INTRODUCTION:

Cosmetics compete as a chief character in human lifestyle. They may be drawn up in both artificial and natural ways. The artificially made cosmetics are normally composed of lots of detrimental synthetic excipients. Largely used are natural food, organic vegetables and herbal medicaments.¹ Lips are sensitive parts of the body that do not hold oil glands, so it is important to protect them by providing continuous moisture to the lips. Therefore, it is significant to provide heedfulness about the product as the lip balm is applied on the surface of lips and has occasionally been consumed by the body. They are normally applied to give hydration to the lips and appearance of lips.² The lip balms in general are composed of ingredients like beeswax, sunflower oil, shea butter, vitamin E and Jojoba. The history of lip balm can be traced back to the use of earwax, and Charles Browne Fleet who began commercially producing it in the 1880s. Amaranthus dubious leaves are rich in nutritional value and additionally, it is also a favorable crop. Global Industry Analysts, Inc [GIA] has set afloat the global market for lip care products, predicting it to reach US$2 billion by 2020. Beeswax is a common compound obtained by female bees that is often used in cosmetics mostly in lip balm. Beeswax acts as a natural emulsifier. Coconut oil used for the utterance of this herbal colorant lip balm is used for its mixing properties with the waxes that transmit the lip balm to coat in the film. The strawberry essence and orange major oil were used to flavor lip balm. These products are assessed for organoleptic properties like color, odor, spreadability, pH, melting point and skin irritation. The color of a product also gives a manifestation of product quality and spotlessness.³

Anatomy of Lips:

The lips function as organs for grasping, suction, and speech. They are composed of skin, the superficial orbicularis oris muscle, and surrounding tissues including areolar tissue and mucous membrane. The lips are protected by a specific stratified squamous epithelium known as the vermillion border, which is the distinct line that separates the red part of the lips from the surrounding skin. The areolar tissue or submucosal surface contains coronary vessels that encompass the mouth near the free margin of the lips.

Figure 1: Morphology of lips

The coronary vessels comprise the superior and inferior coronary arteries, which branch from the facial artery. The superior artery is larger than the inferior and connects with its counterpart on the opposite side, extending a small artery to the nasal septum. Constriction of this artery can sometimes control nasal bleeding. The lips are divided into five regions: the vermilion border/white roll, sub-vermilion, perioral, philtral column, and commissural. The sub-vermilion corresponds to the dry mucosal lip, while the perioral area represents the junction of the dry and moist mucosal lip. The edges of these subunits, including the cutaneous and mucosal segments of the lip, converge at the vermilion border, which has a distinct elevation called the white roll. The boundaries of the skin are covered with a reddish tint.⁴

Characteristics of lip balm:

Resilience to changes in temperature, Palatable taste, Harmlessness, Efficacy during the application, Adherence, and simple, deliberate eradication.⁵

Applications of lip balm:

Moisturizing lips, lip balms add a hint of color, add a glossy look, brighten lips, take away darkness, Lip creams are compounds applied to the lips that prevent drying and protect against harmful environmental factors.⁷

Advantages of lip balm:

Neither men nor women can wear them; they are products of all genders. Lip balm guards against dry, chapped, and sore lips.⁸ Sunblock lip balms have been shown to shield lips from UV ray damage. Revitalizes and relieves lip symptoms caused by allergies, colds, and the flu.⁶ Works flawlessly as a nighttime lip conditioner.⁹ Lip balm supports the natural health and attractiveness of the lips.⁷ Additionally, they provide organic nutrients that keep lips healthy.¹⁰

Disadvantages of lip balm:

Obtaining naturally derived colors and flavors is more difficult and there are problems with product stability. Other disadvantages of natural oils are greasiness, comedogenicity and poor lubrication.⁶Another problem associated with utilizing lip balm is addiction.¹¹ Homemade lip balms usually do not last as long on the lips as commercially prepared lip balms; therefore, you will need to reapply them often.¹ Some companies produce lip balm without considering the health benefits, focusing mainly on appearance. These products can gradually reduce the natural shine, color and softness of the lips.¹⁰

Lip disorders:

