Formulating skin care products requires a cross-disciplinary knowledge base that is hard to obtain and master. It can be a daunting, time-consuming, and costly process when skin care product formulas fail or run into legal issues. This article provides a useful and easy to understand primer on legal language as well as essential tips on how to formulate an effective, safe, and legal skin care product.

Regulation Guidelines
First, it’s critical to be well-informed on the legalities of formulating skin care products. Cosmetic products and ingredients, other than color additives, do not require pre-market approval by the U.S. FDA. However, laws that apply to cosmetics on the market may vary from state to state (interstate commerce).

The two most important laws pertaining to cosmetics marketed in the U.S. are the Federal Food, Drug, and Cosmetic Act (FD&C) and the Fair Packaging and Labeling Act (FPLA). The FD&C defines cosmetics by their intended use as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance.” The products that fit this definition include perfumes, lipsticks, nail polishes, eye and face makeup, shampoo, hair dyes, and deodorants.

Claims
It’s very important to be informed about various claims that should be noted for labeling or describing cosmetic products. If the product is intended for a therapeutic use, such as preventing or treating disease, or changes the effects or functionality of the body, then it is considered a drug. Products intended to make individuals more attractive are considered cosmetics. For example, the word “moisturizing” is a cosmetic claim. If the goal of a product is intended to make fine lines and wrinkles to appear less noticeable by moisturizing the skin, then it’s cosmetic. Similarly, “primers” intended to make the signs of aging less noticeable by hiding them is also considered cosmetic.

Products that are intended to affect the structure or function of the body, such as the skin, are considered drugs or sometimes medical devices, even if they affect the appearance of skin. For example, if a product is intended to remove wrinkles or increase the production of collagen in the skin, then it is considered a drug or a medical device.

Good Manufacturing Practices
Good Manufacturing Practices (GMPs) constitute specific guidelines that should be followed when developing skin care products. If a company manufactures skin care products, the risk of misbranding cosmetics or contamination is reduced by following GMP guidelines.

Under these guidelines, buildings and facilities used for manufacturing should be of suitable construction, design, size, and maintained in a clean and orderly manner. Equipment used should be of appropriate design, size, and material for the intended purpose in order to prevent contamination. Defective equipment should be removed and suitable tools should be calibrated regularly and checked according to standard operating procedures (SOP) with results documented.

Personnel in charge of supervising or manufacturing skin care products should have the required education, experience, and training to perform assigned duties. Personnel should adhere to the necessary protective clothing guidelines when coming in direct contact with cosmetic raw materials, in-process materials, finished products, or contact surfaces. Eating food, drinking beverages, or using tobacco should be restricted to appropriately designated areas, away from processing and storage areas.

To ensure raw materials are safe and to fulfill their intended purpose, they should be handled and stored to prevent mistakes (misidentification and selection errors), contamination with chemicals or microorganisms, and degradation from exposure to harsh environmental conditions (cold, heat, moisture, sunlight). Raw materials should be held in closed containers and stored off the floor, labeled with identity, lot number, and control status (quarantine or release). Regular testing will ensure the safety and identification of any contaminants in the sample.

Documents
Material Safety Data Sheets (MSDS): A document that provides vital information on the potential hazards of a chemical product and how to work safely with the chemical product. It also contains information on the handling, storage, usage, and emergency procedures all related to the hazards of the product.

Standard Operating Procedures (SOP): A procedure specific to your operation that describes the activities necessary to complete tasks in accordance with industry laws, regulations, or even standards for running your own business. Any document that is a “how to” falls into the category of procedures. In a manufacturing environment, the most important example of an SOP is the step-by-step product line procedures used to make products as well as train personnel.

SOPs are standards and policies needed in the administration, marketing, and operation within a business to ensure success. They can create:

• Efficiencies and therefore profitability;
• Consistency and reliability in service and production;
• Reduced errors in all areas;
• Guidelines on how to resolve conflicts between partners;
• Healthy and safe work environment;
• Production of personnel in areas of potential liability;
• Roadmap of how to resolve issues and troubleshooting;
• Value added to the business.

How to Formulate Effective Skin Care Products
Here’s the exciting part of the article: how to formulate an effective skin care product like a pro. It can be daunting to design and formulate products from scratch, which can lead to wasted time and money on failed products. The following is a list of important steps for formulating skin care products with confidence.

1. Formulary Target
Determining your formulary target is the first and most important step. The questions a formulator should be addressing include:

• Who would the product be created for (e.g., sensitive skin)?
• What’s the problem or need that should be resolved (e.g., wrinkles)?
• What are the benefits you would want your product to have (e.g., moisturize dry skin)?
• What are the aesthetics (feel and look) of the product (e.g., promote soft skin)?

Answering these questions will help select the best ingredients to create a product that consumers will enjoy and reap effective benefits. The formulator will produce a product that addresses their problems, delivering desired and long-lasting results.

