Development Team

Principal Investigator Prof. Farhan J Ahmad JamiaHamdard, New Delhi Dr. Vijaya Khader Former Dean, Acharya N G Ranga AgriculturalDr. Javed AliUniversity Paper Coordinator Jamia Hamdard, New Delhi

Content Writer Dr. Sanjula Baboota Jamia Hamdard, New Delhi

Prof. (Mrs.) Kamla Pathak Content Reviewer Professor, Pharmaceutics

Pharmaceutical sciences Lip Care Products 0

Lip Care Products 2016

CONTENTS

. Introduction . Anatomy and physiology of human lips . Types of lip care products  Lip liners  Lip glosses  Lip salve/ balm  . Required qualities and characteristics of lip care products . Ingredients for lip care products . Formulation . Manufacturing procedure . Packaging of lip care products . Evaluation of . Marketed lip care products

LIP CARE PRODUCTS

Pharmaceutical Cosmetics sciences Lip Care Products 0

Lip Care Products 2016

1. INTRODUCTION

Lip care products are primarily used by women to enhance their attractiveness and femininity; however, there are products available for men as well. Products for men usually include uncolored sticks offering hydration and sun protection.

In its most basic form lipstick is the mix of oils, waxes and pigments which form a mass that can easily be applied to our lips. Developing a feasible formula is not an effortless job, and for a good lipsticks a lot of time and sometimes hundreds different types of recipe is needed to make it perfect. Some of the few important properties of lipsticks are its color, opacity, fragrance, and dryness.

2. ANATOMY AND PHYSIOLOGY OF HUMAN LIPS

Human lips have a complex anatomy consisting of mucosa and skin. The outer surface of the lips is covered by epidermis and hair, sweat glands, and sebaceous glands. The skin of the face meets the mucous membrane of the mouth in a transition zone called the vermilion border. This transition zone is characterized by lightly keratinized epithelium; it does not contain hair or sweat glands. The inner surface of the lips is continuous with the oral mucosa, which is covered with non-keratinized epithelium and contains numerous tiny salivary glands. In the red area of the lip (i.e., vermilion border), cornification and pigmentation of the epithelium diminish. The red color of the border area is thought to be the result of the decreased density of keratin along with the translucency of the tissue, which allows the observer to see easily the small capillary vessels. This is the zone where makeup products are applied to. Figure 1 depicts the different parts of the lips.

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Figure 1: Structure of the human lip.

Human lips have a specific shape due to the muscles and soft connective tissue of which they are made. The muscle, the so-called orbicularis oris muscle, makes a hooked curve toward the exterior at the edge of the vermilion area, which gives the lips their shape. The physical appearance of the Cupid’s bow is also caused by the configuration of the underlying muscle.

The production of natural emollients is very low in the lips. In addition, it also appears to contain less water than other areas of the face and lose water faster than the cheeks. As a result, human lips can become dry and chapped easily.

An interesting characteristic of the vermilion border is that it has very rapid cell turnover. This is why the lips recover very quickly if they are injured or burned. Another specific property of the lips is that they have a lot of sensory receptors and have great tactile sensitivity. According to the literature, the sensitivity of the lips is similar to that of the tongue and the fingertips. In addition to being sensitive to touch, lips are very sensitive to chemical, physical, and microbial damages as well. The fact that lips are not rich in keratinized cells and melanin significantly contributes to their sensitivity. Their prolonged exposure to sunlight may lead to visible damage, and they can be more easily infected with yeast and bacteria than other parts of the skin.

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Lip Care Products 2016

The quality and structure of lips change over time. As a person grows older, thinning skin, loss of muscle support, changes in bone structure, bone resorption, and reductions in soft tissue volume lead to a number of changes in the perioral region (i.e., the area around the lips). The lips become flat and thin and less shapely. In addition, fine lines and deeper wrinkles develop on the upper and lower lips that may cause lip makeup products to flow into these lines from the red area of the lips; this phenomenon is usually referred to as “bleeding.” The tactile sensitivity of the lips decreases with age as well.

