Cosmetic Color Additives

Only approved color additives may be used in cosmetic products.
This article applies to the United States, but most other countries have similar laws

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When it comes to cosmetics, the term color additive is defined in the law.1 It is:

• A material that is a dye, pigment, or other substance made by synthesis or a similar process; OR
• A substance that is capable of imparting color to a cosmetic or to any part of the human body.

It is important to note that the additive could be a natural or synthetic substance; could be derived from any animal, vegetable, mineral, or other source; or could be the result of a reaction between two or more compounds. Needless to say, it is a very broad definition — the key is that the substance is a dye or pigment OR it is capable of changing the color of a PRODUCT or the HUMAN BODY.

Examples of color additives:

• A dye, such as an FD&C or D&C color.
• A pigment, such as an iron oxide or an ultramarine.
• Activated charcoal as an ingredient in soap can change the soap's color – therefore activated charcoal is a color additive.2

When a substance is added to a product for some reason other than changing the color but it also changes the color as a side effect, is it still a color additive unless the resulting color is not at all important to the appearance, value, marketability, or consumer acceptability of the product.3

FDA Responsibility for Color Additives

The FDA has a specific mandate to verify the safety of any color additive before it may be used in food, drugs, cosmetics, or medical devices. Once the FDA has determined a color additive is safe, regulations are issued that specify the technical description of the color additive and any limitations or restrictions on how or where it can be used. Once approved and regulations are issued, the color is sometimes referred to as a "listed color.”

There are separate color additive lists for foods, drugs, cosmetics, and medical devices. For example, a color additive may be approved for drugs but not cosmetics, or for cosmetics but not foods.

Certified Colors

Some color additives must have each batch tested and certified by the FDA before they can be sold for use in cosmetic products. These are often called "certified colors” but were originally called "coal-tar dyes” because they were produced as a byproduct of coal processing. Now they are considered "synthetic-organic colors” (but are still synthesized from coal or petroleum products). You can normally recognize them by their names, which are prefaced by "FD&C” (Food Drug & Cosmetic) or D&C (Drug & Cosmetic) followed by the color number.

Examples:

• D&C Yellow No. 8
• FD&C Red No. 40

Exempt Colors

Other color additives are exempt from batch certification by FDA but may still have specific specifications that must be met in order to be legally used in cosmetics. These are mostly plant, animal, or mineral derived (but may also be synthetic). Regardless of their source, they are still considered artificial colors because they are used to artificially and intentionally change the color of the product.

Examples:

• Mica (mineral)
• Ultramarines (synthetic)
• Iron Oxides (mineral)
• Annatto (plant)
• Carmine (animal)

For both certified and exempt-from-certification color additives, the manufacturer is responsible for ensuring that they are appropriately certified (if applicable) and that any required specifications are met.

Only Approved Color Additives

The law prohibits selling an adulterated cosmetic.7

Several of the ways the that a cosmetic can be adulterated (and therefore prohibited from being sold) pertain to color additives:8

1. You can only use approved color additives in cosmetic products.
   
   A cosmetic is adulterated if it contains an unapproved color additive.
   
   Example: An herb, plant, or spice that was added to a cosmetic product to change the color, but which is not an approved color additive, such as paprika used to make a cosmetic soap orange or powdered sage to make a soap green.
2. You can only use an approved color additive in the way it is authorized for use.
   
   A cosmetic is adulterated if it contains an approved color additive that is used in a way for which it wasn't authorized.
   
   Example: A lipstick that is colored with a color additive that is not approved for use on the lips, such as Red 31 or purple ultramarines.
3. You can only use an approved color additive that meets the required standards and specifications.
   
   A cosmetic is adulterated if it contains a color additive that does not meet the required standards and specifications.
   
   Example: Using mica that is larger than 149 microns (the maximum size allowed per the specifications for mica) as a cosmetic color additive.
4. You can only use a certified color when it has been batch certified by the FDA.
   
   A cosmetic is adulterated when it contains a color additive that should have batch certification by the FDA but does not.
   
