Yes the FDA defines a cosmetic 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" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

The FDA does not perform product testing. They do require that you produce a safe cosmetic. It is up to you to ensure that your product is safe. Lab testing is your responsibility.

If the products you produce are regulated by the FDA, it is not required that you register your business with the FDA. They do have a voluntary registration program for businesses. You can read about this on their website Click Here.

Lotions are emulsifications of oil and water that contain at least 70% water. Creams are emulsifications of oil and water that contain at least 70% oil. Ointments typically contain over 80% oil.

Most lotions have a pH between 4 and 5.

Your label should include:

Front: Product name and, positioned close to the bottom, amount of product in fluid ounces with the amount in milliliters in parentheses. For example, a 2 ounce bottle would be “2 fl. Ounces (56.4 mL).”

Back: Instructions for use, followed by the ingredients in INCI (International Nomenclature of the Cosmetic Industry) format, then your business name, then the physical address of manufacturing, if your business is not listed publicly, such as in the phone book. If your business IS listed, then city, state and ZIP is all that’s required. Other information, such as your website, email address or phone number are optional.

There are many other requirements for a lotion label. You can view all of requirements with examples at the FDA Website – Click Here.

The FDA aggressively regulates sunscreens. They are considered to be a drug and requires premarket testing and research. FDA drug testing is a rather lengthy and very expensive process.

The FDA clearly states that you are legally responsible for making a safe cosmetic. The only way to know a lotion “from scratch” is safe is to have it lab challenge tested.

A lab challenge test takes 30 days and is done by a trained professional. I am unaware of any “do it yourself” kit that performs a true lab challenge test.

Cosmetics need not be sterile, however, they must not be contaminated with microorganisms which may be pathogenic, and the density of non-pathogenic microorganisms should be low. In addition, cosmetics should remain in this condition when used by consumers. Each cosmetic should be tested for adequacy of preservation against microbial contamination which may occur under reasonably foreseeable conditions of consumer use. This is called a challenge test.

Most of our formulas are luxurious blends of emulsified oils and water.

There are some products on the market called “creators”. Most often these are silicates and act as a suspending type agent. You will know if you are working with a base such as this because when heated it will not become liquid. If you are using a base such as this, you will want to keep it in an airtight container because it can dehydrate and shrivel to a small percentage of its original size.

Emulsified means the mixture of two or more un-blendable liquids. One liquid is dispersed in the other liquid. Lotions can be oil/water which means there is more water in the formula or they can be water/oil which means there is more oil in the formula. Emulsification is the process by which emulsions are prepared.

Each formula is completely different. The result is many different bases to meet the needs of a variety of customers.

Crafter’s Choice Goat Milk & Honey gets the biggest thumbs up from Debbie.

Crafter’s Choice Lotion Bases have been formulated and preserved with the expectation that fragrance and color will be incorporated. You do not need to add additional preservatives.

Vitamin E is an excellent antioxidant. You can incorporate it into the lotion at 0.25-.5% of the total formula. Before you add Vitamin E to the base, make sure it has not already been added. It will be listed as Tocopherol on the ingredient label.

The water you added broke the emulsion. At this point, the lotion cannot be saved and should be discarded.

The best way to thin the base is to preserve distilled water…as directed by the preservative of choice. Then add this preserved water to the ready to use base. Incorporate with a mixer until the desired consistency is achieved.

If you chose to incorporate water, there are two important points to remember. First, you are now creating a totally new product and will need to have proper testing done to ensure your formula is properly preserved. Two, there is no guarantee that the new “water heavy” mixture will stay emulsified. Overtime, the water may separate from the oil.

The most popular colors used are Crafter’s Choice Liquid Dyes. They easily incorporate and create beautiful colors. Also popular are the Crafter’s Choice Liquid Lakes and Crafter’s Choice Fluorescent Dyes. You will find that sparkle micas will only work well if large amounts are added to the lotion….even at that point you will not get a huge sparkle until the lotion dries on the skin.

Try adding 0.25-.05% preserved water to thin the base. This small amount should not break the emulsion.