3. TYPES OF LIP CARE PRODUCTS

There are several different types of products available in the market that can be applied to the lips for various reasons.

3.1. Lipsticks are designed to enhance the appearance of the lips by imparting color and gloss. They consist of waxes, butters, fats, oils, and hydrocarbons, which are usually referred to as the base, as well as pigments for the color. Additionally, lipsticks can contain flavors and fragrances as well as specific ingredients for ultraviolet (UV) protection and a plumping effect.

3.2. Lip salve/ balm are used to protect lips from drying during winters. These do not contain colours. Requirements of lip salves are that these should form an adherent, moisture resistant film on lips. These can be prepared from fatty materials like mineral oils, jelly and waxes. To make film more adherent a small proportion of hydrophilic material should be included in the formulation.

3.3. Lip glosses are designed to give the lips a glossy luster and, sometimes, subtle color. They usually have a lower viscosity than traditional lipsticks and are more transparent. Lip glosses consist of a higher ratio of oils and lower ratio of waxes; therefore, they are applied smoothly, have a greater shine, but do not wear as long as a lipstick does. They can be clear or translucent

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or exhibit various shades of opacity with various finishes, such as metallic, glittered, glassy, and frosted.

3.4. Lip liners are designed to redefine the outline of the lips. They consist of blends of waxes, butters, fats, and oils, similar to lipsticks; however, the finished formulation is harder and the level of pigments is slightly lower. Lip liners are most often slim pencils, or fluids encased in special “pens,” to which is attached a fine brush through which the product is dispensed.

4. REQUIRED QUALITIES AND CHARACTERISTICS OF LIP CARE PRODUCTS

 Attractive shades  Homogeneous color when applied  Good coverage  Long-lasting effect  Pleasant taste and smell  Easy to apply  UV protection (common requirement)  No staining or bleeding into the fine lines surrounding the lips  Provide a wet and shiny look  Lip liners: have high pigment content to accent the lines of the lips, firm enough not to run into the lines around the lips  Lip balms: moisturizes the lips and prevents chapping.

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Lip Care Products 2016

5. INGREDIENTS FOR LIP CARE PRODUCTS

5.1. Coloring Materials

Coloring materials are the most important components from a commercial and appearance point of view since colors set lipsticks apart in most consumers’ minds. The use of colorants is strictly controlled by the FDA, and color additives are specifically approved for the mouth area.

Typically, the following types of color additives are used in colored lip care formulations such as organic colors, inorganic pigments, lakes, and specific effect pigments. Dyes are readily soluble, whereas pigments are insoluble in the medium/vehicle in which they are used. Effect pigments may include particles that provide pearlescent effect, sparkle, luster, glitter, matte, metallic, and other types of effects to lipstick formulations. Effect pigments used in lip makeup products are generally available in various colors and particle sizes. By varying the particle size of these ingredients, different effects can be achieved. Smaller particles (in the range of 20 μm) create silky and satin effects and opacify the mass. Larger-sized particles (in the range of 120 μm) reachhigh luster effects, sparkling, or glittering, combined with high brilliance and transparency. Special pigments generally do not add color to formulations in large quantity; therefore, they are usually combined with regular color additives. However, in low-color products, such as lip glosses or lip balms, they can be used alone. Examples of different pigments and colors are as follows:

 Inorganic pigments:-Iron oxides (red, yellow, brown, and black), titanium dioxide, and zinc oxide;  Organic colors:-Reds (such as Red 6, 7, and 21), yellows (such as Yellow 6), oranges (such as Orange 5 in a concentration ≤5%)  Lakes:- Red 7 Lake and Yellow 5 Lake.  The most frequently used special effect pigments include micas coated with iron oxides and titanium dioxide (which can provide a sparkly or glittery effect, a soft luster, or a

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pearlescent effect depending on the coating), and bismuth oxychloride (which provides a pearlescent effect).