   Example: Pigment Red 57 (also known as CI and Red No 201) is the same chemical compound as D&C Red 6. Once a batch of Pigment Red 57 has been tested and certified by the FDA it is called D&C Red 6 and may be used in cosmetics.

Uses, Limitations & Restrictions

When initially approving a color additive for use in cosmetics, limitations or restrictions may be set on its use. There are three main usage designations:

• General use
• External use only
• Eye area use

General Use

Color additives approved for general use may be used in cosmetics that are generally used, including lip products. They may not be used in the eye area unless they have been specifically approved for eye area use.10

External Use Only

Color additives for external use may be used in cosmetics that are only applied to external parts of the body, but not to any body surface covered by mucous membrane, which includes lips, inside of the eyelids, inside ears, nose, and mouth, or the genitals.9

External use cosmetics may not be used in the eye area unless specifically approved for eye area use.10

In-Bath Products: When a color additive is used in an in-bath product, the color may infuse into the water and could come in contact with mucous membranes or the genital area. The FDA has determined that color additives that are approved for external application may be used in in-bath products because there is limited potential for exposure.

Eye Area Use

Color additives must be specifically approved for use in the eye area. Even if the color additive is approved for general or external use, it cannot be used around the eye area unless the FDA has specifically approved it as safe for use near the eyes. 10

The eye area is defined as the whole area between the top and bottom bones around the eye, including the eyebrow, skin below the eyebrow, eyelids and eyelashes, the eyeball and the sac holding it, and the soft tissue that is around and under the eye. 11

Eye Area: the whole area between the top and bottom bones around the eye

If a product is intended to be used around the eyes and contains a color additive that is not approved for eye area use, the product is adulterated and prohibited from being sold or introduced for sale.

Blended Colors

Color additives are frequently blended together by suppliers to create a variety of different colors. Occasionally the blends will include ingredients that are not color additives but are used for a different purpose. These are most commonly synthetic mica (correct name "synthetic fluorphlogopite”12) and tin oxide.

Colored Mica

Mica is a mineral which is whitish or translucent. It has no real color itself but may have a small amount of sparkle. Colored micas are sold as colorants for soap and cosmetics. These are actually blends of mica and some other color additives.

Glitter and Pearlescent Colors

Most glitter and pearlescent (shimmer) colors, when not made with mica, are made with a plastic which is colored and cut into fine pieces. When it is very important that you know the actual color additives used to make the glitter. See Color Additives: Glitter. [link to upcoming article]

Restrictions and Limitations

Your supplier should provide you with a list of the ingredients in the blended color and tell you how the color additives in it may be used. All the rules that apply to how a color additive may be used apply to the components in a blended color.

Special Situations

Hair Dye may contain unapproved coal-tar dyes under very specific circumstances. See Color Additives: Hair Dye [link to upcoming article].

If you want to learn more, please visit our website Additives for ETICS.

Tattoo ink and permanent makeup are considered cosmetics, but there aren't any color additives that are approved for injection into the skin.13 It's one of those FDA anomalies.

Theatrical & Halloween soap and cosmetics (including face makeup) are still subject to the same regulations as normal, everyday cosmetic products when it comes to color additives. There is only one glow-in-the-dark color additive approved for use in cosmetics (luminescent zinc sulfide). There are limited fluorescent colors approved for use in cosmetics (Orange 5, 10, and 11; and Red 21, 22, 27, and 28). There are also limitations on how these may be used.

Ingredient Declaration

Color additives may be placed at the end of the ingredient declaration regardless of the amount of the color additive.14

Certified color additives should be identified by just the color and the number (i.e. "Red 31” or "Yellow 8”).

Non-certified colors should be identified by their official name (i.e. "ultramarines” or "annatto”). For ultramarines and iron oxides don't use the color associated with it (for example, use "ultramarines” not "purple ultramarine”).

When a blended color additive is used, all of the approved color additives may be placed at the end of the ingredient declaration. However, any non-color additives that are in the blend should be placed in the correct order with the non-color ingredients in the ingredient declaration.

Synthetic oil is a lubricant made up of artificially made chemical compounds; these compounds are made by breaking down and then rebuilding petroleum molecules.