2. Know Percentages
Formulations are written in percentages rather than in cups, grams, ounces, or other measurements. This promotes accuracy and consistency, easily creating batches of various sizes (small to large) depending on how much of the desired product is needed.

3. Understand Ingredient Percentage Ranges
When deciding on what type of finished product to produce (e.g., balms, soaps, lotion, etc.), it is necessary to know the percentage ranges to be used for each ingredient category. For example, to create a lotion, 3-6% emulsifying wax is used; to create a body wash, a surfactant blend will be around 25-30% of the formulation. It is necessary for the formulator to understand how each ingredient affects the finished product to determine how much is safe to use.

4. Starting Formula
A good template will list various ingredients and the percentage ranges at which to use them, giving the formulator freedom to edit based on the information collected in the product development process. Certain products need specific ingredients at precise ranges in order for them to mix well and be effective.

5. Preservatives
It is essential to add a preservative to prevent microbes from growing in the finished product. Preservatives stop growth or kill bacteria by making the product an unviable environment in which to grow. If a product contains water or an aqueous solution (e.g., hydrosols, milk, aloe vera, floral water, etc.) or will come into direct contact with water (e.g., facial scrub using wet fingers) a broad-spectrum preservative is required. For an anhydrous (without water) product or scrub, if the product is used in a humid environment or introduced to water, a preservative is recommended. When using a water-soluble preservative in an oil-based product, an emulsifier should be added to allow for proper mixing of the preservative and oil.

To ensure the product is sufficiently preserved, challenge tests or preservative efficiency tests are used. Microorganisms are introduced into the product on day 1 with a re-challenge at day 21. This is performed on a mixed culture of organisms (gram-negative, gram-positive, yeast, and mold) and the total test period is 28 days with plating counts running on 0-28 days. The preservative will pass if it demonstrates the ability to kill the introduced microorganisms, and retains its activity at the 21-day re-challenge. A control sample without a preservative must be run and discarded, as it will fail the test.

There are important factors that will help increase the effectiveness of the preservative:

• Reducing the amount of water;
• Minimizing energy for microorganisms to grow (e.g., botanicals, fruit, tea, lecithin, etc.);
• PH (antifungal preservative at a low pH or an antibacterial preservative at a very high pH);
• Using GMP guidelines;
• Adding 0.2% disodium EDTA into the heated phase;
• Using deionized, distilled or purified water;
• Checking to see if the preservative is a broad-spectrum blend.

6. Calculating Surfactants
Skin care products like shampoos, shower gels, and facial cleansers contain at least two surfactants to make the formulations mild and effective. Surfactants that are usually sold by suppliers are diluted, so it can be difficult to know how much surfactant is in a formula and whether the amount falls within the required range for the skin and product type. Percentages are adjusted based on the mildness of the chosen surfactant. Other ingredients in the formulation can impact the active matter and the mildness of the product. Here are the surfactant percentages for specific skin care products:

• Facial cleansers made up of mild surfactants contain around 8-10% total active matter;
• Body washes and shower gels contain 15-20% total active matter.

7. Ingredients
There are many skin health ingredients on the market. The following is just a sample of some of the latest and popular ingredients and their beneficial effects on the skin.

• Silicon (Bamboo extract): Prized ingredient in many beauty products for its ability to strengthen hair, skin, and nails. Rich in antioxidants, bamboo extract has been shown to slow aging and preserve youthfulness in the skin.
• Hyaluronic acid (HA): A key ingredient in various anti-aging formulas, HA has been shown to hydrate the skin to provide a plump and youthful appearance.
• Grape skin extract: Contains a healthy level of flavonoids, which have been shown to increase the synthesis of collagen, elastin, and HA in the skin, which are key components to providing youthful-looking skin.
• L-Ascorbic acid: The only form of vitamin C to use and look for in a skin care product, L-Ascorbic acid stimulates the synthesis of collagen, reducing fine lines, scars, and wrinkles.
• Alpha-Lipoic acid: Potent antioxidant that helps repair past skin damage.

When assessing whether an active ingredient is beneficial in the targeted formulation, the formulator should answer the following questions:

• Will the active ingredient penetrate the stratum corneum, delivering appropriate concentrations to the intended target in the skin over a timeframe that’s consistent with its function?
• Does the active ingredient have a specific action in the targeted cell or tissue?
• Are there any credible and peer-reviewed clinical trials to validate the efficacy claims?

Answering these questions will ensure the formulator uses the appropriate ingredients and tools needed to develop a skin care product intended for a targeted goal.

Final Thoughts
In the pursuit of healthy skin, it is advisable to remember that skin care products can be a complex combination of ingredients and measurements. Achieving basic knowledge of formulary and legal language can go a long way to helping formulators develop a skin care product that’s safe and effective. n

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About the author: Dr. Krystal Crawford, ND, MS, is a naturopathic doctor who graduated from the University of Bridgeport’s College of Naturopathic Medicine and Nutrition Institute, where she received her Doctorate in Naturopathic Medicine and Master of Science in Human Nutrition. She has a practice in the Rochester, NY area.