Inflammation: Cheilitis is an acute or chronic inflammation of the lips, which may be caused by infection, sun damage, medications, irritants, allergies, or underlying conditions. The inflammation primarily affects the vermilion and vermilion border, leading to swelling, redness, and pain. Other symptoms may include cracks, fissures, erosions, crusts, and scaling. Angular cheilitis (angular stomatitis) is the most common form, characterized by inflammation, crusting, painful fissures, and often softening at the corners of the mouth. Typical causes include Excessively worn teeth or dentures that do not adequately separate the jaws, creating skin folds at the corners of the mouth where saliva accumulates. Candida species (or sometimes Staphylococcus aureus). Iron deficiency, and vitamin B complex deficiencies (especially riboflavin and cobalamin).¹²

Figure 2: Lip Inflammation

Discoloration: Freckles and atypical brown spots around the lips, called melanotic spots, are common and can last for several years. These signs are nothing to worry about. Numerous small, scattered brown-black spots may indicate Peutz-Jeghers syndrome, a genetic disorder that causes polyps to form in the intestines and stomach. Kawasaki disease can cause dry and chapped lips and redness of the oral mucosa. It is an unknown disease that usually affects babies and children under the age of 6

Figure 3: Lip Discoloration

Sores: A lip ulcer with hard or sharp edges or a raised lip may be skin cancer. Other ulcers may appear as a sign of syphilis or oral herpes simplex virus infection, among others. Others, such as keratoacanthoma, have no known cause.⁶

Sun damage: After sun exposure, particularly the lower lip can become dry and hardened. To minimize damage, applying lip balm with sunscreen or wearing a wide-brimmed hat to shield your face from the sun's harmful rays is recommended.¹¹

Figure 4: Sun damage on lips

Swelling:

Lip swelling canbe caused by allergic reactions. Allergies to certain foods or drinks, medications, cosmetics, or airborne allergens can all cause reactions. Lips often return to normal once the underlying cause is found and removed. However, the cause of swelling is often unknown. Hereditary angioedema is a condition that can cause repeated episodes of swelling. Lip swelling can also arise from non-genetic factors such as erythema multiforme, sunburn, cold, dryness or trauma.

Common Fixings Utilized in Natural Lip Balm Formulation: The inventory of components employed as pivotal constituents in the formulation of lip balm is detailed in Table 1 as elucidated hereafter.

Table No. 1: List of Natural Ingredients¹⁴

Base^13-14	oils	Coloring agents	Flavoring agents
Cocca butter	Castor oil	Beetroot	Strawberry
Olive wax	Coconut oil	Carrot	Lemon
Raspberry butter	Grape seed oil	Pomegranate	Rosemary
Jojoba wax	Olive oil	Mango	Apricot
Olive butter	Sunflower oil	Orange	Pineapple
Sweet almond wax	Almond oil	Turmeric	Vanilla
Sweet almond butter	Sesame oil	Red cabbage	Chocolate
Avocado butter	Vitamin e oil	Amaranthus	Peach
Carnauba wax	Avocado oil	Strawberry	Rose oil
Yellow bee wax	Peanut oil	Watermelon	Watermelon
Candelilla wax	Lemon oil	Betel leaf	Sandalwood
White bee wax	Tea tree oil	Saffron	Mint
Shea wax	Arachis oil	Jabul	Saffron
Beeswax	Glycerine	Marigold	Orange
Shea butter	Castor oil	Cherry	Honey
Mango butter	Corn oil	Tomato	Cherry
Kokum butter	Jojoba oil	Alkanet root powder	Jasmine
Murumuru butter	Hemp seed oil	Moringa leaves	Raspberry
Illipe butter	Evening primrose oil	Dragon fruit	Coffee