What Is Synthetic Oil?

Synthetic oil is a lubricant made up of artificially made chemical compounds; these compounds are made by breaking down and then rebuilding petroleum molecules. Under a microscope, a drop of synthetic oil shows millions of molecules all nearly the same size and structure. Conversely, mineral or conventional oil is made using refined crude oil. A drop of conventional oil under a microscope shows millions of molecules all with different shapes, sizes and structures. Synthetic oil can be fully synthetic or a synthetic blend and be derived from multiple base types.

Full synthetic oils use a synthetic base stock, are uniquely designed molecule by molecule without using petroleum and include additives meant to help the degradation of the oil. A synthetic blend is a mix of conventional motor oil and synthetic base stocks. Adding the synthetic base stock to the conventional mineral oil gives you a little bit more protection than just using the conventional oil by itself.

There are multiple types of synthetics with distinctly different properties and applications. However, most synthetics used in automotive service are polyalphaolefins (PAO). For simplicity, the primary reference to synthetic oils in this article will relate to PAOs.

Synthetic vs. Conventional Oil

Most vehicles are capable of using either synthetic or conventional mineral oil that meet the American Petroleum Institute's (API) and International Lubricant Standardization and Advisory Committee (ILSAC) specifications. However, synthetic oils are often marketed as having superior performance when compared with conventional oil. This superior performance may only relate to certain properties but not others. It is possible that some formulations of conventional mineral oils may exhibit superior performance on certain properties.

There have been numerous studies over the years comparing synthetic oil to conventional mineral oil. Most notably the American Automobile Association (AAA) used certified labs using American Society for Testing and Materials (ASTM) standardized test methods to examine differences in engine oils marketed as conventional versus those marketed as full synthetic.

Among other things, AAA found that, on average, synthetic oils outperformed conventional oils by 47 percent in the conducted tests. The selected tests evaluated several important physical, chemical and performance properties including shear stability, deposit formation, volatility, cold-temperature pumpability, oxidation resistance, and oxidation-induced rheological (viscosity) changes.

Synthetic oil is quickly becoming the new normal, with nearly 70 percent of new cars in the model year getting either fully synthetic or a synthetic blend oil, according to Consumer Reports. Even as the number of new cars requiring synthetics continues to increase, it remains important for consumers to follow manufacturer recommendations for their vehicle when it comes to changing their oil. "Semi- or full-synthetic oils are required for most newer cars, but it is vital that the automaker's recommendations be followed, or accelerated engine wear and other problems could result," Michael Calkins, Technical Services Manager for AAA tells Machinery Lubrication.

The advancement of synthetic oil has put the microscope on conventional oil. Even though conventional oil lubricates your car's engine adequately in most cases, there are some possible disadvantages to using it. These disadvantages may or may not be realized or noticed depending on various factors like marginal fluidity at extremely low temperatures, thermal and oxidative stability (prolonged chemical stability at high temperatures) and viscosity protection (against wear and friction) at high engine loads and temperatures.

Advantages and Disadvantages of Synthetic Oil

So, what are the advantages of switching to a synthetic as opposed to a conventional motor oil? When looking at the pros and cons, synthetic lubricants can offer meaningful advantages. The following are some of the most significant advantages synthetics (PAOs) generally have over conventional engine oils. Note, the list below assumes that the additive package would be similar between the two options which is rarely the case. Most synthetic lubricant formulations for automobiles would have a superior additive package making the comparison more complex. In other words, is the superior performance the result of the synthetic base oil or is it due to the superior additive(s) or a little of both?

