashion moved to New York, where consumers exercised -and still very much do today- the power of choice over color for self-expression.

In broader contexts in business, color is used to liven a brand or company through its logo, to create instantaneous product recognition, set the visual tone and impression, or even influence consumer psychology. As such, judicious choice and use of color in products, advertisements, and on live consumer lips and faces, can pose as effective marketing campaign strategy to increase a company’s awareness and presence in the marketplace.

 

Judicious use of color even in a company logo can make a difference to a company’s brand, by igniting consumer emotion. Image source: https://www.fastcompany.com/3028378/what-your-logos-color-says-about-your-company-infographic

 

Technology Advancements Empowers the Consumer as Artist

Since the advent of brands like Urban Decay from the 1990s, bold colors have emerged on the cosmetic market, like a relentless catwalk and lightshow of color. Greens, blues, the blackest black, pinkest pink, and everything unicorn, iridescent, pearlescent, glow-in-the-dark, and in-between have become mainstays of any cosmetic product line aiming to market itself as exciting and cutting-edge.

 

Image source: www.urbandecay.com

Owing to technological advancements, consumers no longer have to choose between long-lastingness, comfort, payoff, or value. Oftentimes, a large palette of color options accost her, with the option of layering more than one color over her lips, eyelids, lashes, or face, to achieve her desired shade and look.

 

Less is More?

Presented with the sleuth of options, studies on the paradox of choice by Professors Barry Schwartz and Sheena Iyengar come to mind. While more isn’t always better, in the world of cosmetic products and beauty trends today, more DOES mean more. The wide array of color options delights the beauty consumer.

Today, this consumer is as complex in skin tone, gender, political association, and values, and expects her beauty products to reflect her multidimensional nuanced identity just as effectively. Variety in color and shade options (particularly in skin-matching tones for foundations) have been in long-time demand. Consumers asked, and beauty companies have listened.

The market today has made progress since the era of limited shade range housed in drugstore-branded compacts, where nary a tester was in sight for the consumer to choose a shade that matched her skin tone. “Nude” can mean many different shades. Brands such as Beauty Bakerie were founded upon this very premise of inclusion, turning shade names upon its head. Where brands used to start shade naming from light to dark, Beauty Bakerie makes it a point to call its darkest shade, “1”.

 

Jackie Aina, influencer known for pushing companies towards shade diversity and racial inclusivity. She demonstrates Too Faced’s pigmented emulsion foundation product in a range of new shades. Image source: https://www.glamour.com/story/jackie-aina-too-faced

 

Advent of Color via the Chemical Industry, Social Media, and Business

The evolution of consumer tastes tracks the ubiquitous use of social media and the rise of the beauty blogger voice,, both of which continue to drive demand volumes and trends today. Continued delivery of chemical and formulation innovation is what enables the fashionistas’ envelope-pushing on what is considered wearable and trendy. Contrapuntal to the international beauty companies’ main-stream product development approach, the rise of indie brands and the use of direct selling (e.g. Glossier) have sprung up to fill market whitespaces from the supply side. From the formulator’s standpoint, innovation has liberated what is possible in performance and payoff to meet the ever-growing consumer demands for “new”. Consumer force and industry innovation, very much lubricated by social media, has progressed hand in hand dramatically in the last decade.

The consumer voice has gained a significant amount of power in the beauty and consumer products industry today. The onslaught of small beauty brands has forced larger beauty conglomerates to innovate, push daring and imaginative color products, or buy up these small brands in an effort to be more competitive.

Development of technology by material suppliers continues to facilitate the creative explosion of color products. Raw ingredient suppliers in Europe, Asia, and the Americas push the boundaries of surface functionalization, particle, colloidal, material and formulation development, designing polymers and optimizing production capabilities to enable supply and production of novel raw ingredients. The advancement of technology and manufacture production has put high-performing value products directly into the consumers’ hands, democratizing beauty and lowering the cost of self-expression.

With the glut of products and trends, it remains to be seen where the push-pull conversation between consumer and company will take us. It is an exciting time to observe how raw ingredient suppliers and product development companies big and small will respond to market forces.

 

References

[1] https://www.sciencehistory.org/historical-profile/william-henry-perkin

[2] Rydzewski, R. M., Real World Drug Discovery

[3] https://www.sciencehistory.org/distillations/magazine/colors-run-riot

[4] https://medium.com/marketing-and-entrepreneurship/the-psychology-of-logo-color-in-how-consumers-view-your-brand-d3afe84f2bdb

[5] https://www.fastcompany.com/3028378/what-your-logos-color-says-about-your-company-infographic

[6] https://hbr.org/2006/06/more-isnt-always-better

[7] https://www.glamour.com/story/jackie-aina-too-faced

[8] https://www.wsj.com/articles/celebrities-like-kylie-jenner-are-upending-the-52-billion-beauty-industry-1543401001

[9] https://blogs.wsj.com/cmo/2015/06/09/bethany-mota-overtakes-michelle-phan-as-youtubes-top-beauty-producer/

[10]  https://www.huffingtonpost.co.uk/sophie-bianchi/beauty-bloggers-zoella_b_11566248.html

[11] https://www.wsj.com/articles/small-cosmetics-brands-make-over-the-beauty-market-by-targeting-millennials-11556296365

[12] https://www.wsj.com/articles/glossier-tops-billion-dollar-valuation-with-latest-funding-11552993200

 

About the Author

A polymer chemist in the personal care industry, Dr. Diane Lye is a product developer and formulator, translating novel raw materials into stable color, SPF, and skin care actives-containing consumer products. She studies the physicochemical properties of raw ingredients and finished formulas to map the consumer experience onto quantifiable entities.

Dr. Lye cut her fundamental scientific teeth by working on the design, synthesis, and bulk property characterization of main-chain block copolymer materials with supramolecular self-recognition end groups with the Weck Lab at the NYU Molecular Design Institute. She has 10 academic publications in her time in academic institutions, and developed a market commercialization assessment and plan for a dermal technology in conjunction with NYU Stern and NYU Langone.

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