Table 1: Percentage of colour used. Ingredients % Staining dye (bromoacids) 0-0.2 Oil soluble pigment 2 Insoluble pigment 8-10 Titanium dioxide 0-4 Pearlaceous pigment 0-20

5.2. Waxes

Waxes function as structuring agents, providing lipsticks with rigidity and hardness. In addition, they stabilize the sticks and allow them to be molded into shape. By modulating waxes with different competence, like as high shine, flexibility, and brittleness, optimal cosmetic performance can be achieved. Due to unique composition and chain lengths of waxes the melting points vary widely. They are usually mixed with oils to achieve the desired softness; waxes alone would be too rigid.

Examples of waxes:- Beeswax, candelilla wax, carnauba wax, paraffin wax, ozokerite wax, microcrystalline wax, polyethylene, and lanolin alcohol.

5.3. Oils, fats, and butters

Oils, fats, and butters provide a slippery and soft texture to the formulations. They also have a moisturizing effect and act as emollients, i.e., prevent drying and chapping of lips. Oils are also used to disperse pigments and pearls. A fact that should be taken into consideration when adding oils to a formulation is that a high concentration (typically above 50%) may result in a greasy and sticky feeling. Butters and fatty acid esters can improve the adhesiveness for the

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formulations to the lips. Low molecular weight silicones may also be used, and since they are volatile, they can provide excellent carrier properties for transfer-resistant lipsticks. Example of commonly used oils, fats, butters etc are:

Plant oils:-Castor oil, grape-seed oil, almond oil, meadowfoam oil, olive oil, coconut oil, palm oil, and triglyceride.

Butters:-Avocado butter, shea butter, and cocoa butter.

Fatty acid esters:-Isopropyl myristate, isopropyl palmitate, isostearylisostearate, and butyl stearate.

Hydrocarbons:-Polyisobutene, mineral oil, petrolatum, isododecane, and isoeicosane.

Silicones:-Dimethiconeand cyclomethicone.

5.4. Antioxidants

They are added to prevent rancidity and the oxidation of sensitive ingredients. For example, vitamin E, butylated hydroxyanisole (BHA), and butylated hydroxytoluene (BHT) are commonly used.

5.5. Preservatives

They provide protection against microbiological contamination. For example, parabens and phenoxyethanol are frequently used.

5.6. Fragrances

They can be used in lip makeup products to mask fatty or wax odor. They should be neither irritant nor toxic by ingestion, and their taste must be agreeable as well. In addition, they should

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be stable at higher temperatures since the formulation of lip makeup products might take place at a higher temperature.

5.7. Flavoring agents

These are also to be added to formulations to provide a pleasant taste. Lip makeup products may get in contact with the taste buds as opposed to the majority of cosmetic products, which are not ingested. Therefore, product taste should also be taken into consideration. Any FDA-approved food flavoring agent can be used for flavoring. Taste can also be adjusted by using sweeteners, such as sodium saccharin. Lip plumping lipsticks containing cinnamon or menthol are also popular today. These ingredients add a specific flavor to the formulations.

5.8. Texturizing ingredients

Texturing ingredients such as talc, silica, and mica, may also be used to improve the texture, application, and stability of products. Additional examples include titanium dioxide, which provides a soft focus effect (spherical ingredients are able to scatter light in different directions, making the skin appear soft and blurred, which is referred to as a soft focus effect), and bismuth oxychloride, which gives a satin, shimmering effect to the products.

5.9. Fixatives

Certain products, mainly long-lasting formulas, contain fixatives that prevent colors from bleeding on the lips; they help seal the lipsticks on the lips. For example, silicone resins are used as fixatives in lipsticks.

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6. FORMULATION:

A general formula for lipstick base is represented in table 2.

Table 2: A general formula for lipstick base.

S. No. Ingredients Percent use 1. Beeswax 18.0 2. Lanolin 5.0 3. Cetyl alcohol 2.0 4. Castor oil 30.0 5 Mineral oil 3.0 6. Isopropyl myristate 2.0 7. Ozokerite wax 10.0 8. Carnauba wax 3.0 9. Propylene glycol 10.0 10. Propylene glycol mono-myrisatate 5.0 11. Lake colors (mixture of titanium dioxide + Lake color) 10.0 12. Bromoacids 2.0 13. Perfume, preservatives & anti-oxidant q.s

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A general formula for lipstick base is represented in table 3.