Ready to Use lotion bases are formulated with enough preservative for the base itself, color and fragrance.

Adding additional oils becomes quite complicated because the preservatives in the lotion are not designed to handle large volumes of unpreserved additives. We do not recommend adding oils to a “Ready to Use” lotion base. If you wish to customize a lotion with additional oils we recommend making a lotion base from scratch.

Some lotions may thin with the addition of water. You will need to preserve the water prior to adding it to the lotion. Not all “Ready to Use” lotion bases have enough emulsifying agents to handle additional water. You will need to test your formula and observe for water/oil/wax separation.

Most lotions have water very high on the ingredient list. You will not need to list water a second time. If you are concerned that the additional water will change the hierarchy of ingredients, please contact us with your formula so we can pull our proprietary formula and verify your modified ingredient label.

For most of the Crafter’s Choice Lotion Bases, you would list this just prior to the preservative listing on the ingredient list. If you are unsure, you can call us to verify. We are working on an ingredient label tool that will give you this information without calling our offices. Look for this to be available early 2010.

The FDA states that the designated color INCI name can go at the end of the ingredient list.

The FDA clearly states that you are solely responsible for producing a safe cosmetic and in this case we are talking about lotions. All Crafter’s Choice Lotion Bases are produced and packaged in an FDA inspected facility. All bases have passed independent lab challenge tests and testing during the manufacturing process. They have been formulated and lab challenge tested to stay preserved with the addition of fragrance and color only, assuming you are following Good Manufacturing Guidelines by using clean equipment.

If you are incorporating additional water, oils or other additives we highly recommend that you have your formula lab challenge tested.

Look for all WSP FREE Recipes to be challenge tested in 2010. It is our desire to take on the expense so that you know your formulas are safe.

There is no one set formula for lotion. Different lotion formulas will give you different results. For example, just changing the amount of water and the amount of oil can make the difference between a lotion and a cream.

Corn starch can help eliminate some of the greasy after touch. Isopropyl Myristate is a clear additive that is also a popular additive for eliminating a greasy after touch.

Prepare a clean workspace. Gather your ingredients and measure ahead of time. Set aside the emulsifier, fragrance and preservative. In one container, combine your oil based ingredients. In a separate container, combine your water based ingredients. Heat your oil based ingredients on low heat. Heat the emulsifier and any waxes until liquified. Add the emulsifier and waxes to the heated oils. Heat the water based ingredients. Combine all heated ingredients. Using a mixer, traditional blender or stick blender begin to mix. Once ingredients begin to cool they will emulsify. Allow the lotion to cool until 120º F. Add fragrance. Allow the lotion to cool to a temperature that allows for incorporation of the preservative. Pour lotion into containers. Leave container top off until product has thickened and returned to room temperature. Apply cap and label.

Preservatives are limited to different applications. Check out the WSP website for exact percentages to be used and exact application. The following is the maximum manufacturing temperature.

Germaben II – 140º F
Germaben II E – 140º F
LiquaPar – Lowest Possible
LiquaPar Optima – 176º
Phenonip – No Restrictions
Germall Plus Liquid – 122º F
Optiphen Plus – 176º F

Unfortunately, it is not possible to produce an all natural lotion with no preservatives. Lotions contain water. Yeast, bacteria and fungus grow in unpreserved water. Water-based products, such as lotions need to contain a broad-spectrum preservative suitable for the formula.

For lotions, the best two are Germaben II and Germall Plus. Used at their recommended rates, they provide excellent protection against the growth of mold, fungi and bacteria. Keep in mind, though, that these preservatives make up a very small percentage of your product.

The entire formula needs to be preserved.

No. These are antioxidants. Antioxidants slow down the growth of free radicals in oils, which make them turn rancid. They don’t provide any protection against the growth of mold, fungi or bacteria.

Grapefruit Seed Extract (GSE) once had the reputation of acting as a preservative. In researching this issue we found that there was a company selling GSE with an added undisclosed preservative. When people saw that their lotions were passing lab challenge tests with the GSE they assumed GSE was a preservative. Since then, the company has removed the preservative and to our knowledge the products do not pass lab challenge tests.