How to Review R&D Bench Samples for Maximum Efficiency: A Guide for Clear, Constructive Feedback
When you’re partnering with a lab to create or refine your product, your feedback is one of the most powerful tools in shaping the final formula. Whether you’re evaluating a body butter, serum, cleanser, or balm, the way you describe what you’re experiencing is key to helping us fine-tune your formula to perfection. Yet, sometimes the words we use mean different things to different people. That’s why we’ve created this guide — to help you dissect each bench sample with clarity and confidence. Start by Setting the Scene When testing a new sample, try to replicate the real-life scenario in which your customers would use the product: Noting this context gives us better insight into how and why a formula may be performing a certain way. Core Sensory Attributes to Evaluate 1. Texture & Consistency (Before Application) Example: “This version feels stiffer and harder to scoop than our current butter.” 2. Application Experience (During Rub-In) Example: “It has a silky slip like a silicone primer — I like that. It feels luxurious.” 3. Absorption & Finish (Post Application) Example: “Leaves a nice cushion on the skin — protective but not sticky.” 4. Skin Feel (After 5–10 Minutes) Example: “It’s a little too occlusive — I’d like it to feel more breathable for summer.” Other Key Elements to Assess Emolliency How soft and moisturized does the skin feel after use?Terms: silky, plush, conditioned, rich, buttery Aroma Example: “This version is more floral — I’d like to dial it back to feel more neutral.” Appearance Color: natural / artificial / too pigmented / just rightTexture: smooth / whipped / grainy / uniform How to Give Great Feedback What do you like or dislike — and why?(“I like that it absorbs fast because I want it usable in humid climates.”) What would you change?(“Can we make it a bit less tacky without losing the moisturizing effect?”) How does it compare to your current product?(“Ours has more slip, this one has more drag — which makes it feel heavier.”) What’s the intended experience for your customer?(“I want them to feel instant relief and softness, but still be able to touch things without greasiness.”) Pro Tip: Use Benchmarking Language If possible, reference other products or your own existing product to describe your goals. For example:“I’m aiming for something like the feel of Brand X’s balm — but with a lighter scent.”“Think more butter than lotion — slow to absorb but super rich.” Let’s Get Specific Together Remember, terms like “greasy,” “light,” or “sticky” can mean different things to different people. When we dug into a client’s description of a sample being “too greasy,” we discovered what they really meant was it had too much slip. That insight led to big improvements — and a happy client. Bonus: A Sensory Vocabulary Cheat Sheet Attribute Descriptors Texture Thick, Thin, Gritty, Smooth, Whipped, Dense Application Slippery, Draggy, Spreadable, Slick Absorption Fast, Slow, Matte, Glossy, Dewy Afterfeel Tacky, Velvety, Oily, Soft, Cushioned Scent Floral, Herbal, Fruity, Earthy, Powdery Appearance Translucent, Creamy, Pigmented, Uniform Don’t Forget the Details Reference the sample batch number and version and keep them organized so that you can go back and refer to your samples specifically with your team. And, review your samples over a few weeks to see how they change over time. Formulas can thicken or thin, change color, all kinds of changes that you will want to be attuned to. Got a new batch of samples? Bookmark this guide and dive in. Your feedback is what makes our R&D process truly collaborative — and ultimately, more successful.