Base: Waxes play a crucial role in the manufacturing of personal care items and ornamental cosmetics, serving as a vital group of ingredients. While candles are a primary application, waxes extend their significance across diverse industries, finding key roles in food, cosmetics and pharmaceuticals as thickeners or emulsifiers from a chemical standpoint, waxes constitute intricate blends of hydrocarbons and fatty acids combined with esters. In terms of physical attributes, waxes distinguish themselves from fats by being harder, less greasy, and more brittle. Notably, they exhibit remarkable resistance to moisture, oxidation, and bacterial degradation. There exist four distinct categories of waxes: (a) Animal waxes which include beeswax, lanolin and spermaceti; (b) plant waxes such as carnauba, candelilla and jojoba (c) mineral waxes encompass ozokerite, paraffin, microcrystalline and ceresin; (d) synthetic waxes, exemplified by polyethylene, carbowax, Acra wax and stearon. In the domain of cosmetic products bee waxes, carnauba and candelilla wax are notably waxes are prevalent. Physically waxes are identifiable by their melting points, typically ranging from 50-1000 C. Among them, beeswax is particularly notable for being the most widely utilized, valued for its effectiveness as both an emollient and thickening agent. In the cosmetic realm, carnauba and candelilla wax, being natural options, find common use due to their hardness and elevated melting points, providing stability, particularly in dry products like lip balm. Cocoa butter, a natural lipid extracted from cocoa beans, imparts a velvety softness to lip balm. Renewed for its ability to nurture and moisturize, it aids in healing chapped and dry lips, thanks to its antioxidant content. Another integral lip balm ingredient is white beeswax, boasting a melting point of 62-64c. Functioning as a valuable binder for oils and waxes with high melting points, it typically constitutes 3 to 10% of the overall formula. Noteworthy is its tendency to contract upon cooling, facilitating the creation of molded products. however, at higher concentrations, it can induce a matte appearance and lead to balm crumbliness during application. candelilla wax, with a melting temperature of 65-69C, finds utility in formulations at a 5-10% ratio. When combined with bee wax, it proves highly effective in crafting lip balm. Optimal results were achieved by slightly surpassing the beeswax quantity with Candelilla wax, resulting in a sleek and lustrous finish. Conversely, carnauba wax elevates the base’s melting point and fortifies the lip balm, necessitating its incorporation in minimal amounts.¹⁶

Figure 5: Bees wax Figure 6: cocoa butter

Oils: Oils and fats exhibit contrasting physical forms, with fats generally assuming solidity at room temperature. Oils and fats are glycerol compounds, composed of glycerol and fatty acids, recognized as triglycerides. Fatty acids can be either saturated or unsaturated, dictating the stability and characteristics of the oil. Oils containing a notable proportion of saturated fatty acids, like coconut, cottonseed, and palm oil, exhibit improved stability. Oils abundant in unsaturated fatty acids, encompassing canola, olive, corn, almond, sunflower, castor, and avocado oil, offer a smoother texture. Natural fats like shea, avocado, or cocoa butter function as exceptional emollients and thickeners. Saturated oils resist rancidity, while unsaturated oils present a less greasy feel and superior skin absorption. Sunflower or olive oil imparts a glossy appearance to lips, and castor oil is frequently integrated into lip balm formulations for its beneficial qualities A refined grade of castor oil, possessing no odor or taste, functions effectively as a plasticizing agent. Jojoba oil, recognized for its skin-softening attributes, proves advantageous in averting lip dehydration. An optimal oil mixture with waxes results in a thin film with commendable covering power on the applied lip skin. Antioxidants are added to castor oil to mitigate rancidity, even though it shows reduced vulnerability compared to other plant-based oils. Oil contributes to the promotion of skin softness in lip care.¹⁷

Figure 7: Almond oil Figure 8: Vitamin E

Colorants: Colorants or coloring agents are primarily utilized to bestow a distinct appearance to cosmetic products.¹⁹Color has been employed in cosmetics since ancient times. Fundamentally, the decision to acquire a cosmetic product is influenced by three senses: sight, touch, and smell. Consequently, color stands as a crucial element in cosmetic formulations.¹⁸ Lip color is achieved through two methods: (a) Staining the skin with a solution of dyestuff that can permeate the outer layer of lip skin, (b) Concealing the lips with a colored layer, which conceals any skin roughness and provides a smooth appearance. Soluble dyes fulfill the first requirement, while insoluble dyes and pigments meet the second, making the film more or less opaque. Contemporary lip balms incorporate both to attain the combined effect. The colors employed must originate from the list of approved pigments within the framework of the Drugs and Cosmetics Act Table number 2 provides an overview of naturally derived hues sourced from various plants and fruits. Colorants derived from natural sources must be non-toxic with no physiological activity. They should be definite chemical compounds to ensure reliable coloring power, practicable assay, and ease of use. Their tinting power should be sufficiently high so that only minimal quantities are required.¹⁸ They must be resilient against oxidizing and reducing substances, pH changes and should not hinder tests and assays. Water-soluble colorants are as desirable as oil-soluble and spirit-soluble colors. Compatibility with other ingredients and medicaments is a crucial characteristic of colorants. They must lack unpleasant flavor and scent and be easily accessible and cost-effective. Instances of natural pigments are sourced from beetroot, saffron, turmeric, and so forth. The principal coloring agent in saffron is crocin, a yellow powder, a glycoside in nature, and easily soluble in water.¹⁷