Table 3: A typical formula for lipstick.

Ingredient Purpose Percent use Castor oil Diluent oil 6.20 Octyl palmitate Solidifier 10.00 Carnauba wax Solidifier 4.00 Ceresin, (m.p. 80 "(C) Solidifier 10.00 Microcrystalline wax Solidifier 6.00 Cyclomethicone (D5 ) Diluent oil 42.00 Dimefhiconol beeswax Pigment dispersion 4.00 Methylparaben Preservative 0.20 Propylparaben Preservative 0.10 D&C Red No. 7 Calcium lake Colorant 3.50 D&C Red No. 6 Barium lake Colorant 0.50 Mica and methicone Colorant 7.50 Bismuth oxychloride Colorant 6.00

The preparation of lipstick involves the following distinct steps:

1. Predissolve the dimethiconol beeswax in the cyclomethicone in a closed container by stirring at 50-55°C. 2. In a sealed kettle, combine the dimethiconol beeswax solution and the remaining waxes and oils. Heat to 85°C with stirring. 3. Add the pigments. Mill with a high-speed agitator until a fine grind is obtained. 4. When pigment is dispersed, cool to 70°C and fill inmolds.

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A general formula for lip salve base is represented in table 4.

Table 4: General formula for lip salve.

S. No. Ingredients Percent use 1. Paraffin wax 25.0 2. White petroleum jelly 40.0 3. Paraffin oil 20 4. Beeswax 15.0 5. Perfume & preservatives q.s

7. MANUFACTURING PROCEDURE

The most common lipstick manufacturing procedure is done in four stages.

7.1. Pigment milling

In this step the desired pigment or the combination of pigment are chosen and then carefully mixedtogether. Then, pigment is mixed with oils and put through three-roll mill which powders the particle and reduce them up to the size of 20 microns.

7.2. Combination of pigment phase into base wax

This is done with simple mixing of those liquids in a steam-jacketed kettle that is equipped with one propeller agitator. After successful mixing, resulting liquid is again passed through three roll mill and usually crushed down to particle sizes of 20 microns.

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7.3. Molding

This is done at specific temperature to eliminate certain unwanted products of fast cooling (sometimes called “cold marks”). Lipsticks liquid that is heated to around 80 0C is poured into vertical split molds that are kept at temperature of around 35 0C. To prevent formation of air bubbles in the molds, manufacturers often use slightly tilted molds or use vacuuming to forcefully extract any air.

7.4. Flaming

In this step resulting lipstick is cooled down, taken out from the molds and prepared for flaming (passing of the lipsticks near one or more open flame torches that will melt small layer of gloss around lipsticks). This procedure providesinsurance for better visual appearance of the lipstick, and protection from environmental conditions (lipsticks can become rancid after prolonged exposure to moisture, air and heat).

7.5. Packaging and labeling is compeleted with the requirements of the manufacturers of brand owner.

8. PACKAGING OF LIP CARE PRODUCTS

The most commonly used packaging materials for lip makeup products include the following:

 Lipstick Cases: Classical packaging for lipsticks and lip balms includes the cases, also called tubes. The tubes have a swiveling, twisting, or pushing base that lifts the lipstick up from the hollow cylinder. Lipsticks are placed in the cases after molding and cooling, while lip balms are directly molded into the tubes.  Tubes: Lip glosses are usually dispensed from clear glass or plastic tubes to which is fitted a cap that incorporates with an applicator attached to the bottom. Products with a lower viscosity, e.g., lip glosses, can be packaged into soft tubes that

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are fitted with a roller ball in the housing. Medium-viscosity formulas that are still not sticks, e.g., softer lip balms at room temperature, can be dispensed in soft tubes that are fitted with a slant-tip applicator.  Jars and Pots: Alternatively, lip glosses and lip balms can be packed into small jars, pots, or thin metal tins, which are then applied with fingers.  Pencil Cases: Lip liners and some lip glosses are packaged into wooden or plastic pencil cases. The plastic cases are similar to the lipstick cases; they can twist and push the lead up during application.