What to Expect When You’re Expecting a New Product Line
Launching a product? Buckle up. Creating a new personal care, OTC, or wellness product line is a lot like preparing for a baby. You’re picking names (hello, branding), assembling the nursery (packaging), meeting the pediatrician (your CMO), and yes, budgeting for diapers (raw materials aren’t cheap). It’s thrilling. It’s overwhelming. It’s not for the faint of heart. But with the right roadmap (hi, Tropical Labs!), it can be your most rewarding adventure yet. So before you jump on a call with our sales team and ask, “Can I launch by next month with a $2 unit cost and no packaging decided yet?” — let us walk you through what’s actually involved. Fun, friendly, and full of facts. Let’s go: 🧭 STAGE 1: So You Wanna Launch a Product… Before anything else, it’s crucial to understand the three primary ways you can launch a product — each offering different timelines, costs, and levels of customization. Here are 3 burning questions your Contract Manufacturer (CMO) will ask you right away: 🔢 1. What’s your MOQ? (Minimum Order Quantity)This is a biggie. Most CMOs won’t custom formulate under 5,000 units. Why? Because raw ingredients come with their own MOQs — and that lavender peptide active you love might only be sold in 20kg drums. We can sometimes go as low as 2,500 units at Tropical Labs, but it all depends on the formula, packaging, and other factors. It’s a discussion. 💰 2. What Product Category Are You In?Here’s a breakdown of skincare and cosmetics market categories from lowest price point to highest luxury, including common industry terms and real-world brand examples. These categories help define everything from price positioning to packaging expectations, retail channels, and customer perception: 📊 3. What’s Your Target COGS (Cost of Goods Sold)?What do you want your product to cost you — and how much do you plan to sell it for? COGS determines which ingredients, packaging, and manufacturing approach make the most sense. 💡 You may have a competitor with a low retail price — but they’re producing at massive volume. If you’re ordering 5,000 units and they’re making 500,000, your cost will be higher. Price accordingly. If you are good to go and ready to make a product… Here is the path forward and process to launch. ✅ Understand the Compliance of Your ProductBefore you start building your formula, know the regulatory framework your product must adhere to. Compliance is $$ and the more regulated your product is, the more $$ associated. Cosmetics — Regulated by MOCRA (Modernization of Cosmetics Regulation Act)💊 OTC (Over-The-Counter Drugs) — Regulated by FDA OTC Drug Monograph or NDA Pathway🥤 Ingestibles — Regulated under FDA Dietary Supplement Guidelines🐶 Pet Products — Regulation depends on claims and ingredients; see FDA Animal & Veterinary Guidance 🔨 STAGE 2: Pick Your Build Strategy Option 1: Private Label Stock Formulas from our library of proven and innovative formulas Option 2: Tweak a Stock Formula – add your “hero” ingredients Option 3: Full Custom Formula Option 4: Reverse Engineer a Formula 📦 STAGE 3: Packaging Ever heard the old saying, “Location, location, location” when it comes to real estate? In skincare, it’s packaging, packaging, packaging. Packaging isn’t just a bottle — it’s your first impression. It communicates your product’s identity, values, and price point before anyone even opens the cap. Lead times can delay your launch, so we prioritize packaging early. You can: 🎯 Know your demographic.Packaging should speak directly to your customer’s lifestyle and expectations: 🧪 Testing in packaging:If you want or need an expiration date, your product must go through stability testing in its final packaging. For OTCs, this includes 3 months of accelerated testing, plus up to 2 years of real-time data to confirm a shelf life claim. Your packaging is a chance to connect, educate, and emotionally inspire — before your customer even pops the cap. 🧫 STAGE 4: Formula Development & Confirmation If you’re going custom — either a full build or a tweak to a stock formula — this is your hands-on phase. Formula development typically takes 4–12 weeks from the time we finalize your manufacturing contract. 📌 Tracking your samples: Why tracking samples is important. You’ll likely evaluate several iterations. Clear documentation ensures that you and we are always referring to the same sample. This protects you and streamlines approvals. 📝 Always refer to the sample number and ship date when providing feedback or approvals. This keeps the process smooth and helps prevent costly errors or confusion. 🌺 STAGE 5: Fragrance Selection (Optional) Fragrance can be a powerful part of your brand identity. It plays a major role in how your customer feels about your product, even before it touches their skin. We can help you select or create the perfect fragrance to fit your vision. ✅ STAGE 6: Final Sample Approval Once you approve your final formula, you’ll sign an approval form that we keep in your project file. Nothing moves forward without this documented approval — it protects you and ensures complete accuracy. 🧪 STAGE 7: Stability Testing With your formula locked in, it’s time for a final chemist review and stability testing to ensure your product remains safe and effective over time. 🎨 STAGE 8: Artwork & Design Get ready to bring your brand to life visually! This is where your baby shines! IT’S ALL ABOUT THE BRANDING! 🧪 STAGE 9: Pre-Production Sample and Final Authorization Before we begin full production, we send you a pre-production sample showing exactly how your final product will look, feel, and perform. This is the time to make sure that your final product is everything you want. All the little details need to be reviewed and confirmed. ✅ Approval locks the project and the Bill of Materials (BOM) is created. Everything we do from this point forward ties back to the BOM. 📝 Two approvals are required — one from the client, and one from the CMO. Once both are in, we’re ready for your production order. 🛠️ **STAGE 10: Pilot Batch ** 🏭 STAGE 11: Full Manufacturing 🎉 Enjoy the Process — and Let’s Build Something Beautiful Together Launching a new product line in the personal care, OTC, or health and wellness space is a thrilling journey — a blend of excitement,