• When exposed to certain conditions, conventional mineral oils are usually more prone to chemical degradation (oxidation) compared to synthetics. These harmful conditions include combustion byproducts, fuel contamination, water contamination, metal particles, acids, pro-oxidants and extreme heat (e.g., from combustion). Exposure to these conditions commonly occur in engines. Oil degradation can cause sludge, varnish or deposits, corrosion, viscosity change and impaired engine performance.
• Synthetics have a naturally higher viscosity index. This means the viscosity changes less (more stable) as temperature changes during normal engine startup and operating conditions. Viscosity is an important property of lubricants that produces the film thickness or clearance between metal surfaces that slide or rotate against each other. Without this film thickness, excessive friction and wear would occur.
• At extremely low temperatures, it is more possible for mineral oils(compared to synthetics) to become so thick (high viscosity) that the oil is unpumpable or is unable to circulate effectively within the engine. Lack of oil circulation can cause lubricant starvation conditions and engine failure.
• Synthetic engine oils are generally less volatile than mineral oils. This means there is less loss of the oil to the engine's exhaust stream causing atmospheric pollution. This could also mean less need for makeup oil between oil changes.
• Possibly the biggest advantage and the reason synthetic oil is so popular, is that it has a longer lifespan than conventional oil. The recommended change interval for synthetic oil is around every 5,000 to 7,000 miles, with some brands touting a much longer interval (15,000 to 25,000). The biggest reason for the longer oil change interval is described in the first bullet above. Regardless of the kind of oil you use, it is still recommended to change your oil at regular intervals recommended by your manufacturer.

A few disadvantages of synthetic oil to be aware of include:

• Probably the most glaring downside of synthetic oil is the cost. The price of synthetic oil is around two to four times the price of conventional oil.
• Synthetics may be more prone to additives precipitation during cold storage conditions. This stratifies certain additives which can potentially lead to their complete separation from the oil.
• Multi-grade motor oils using synthetics may exhibit slightly less fuel economy at highway speeds compared to mineral oil. This is due to the fact that mineral oils require more viscosity index improvers (an additive) than synthetics. This additive contributes to reduced viscosity friction by a mechanism known as shear-induced temporary viscosity thinning.

Advantages and Disadvantages of Synthetic Oil Advantages Disadvantages Resistant to oxidation and chemical degradation More expensive Withstands temperature extremes better (cold and hot) Possible additive precipitation/separation Flows better at cold temperatures Slightly lower fuel economy at highway speed May produce less sludge and surface deposits Longer oil change intervals More robust film thickness at higher temperature and higher loads

Is Synthetic Oil Worth the Cost?

When it comes to the price of synthetic or synthetic blends, it's not always black and white. "It is very difficult to generalize because of the many differences in oil brands and formulations. A quart of modern semi- or full-synthetic oil usually costs somewhere between four and 10 dollars, although some special blends can cost even more," Calkins explains.

As of , five quarts of conventional oil costs approximately $28 and an oil change with conventional oil costs about $38, according to a survey of AAA's approved auto repair facilities. Conversely, five quarts of full synthetic oil will set you back about $45, while an oil change with full synthetic oil costs about $70. This means switching from conventional to synthetic will cost the average driver about $64 per year or $5.33 per month.

While a manufacturer-approved conventional oil won't harm your engine in any way, forking over the extra $30 per month and switching to a synthetic oil could save you money long-term in the way of protecting your engine's components over time. You may also make up for some of the extra costs by changing your oil less frequently.

When it comes to the cost of an oil change, the change frequency of synthetic oil is longer, with most brands recommending an oil change at around 5,000 to 7,000 miles (up to 25,000 miles depending on some brands). Conventional oil changes are recommended at anywhere from 3,000 to 5,000 miles. It's important to note, if you're going to use a synthetic oil for longer oil change intervals, you should upgrade your oil filter to one also with a longer service life to match that of the synthetic oil.

So, is synthetic oil better for your engine than conventional mineral oil? "In general, yes – provided the automaker's viscosity grade and other oil requirements are adhered to," says Calkins. While mineral oil does provide adequate lubrication for your vehicle's engine, synthetic oil better protects your engine through the use of higher-quality, more refined base oils.

"Always use at least the type of oil recommended by your vehicle's manufacturer. If your car only calls for conventional oil, the slightly higher cost of a semi-synthetic product will provide better engine protection. Regardless of the oil used, always follow the vehicle manufacturers' recommended oil change intervals," says Calkins.