9. EVALUATION OF LIPSTICK

In order to maintain uniform standards for lipstick the following evaluation tests are conduct.

9.1. Melting point

For safe storagedeterminations of melting point an important parameter. Capillary tube method is used for determination of melting point of formulated lipstick.The capillary isloaded and place in the capillary apparatus and time taken for the product to melt completely at 540 C is recorded. This procedure is repeated three times and the average melting point is recorded.

9.2. Softening point

The softening point is an important parameter which provides an indication whether lipsticks will be able to withstand variation in climate or not. The softening point of lipsticks should be sufficiently high so that the lipstick can withstand such high temperature as 480C. The Indian standard for lipsticks prescribes that it should have softening point not less than 550C. In case, the product of desired softening point has not been made and the softening point is to be increased, wax (es) of higher melting point may be added to increase the softening point.

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9.3. Breaking point

Breaking point helps in estimating the strength of lipstick. In this lipstick is held horizontally in a socket an inch away from the edge of support. The weight is gradually increased with aspecific value i.e., 10 gm at specific interval of time (30 second) and the weight at which breaks is recorded and is considered as the breaking point. Test should be made at a given temperature i.e. 250C or 300C.

9.4. Color matching

Color matching is the process when dispersed pigments and the finished product are compared to a previously approved standard color. It is essential to produce the same shade of a lipstick every time a company manufactures it. The test can be done visually or using spectrophotometers that provide quantitative information on the shade. If done visually, the testing environment and lighting should be standardized since many artificial light sources might distort the color seen.

9.5. Color brightness and streakiness

Color brightness and streakiness of lip makeup products can be evaluated visually, and using a spectrophotometer or colorimeter. Spectrophotometers and colorimeters provide quantitative information on the color; therefore, they can identify the match with the previous batches. Color on an application surface can be evaluated by image analysis. With this technique, it is possible to study the skin areas of various sizes, take measurements without any contact with the skin, and analyze the image pixel by pixel, providing quantitative information according to localization.

9.6. Rigidity of pencils and lip gloss pencils

The rigidity of a lip liner or a lip gloss pencil core must allow the tip to be sharpened to a certain point to provide a defined line upon application without scratching the lip of the user. An ideal product should not be so soft to cause smudging around the lips or have the tendency to become

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crumbly or brittle after prolonged or low-temperature storage. It measures the force (load) needed to break the tip of the pencil. This technique enables to quantitatively measure the hardness/rigidity of the pencil’s tip.

9.7. Moisturizing effect

Lip balms and other lip makeup products claiming to moisturize the lips should truly provide moisturization on application. The moisturizing effectiveness of lip makeup products is usually evaluated similar to that of skin moisturizing products. Methods include noninvasive techniques, such as conductance and capacitance. Hydration state is generally measured at the beginning of the experiment to obtain a baseline value, and then it is continuously measured during the study. At the end of the study, the baseline values are compared to the in-study values and are analyzed statistically.

9.8. Aging stability

The products are stored in 40ºC for onehour. Different parameters like as bleeding, crystallization of on surface and ease of application aredetermined.

9.9. Solubility test

The formulated lipstick was dissolved in various solvents to observe the solubility.

9.10. pH determination

The pH of formulated lipsticks is determined using pH meter. The pH of formulation should be between 5.5 to 6.5.

9.12. Perfume stability

The formulated lipsticks are tested after 30 days, to record fragrance.

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Table 5: Top lip care brand Brand Manufacturer Revlon, Inc., New York City Lakme Hindustan Unilever Ltd, India Colorbar Samir Modi, India M.A.C. MAC cosmetics, Toronto L'Oréal L'Oréal S.A., Paris NYX NYX cosmetics, Los Angeles Lip Balms Beiersdorf Global AG., Germany Lotus Herbals Lotus Herbals Ltd., India Unilever, United States

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