Skincare Product Manufacturer: The Art & Science of Passion Projects
Skincare is exploding in technology, innovation and sales. Anti-aging, functional nourishment, and wellness products are what it’s all about. Taking care of your skin is now starting at a very young age for both boys and girls, and men and women of all ages. Good skincare routines taught early are crucial in maintaining healthy and radiant skin and providing essential protection and nourishment. Behind every effective skincare solution is the expertise of manufacturers who blend art and science to create innovative formulas. These manufacturers are the driving force behind developing products that meet diverse skincare needs to ensure quality and efficacy in every drop. We will explore the process behind creating innovative skincare products, focusing on how skincare product manufacturers integrate research, clinical studies, evolving ingredients that push new and innovative products to market, creating excitement and spurring consumer trends. The Process of Creating Innovative Skincare Products Skincare product manufacturers follow these steps in developing high-quality products that meet consumer expectations and stand out in the market: 1. Market Research and Ideation The first step in creating innovative skincare products is understanding consumer needs. Manufacturers conduct surveys and focus groups and analyze market trends to identify consumers’ wants and needs. Additionally, competitor analysis helps identify gaps in the market that can be filled, providing opportunities for unique product development. 2. Research and Development (R&D) R&D is one of the most critical steps to true innovative formulas. Contacts and relationships with vendors and suppliers and constant communication about projects and advancements in materials is the driving force. Passion for what we do and the right R&D team of experts is crucial for discovering new and effective ingredients. Formulations are then developed to meet desired product specifications, such as texture and scent, while incorporating natural ingredients and scientific advancements. Stability testing ensures these formulations remain effective over time under various conditions. 3. Prototyping and Testing Once a formulation is developed, prototypes are created for testing. When a brand desires an additional avenue of differentiation, clinical trials are conducted with volunteers to assess the product’s safety and effectiveness. Exceptional results can later be used in marketing efforts. Consumer testing follows, gathering feedback from potential users to refine and improve the product before it goes to market. 4. Regulatory Compliance Safety assessments and regulatory compliance are essential to ensure that products meet legal standards. This includes toxicological evaluations and adhering to regional regulations. Accurate labeling is also crucial as it provides clear and honest information about the product’s contents. 5. Production Planning Production planning involves sourcing high-quality, sustainable ingredients and designing efficient manufacturing processes. Quality control measures are implemented at every stage to guarantee consistency and safety. Effective production planning is key to maintaining the integrity of the product as it scales from small batches to full-scale production. 6. Production During production, batches are scaled up while maintaining consistency in quality. Appropriate packaging is selected to preserve the product and attract consumers. Labels and branding elements are applied to align with marketing strategies and regulatory requirements to ensure the product is ready for distribution. Future Trends in Skincare Manufacturing Emerging trends and technologies in skincare product development include: Personalized Skincare: Advanced AI and data analytics are used to create customized skincare solutions based on individual skin types, concerns, and genetics. Clean Beauty: A growing demand for products with transparent, ethically sourced, and non-toxic ingredients leads to a focus on sustainability and natural formulations. Biotechnology and Advanced Ingredients: Innovations like lab-grown ingredients, peptides, and probiotics are being used to enhance product efficacy, targeting specific skin issues more effectively. Microbiome-friendly Products: As research into the skin microbiome expands, there is an increasing focus on developing products that support the skin’s natural ecosystem. Blue Light Protection: With increased screen time, products that protect against blue light emitted from digital devices are gaining traction. Sustainable Packaging: Eco-friendly packaging — such as recyclable, refillable, and biodegradable options — is becoming more common as brands aim to reduce environmental impact. Tropical Labs: Your Trusted Manufacturer for Superior Skincare Innovations Tropical Labs is a leader among skincare product manufacturers, seamlessly blending scientific research, natural ingredients, functional concepts and consumer insights to create highly effective products. As a rapidly growing contract manufacturer, we collaborate closely with clients to deliver innovative solutions that consistently exceed expectations. Our experienced team maintains the highest quality standards, ensuring excellence at every production stage. Contact us today for a creative and seamless partnership in developing top-tier skin care products!