Additionally, think about how long you plan to own your car. Investing in premium lubrication may slightly extend the life of your engine; However, if you are planning to sell your car long before engine failure is likely with mineral oil, the benefit of using expensive synthetics is transferred to the next owner of your car. In other words, you paid for expensive oil but gained minimal benefit during the time you owned the car.

It should be said there are certain exceptions to this concept. One in particular is exposing an engine to worst case scenarios long before their normal end of life. Worst case scenarios include extreme temperatures, forgetting to change the oil on schedule, heavy loads, frequent cold starts, frequent short commutes, impaired engine cooling, etc.

Synthetic Engine Oils: Digging Deeper

Synthetic oil used in motor vehicles is refined from base oils or base stock oils. The American Petroleum Institute (API) categorizes base oils into five categories; the first three are oils refined from petroleum crude oil. Group IV base oils are fully synthetic, and Group V contains all base oils not in the first four groups. The API identifies two of the most common base oils used for synthetic oil as Polyalphaolefins (PAOs) and Esters (Diester and Polyol).

• PAOs are the most common type of synthetic base oils used today thanks to their moderate price and little negative attributes. PAOs are Group IV base oils and are similar to mineral oil in their chemical makeup but the fact that it's built rather than extracted makes it purer. The benefits of PAOs include improved oxidation and thermal stability, low volatility (potential to change rapidly), good heat dissipation, low pour point (temperature below which a liquid loses the ability to flow) and it's free of waxy molecules.
• Esters- a Group V base oil made from ester oils is created from the reaction of acids and alcohols with water molecules splitting off. The most common esters used for synthetic motor oil are diesters and polyol esters. Diesters are commonly used as an additive with PAO base stock oil. Esters have high thermal stability and excellent low pour point characteristics but poor hydrolytic stability (the resistance of a cured polymer material to going back to a semisolid or liquid form when exposed to high temperatures and humidity).

Synthetic Option Advantages Disadvantages Poly Ester or Diester
(Group V) Highest VI, Lowest Pour Point, Highest Thermal Stability May not be suitable where moisture accumulation is a problem. May not bear API service classification marks. PAO
(Group IV) Excellent VI, Excellent Pour Point, Excellent Thermal Stability May cause leakage in some instances. Additive stability in cold temperatures for extended periods of time may be a problem. *Information from How to Select a Motor Oil and Filter for Your Car or Truck, 2nd Edition, by James C. Fitch

When Synthetics Always Makes Sense

As mentioned, extreme conditions and worst-case scenarios demand the use of synthetics. Because they are so expensive, if you use them, insist on getting value and performance in return. Below are the passenger car applications that are ideally suited for synthetics motor oils:

• High-performance engines. There are many examples of high-end sports cars and even SUVs where the investment is high, as is the expectation of engine performance and reliability.
• High-performance driving. If you are involved in motor sports, then you will pay a premium for a competitive edge - power, endurance and engine reliability.
• Luxury car engines. Some luxury sedans are so expensive, it would clash with common sense to use anything other than a synthetic.
• Extreme cold starts. Certain synthetics can handle cold starts with no cranking or oil pressure problems at temperatures as low as -40°C (-40°F).
• Extended drains. If you've done the math (cost/benefit analysis) and believe your car, driving habits and climate conditions collectively are the perfect candidate for extended oil drains, synthetics give you the best shot and a safety margin.
• Towing and high loads. Slow speed, high load (e.g. towing), long hills, high-mileage engine, long oil service-interval, and high ambient temperatures are the worst-case scenarios. It's in these cases that oil films get extremely thin and high wear rates can ensue. This can be offset using premium synthetics with the best additive packages.
• Long engine life. The vast majority of the driving public have never owned a car with more than 200,000 miles on the engine. Many of us are genuinely not compelled to share the experience. Yet there is a large number of auto enthusiasts out there who try to get every last mile out of their car.

There are a few instances when the right decision on whether to use a synthetic motor oil is far more unclear - or simply just a close call. In such cases, your only tactic is to use good judgment and carefully consider all facts and circumstances. For instance, the jury is still out on the value, if any, that is gained in fuel economy by using synthetic motor oils. As mentioned previously, the opposite may be true.

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