Personal Care Product Manufacturing Innovation & Trends
The personal care product manufacturing industry is dynamic, constantly changing, and driven by consumer demand for high-quality and innovative products. This propels innovation in raw materials and science and technology to push all things into the now. Staying ahead of industry trends and technological advancements is crucial for manufacturers to meet these demands and maintain a competitive edge. This article explores the latest trends, cutting-edge technologies, and the comprehensive process of developing and producing personal care products. Industry Trends in Personal Care Product Manufacturing Here are the latest innovations in personal care products that highlight changing consumer demands and evolving approaches by manufacturers: Science-backed ingredients: Exosomes, stem cells, hydration in molecular sizes, peptides. Biotechnology: Advances in biotechnology have introduced sustainable ingredients and enhanced efficacy in personal care products. Bioengineered ingredients and plant-based alternatives reduce reliance on traditional resources and offer superior performance and safety. Upcycled materials: Using leftover or otherwise wasted ingredients to make skincare and cosmetic products, such as using less attractive bananas not sold in grocery stores for lip balm, or plum kernels to make a plum beauty oil. Natural and organic products: Consumers increasingly prefer natural and organic ingredients, leading to a rise in clean beauty products free from harmful chemicals. Sustainable and eco-friendly packaging: There is a growing emphasis on sustainability, with manufacturers adopting eco-friendly and refillable packaging solutions. Men’s grooming products: The men’s grooming market is expanding, with a wider range of products specifically designed for male consumers. Inclusive beauty: Companies are developing products that cater to a diverse range of skin tones, types, and needs. Clean and transparent labeling: There is a demand for transparency in product ingredients and sourcing, with consumers favoring brands that provide clear, honest labeling. Multifunctional products: Multifunctional products that combine several benefits, such as skincare products with SPF or makeup with skincare benefits, are becoming more popular. Ethical and Cruelty-Free Practices: Consumers increasingly demand ethically produced, cruelty-free products not tested on animals. Personal Care Product Technological Advancements Listed below are the technological advancements in personal care product manufacturing that have transformed the industry. Automation and Robotics Automation has revolutionized personal care product manufacturing by increasing production efficiency and reducing errors. Robotics has enabled precise handling of ingredients and packaging, ensuring consistent product quality while speeding up assembly lines. 3D Printing The rise of 3D printing has enabled customization in personal care products. It allows manufacturers to create intricate designs and shapes for packaging and even produce personalized skincare solutions tailored to individual needs. Artificial Intelligence and Machine Learning AI and machine learning technologies are pivotal because they can analyze consumer data, predict trends, and optimize formulations. These technologies enhance product development by providing insights into consumer preferences and improving quality-control processes. Internet of Things (IoT) IoT devices transform manufacturing by monitoring equipment and environmental conditions in real time. They also facilitate smart manufacturing processes that streamline operations and minimize downtime. Biotechnology Advances in biotechnology have introduced sustainable ingredients and enhanced efficacy in personal care products. Bioengineered ingredients and plant-based alternatives reduce reliance on traditional resources and offer superior performance and safety. Digitalization and Consumer Engagement Digital technologies, including digital twins and consumer-facing apps, enhance personal care manufacturing and consumer engagement. Virtual simulations optimize production processes, while digital platforms offer personalized product recommendations and interactive experiences. End-to-End Process of Product Development and Production These are the steps involved in developing and producing personal care products, along with the challenges associated with meeting consumer demands and regulatory standards: 1. Research and Development (R&D) R&D begins by researching consumer preferences and market trends, formulating products, and conducting safety tests. During innovation, it is critical to balance natural ingredient demands with regulatory requirements and manage costs and timelines. 2. Testing and Safety Assessment Products undergo rigorous safety testing, including allergen checks and compliance with global regulations like FDA or EU standards. Ensuring product effectiveness while meeting safety requirements is crucial for maintaining compliance and consumer trust. 3. Manufacturing and Production Scaling production involves sourcing raw materials, establishing manufacturing processes, and implementing quality control measures. Key challenges include maintaining consistent product quality across batches, adhering to Good Manufacturing Practices, and improving processes for cost-effectiveness. 4. Packaging and Labeling Creating packaging that meets regulatory standards, protects the product, and ensures accurate labeling is essential. It is important to balance the need for eco-friendly packaging with product protection while complying with various global labeling regulations. 5. Distribution and Logistics Once manufactured, efficient logistics are crucial for timely product delivery and quality control across global distribution networks. Navigating import and export regulations and effectively managing distribution channels are ongoing logistical challenges. 6. Marketing and Consumer Engagement Effective marketing strategies help to position products, communicate benefits, and engage consumers through various channels. Key goals include adapting strategies to diverse consumer preferences, maintaining brand integrity under review, and gathering feedback for product improvement. Tropical Labs: Your Partner in Exceptional Personal Care Innovations At Tropical Labs, we blend science, technology, and nature to create personal care products that exceed expectations. Our team of in-house chemists and lab technicians brings years of experience and innovative ideas to transform your vision into a successful brand! With a steadfast commitment to quality, we ensure all our formulations undergo rigorous testing to guarantee safety and effectiveness. Contact us today to begin your journey with confidence and precision.
Contract Cosmetic Manufacturer: Insights for Your Brand
Contract Cosmetic Manufacturer: A Behind-the-Scenes Look at Tropical Labs CD3MO approach. Most people, even key players with brands that work frequently and seamlessly with their skincare and beauty contract manufacturers, do not know all that is involved to get a product to market. We love to tell the story about our internal mapping board which we use to pull each project through — from the start of RFQ all the way to finished and approved pre-production samples, and then into the validation process. We scroll left to right on the mapping board and for all the steps involved, it goes and goes and goes…. It is intense! Every detail must be completed. From R&D and formulating to specifications and package compatibility, sourcing and procurement, compliance, regulatory, receiving specifications, storage, production, validations, testing, and then shipping. Tropical Labs has taken this process to the next level with its CD3MO approach. The contract cosmetic manufacturer has a vital role in the beauty industry, managing the formulation and production of high-quality cosmetics for various brands. They enable companies to focus on marketing and sales by handling the intricate manufacturing processes. It’s crucial for brands to understand what happens behind the scenes, the precision and complexity involved in contract cosmetic manufacturing, so that they can engage more effectively with their manufacturer. This article delves into how contract cosmetic manufacturers utilize their capabilities and strategies to address product formulation and market trends. We will also explore the challenges and innovative solutions they implement to overcome them. Manufacturing Capabilities of Contract Cosmetic Manufacturers Here are the comprehensive capabilities of contract cosmetic manufacturers that deliver high-quality and innovative products: Comprehensive Product Development: Research and Development Tropical Labs is an innovation launching pad for beauty care brands. From simple to complex product development, we have the R&D talent and a proven, thorough process, leading to truly unique and efficacious products. Our advanced laboratories and scientific teams create innovative formulations tailored to client needs. Additionally, we engage in prototyping and testing to guarantee efficacy before the final product reaches the market. Large-Scale Production Tropical Labs is equipped to handle large-scale production to accommodate different client needs. We utilize automated production lines to ensure consistency in manufacturing processes. Scalability is another capability that allows us to adjust production volumes in response to market demand, whether for small or large batches. Small Scale Production Some of our largest clients initially came to us for small scale production needs. Since launching their first products, they have grown with us into thriving skincare companies. Even large brands want the opportunity to do small product launches for new products. Having the ability for small scale development and production is one thing that sets Tropical Labs apart. Quality Assurance and Control Contract cosmetic manufacturers adhere to stringent industry standards and certifications such as GMP and ISO. They also have in-house laboratories for regular quality checks and comply with safety regulations. Additionally, traceability systems track production from raw materials to distribution, guaranteeing consistent quality. Tropical Labs checks all of these boxes. Packaging and Labeling Contract manufacturers like Tropical Labs offer creative and functional packaging solutions that resonate with market preferences. They also provide sustainable packaging options to address environmental concerns. Additionally, Tropical Labs ensures all packaging meets regulatory requirements and aligns with their clients’ branding needs. Supply Chain Management Tropical Labs secures and ethically sources raw materials through a reliable supply chain. We also maintain efficient and detailed inventory management to avoid shortages, ensure timely production, and avoid waste. Key Strategies To Meet the Market Demands Listed below are the strategies employed by cosmetic manufacturers to stay competitive with market demands: Continuous innovation: A contract cosmetic manufacturer stays ahead in product formulation by incorporating cutting-edge ingredients and sustainable practices to guarantee competitiveness and environmental responsibility. Consumer-centric approach: Extensive market research and feedback mechanisms enable contract manufacturers to tailor products to consumer needs, offering personalized solutions for enhanced effectiveness and appeal. Strategic partnerships: Collaboration with research institutions, experts, and clients facilitates innovation and market responsiveness, while global networks provide access to diverse markets and resources for overall growth. Innovative Solutions to Manufacturing Challenges Contract manufacturing is not always smooth sailing. As with other industries, there are challenges and considerations that have to be addressed. But, in our view, this simply brings out our best thinking, which leads to extraordinary products. Some of the most common challenges we see in cosmetic manufacturing are outlined below. Regulatory Compliance and International Standards Manufacturers must navigate complex regulations to make sure their products are safe and compliant with all legal requirements. This can be challenging when dealing with multiple markets, each with its own rules and standards. To address this, Tropical Labs invests in advanced compliance systems and software that help streamline the process of meeting legal and regulatory requirements. Managing Supply Chain Complexities Disruptions in the supply chain, such as shortages of key ingredients or logistical delays, can impact production schedules and product availability. At Tropical Labs, we employ just-in-time inventory practices to reduce waste. Additionally, advanced logistics technologies track shipments and optimize delivery routes. Guaranteeing Consistency and Quality Across Batches Variations in raw materials and production processes can lead to inconsistencies in the final product. To ensure consistency and quality, Tropical Labs uses advanced quality control techniques such as real-time monitoring, automation, and AI-driven analytics. These technologies help detect and address variations in production processes. Intellectual Property and Confidentiality Concerns A contract cosmetic manufacturer must safeguard proprietary formulations, processes, and designs against unauthorized use or disclosure, which can be challenging in a highly collaborative environment. To protect information, Tropical Labs employs robust IP protections, including non-disclosure agreements, patents, and trademarks. We also invest in secure data management to protect sensitive information. Choose Tropical Labs As Your Expert Contract Cosmetic Manufacturer! Tropical Labs is your premier choice for a reliable contract cosmetic manufacturer. Committed to surpassing your expectations, we leverage our expertise, dedication, and creative flair to excel in cosmetic production. Partner with us for a seamless experience, where
Health SKIN DEEP: Holistic, Functional and Wellness Skincare
It used to be that all that mattered in cosmetic or skincare formulation was a headliner “hero” ingredient that would enable companies to create buzz and cash in on the latest fad. Today, consumers are becoming much too savvy for that to work. They know what they want, and that’s clean, beneficial products without the junk. We believe this is an irreversible trend, rather than a fleeting fad that will be gone next year. The world of cosmetic skincare has transitioned into health and wellness with true efficacious benefits. Raw material companies are regularly launching innovative, healing, and beneficial raw materials, including complex blends that are making a huge difference for formulators and, ultimately, the end user. Tropical Labs is uniquely positioned to support brands seeking to offer the cleanest, most innovative skincare products. This is not merely aspirational, or a clever marketing spin. We have specialists who dig deep to find answers and develop amazing products, much more than traditional formulations. For our high level clients, we offer one of the best genomic consultations in the world during the R&D process. This enables us to translate health and wellness needs into topical and ingestible products that will offer true benefits to the majority of people. For example, synthetic vitamins typically clog the liver, so using natural vitamins in formulations delivers maximum health and wellness benefit. Or for another example, tumeric has become a widely popular ingredient for anti-inflammation, but did you know that it’s not as bioavailable in the body without a delivery uptake like black pepper extract? Skincare and haircare are the next areas to conquer. Understanding that scientists have established a gut-skin axis, you tend to notice and think about how that translates into product formulation, both internal and external. The Tropical Labs team includes a formulation specialist, genomist and R&D Director who work symbiotically together and lwho understands how ingredients work within the DNA and genome pathways throughout the body, for good or ill. This helps us focus on the good and reject the bad. We’re not merely guessing at what could work, but applying our expertise to develop amazing, beneficial products that are as close to the Socrates saying “Let food be thy medicine and medicine be thy food”. We challenged ourselves to find the answers and we found great clients along the way who are eager to pioneer exciting ideas in this space. Working with our clients, Tropical Labs has created beautiful, clean, healing products. I’m excited about where we are going in this frontier of health and wellness. And this is only the beginning! When it all comes together, it’s a beautiful product!
What Does it Take: Going to Market with a Custom OTC (Over-the-Counter) vs. a Cosmetic?
R&D Formulations Most people think of Over-the-Counter (OTC) as cough syrup or something you can buy from the drugstore without a prescription. While that is true, it can also refer to drugs and other products with “medicinal” ingredients. A few examples of OTC products are decongestants, topicals that relieve itches, and treatments for common bodily aches, like Tylenol. But, most people don’t think of sunscreen, hand sanitizer, or eczema lotion as being an OTC product, much less a “drug.” At Tropical Labs, we receive many inquiries for OTC products, with sunscreen being one of the most common requests and one of the harder custom formulas to bring to market in terms of expense, compliance, and time involved. OTC custom formula manufacturing is neither viable for small quantity orders (less than 5000 units), nor for fast product launches. If you have been yearning to develop and launch the next innovative OTC product, read on. This article will walk you through Tropical Labs’ process of R&D formulations for OTC products. Our goal is to give you a clear understanding of the expense, development time, and regulations associated with OTC product development. The good news is: With our multi-decade experience, Tropical Labs can help you stay fully compliant while also avoiding the OTC pitfalls that can snare you. What is an OTC? It’s pretty simple: If you make a claim on your label, it must follow rules and regulations set forth by the Food and Drug Administration (FDA) for OTC products. You may think you have the next best eczema lotion, but even just calling your product an “eczema lotion” is a claim. What about an SPF30 lotion? With this product, you are claiming that it will protect against sunburn according to the parameters set forth by the FDA for SPF30. Hand sanitizer? Your claim is that it kills germs. In short, if there is a claim, there is a path of compliance you have to follow, or you risk drawing the attention of the FDA or the Federal Trade Commission (FTC). Making OTC Claims When advertising OTC products to target markets, manufacturers create claims describing the functions, applications, and ingredients the items contain. OTC product claims have to be substantiated by the FDA monograph. This means, you can only claim what the monograph allows for. If you marketed, even if true, claims that were not covered under the monograph, they would be considered misbranded by the FDA. If you have ingredients that you think are the “cure” or efficacious for an ailment, the easiest way to bring a new formula to market and make that “claim” is to add the ingredients in the inactive ingredient section and select a standard monograph active. For example, Eczema has a monograph for salicylic acid.If you have essential oils that you think are the key to the cure, you would add them in the inactive ingredients but use the monograph for salicylic acid as an active, to make the claim for Eczema relief. We have often had clients report amazing discoveries with a combination of natural ingredients and they want to “claim” and report the success of their anecdotal evidence, but they cannot. Even if, for example, rosemary extract grew back hair, you would not be able to make this claim without finding a monograph that already exists and is approved for the claim of hair regrowth. There are three ways to safely make product claims: 1. HARD: New Drug Application (NDA) If a company wants to base a claim on a new, raw material or new formulation, they will have to prove to the FDA that the formula or ingredients work as described. This process is very expensive, time consuming, and is closely related to what pharmaceutical companies go through to bring a drug to market. 2. EASY: Follow The FDA Monograph (https://dps.fda.gov/omuf) The FDA has a list of ingredients that they consider viable for making a claim. When you follow the monograph, you can make a claim; just be sure to file your National Drug Code (NDC) number. If you follow a monograph, you will pick an “active material” already approved by the FDA when used in the formula at the percentage required by the FDA. In other words, a monograph is a predetermined product “recipe” that, when followed, the FDA allows companies to make the established claim tied to that recipe, and that the product is safe and effective enough to be sold over the counter. Adhering to the FDA guidance means you can safely make a claim for the given active material. Many times, new and innovative ingredients are “hidden” as inactive ingredients because to use the new ingredient as an “active” would cause the (now new) formula to fall out of the parameters of the monograph. In such a case, the product would have to be filed as an NDA. 3. EASY: Follow Cosmetic Claims Cosmetic claims are not the same as OTC claims. Cosmetics are typically defined as intended for external use (skin, hair, lips, nails), or perhaps related to teeth, with an exclusive focus on cleaning, perfuming, changing appearance, correcting odors, or protecting. Cosmetics claims typically involve a temporary effect imparted by the product. Any claims related to treating or preventing disease would make the product a drug and therefore subject to FDA regulation. The short list of cosmetics claims that can be made are: OTC “Drug Facts” Label The “Drug Facts” label on OTC products provides information, directions, warnings, and approved OTC product use. The FDA regulates OTC manufacturers to observe the following format in creating “Drug Facts” labels: Additionally, the “Drug Facts” label will fall under a monograph claim by FDA. As mentioned above, OTC products must be FDA-registered with a National Drug Code (NDC) number. OTC R&D Formulation Process Through the R&D formulation process, Tropical Labs makes product development a breeze for our clients — from formulating and packaging compatibility, to stability and full compliance and regulatory review. We combine science, technology, and nature to