Flavoring Agents:

Flavoring agents or aroma compounds are typically employed to obfuscate the four fundamental taste perceptions. Flavor encompasses a composite experience involving taste, tactile sensation, olfaction, visual cues, and auditory input, all orchestrated by a blend of physiochemical and physiological processes that shape substance perception. With the burgeoning technological advancements in the flavor industry, numerous synthetic or mimic flavors have been innovated. Crafting an acceptable flavor is predominantly an artistic endeavour, transcending mere scientific methodology. Selection of flavorants is contingent upon aligning with the taste profile of the pharmaceutical or other constituents requiring incorporation. Table 3 delineates the masking flavors concerning distinct tastes. Flavors utilized in lip balm formulations require the exclusion of any potentially irritating or toxic components. They should exhibit pleasing taste qualities and proficiently conceal the fatty Odor inherent in the base composition. Flavoring agents are indispensable in suppressing the olfactory nuances of the fatty or waxy foundation while concurrently infusing an appealing taste.

Table No. 3 List of Flavours¹⁴

Taste	Masking agent
Sweet	Vanilla, fruit berry, vinegar
Bitter	Chocolate mint, walnut, liquorice, wild cherry, honey, dates, molasses
Acid	Lemon, amla, orange
Salt	Maple, butterscotch

Method of Lip Balm Preparation:

This section describes the specifics of the common lip balm preparation procedure. First, precisely weigh the waxes and then melt them in a hot water bath the melting point declining in order, stirring and heating the mixture continuously until it melts completely. The coloring ingredient is then added to the combination of melted waxes after being dissolved in either water or oil, depending on its solubility. Lastly, add flavoring agents like vanilla and honey, which also serve as preservatives, and stir the mixture constantly to achieve homogeneity. Till a smooth emulsion form, the mixture needs to be rapidly agitated. The liquid could then be placed into molds that had been cleaned and lubricated, and the Molds could be left to cool so that the waxes would shrink and make the balm easier to remove. Lately, the manufacturing of botanical butter stick lip balm cosmetics has also been patented.¹⁴

Assessment of lip balm:

Evaluation tests for lip balm involve measurements to ascertain the product’s performance, quality, and efficacy. Criteria like moisturizing power, longevity, smell, texture, and overall consumer pleasure may be part of these tests.²

Melting Point:

Melting point is one of the essential parameters to identify the drug and its crystalline state. Furthermore, deviation in melting point gives the clue of drug substance purity. The melting point can be estimated by the open capillary tube method. The sample is placed in a glass tube attached to the thermometer. The glass tube containing the formulation is dipped in liquid paraffin which is in the melting point apparatus. The temperature rise was observed. The point at which the sample started melting is recorded. The experiment is performed three times. The average of the melting point is considered the melting point of the formulation.³

Figure 12: Melting point apparatus

Organoleptic properties:

The organoleptic characteristics of lip balm encompass aspects like color, fragrance, and visual impression.

Test for spreadability:

To visually assess the consistency in forming a protective layer with the lip balm and to determine the broken/ tilt or stick split during application. The spreadability test is conducted at room temperature by repeatedly administering the product onto a glass slide. The spreadability can be estimated by using the given formula:³

Spreadability = M × L/T

Where,

M = mass in grams

L = Distance travelled by lip gloss

T = Time in seconds¹⁹

Figure 13: Spreadability test on lip balm

G: Good, Congruent, Impeccable application, no disintegration, decomposition, no lip balm deformation.

I: Intermediate, Consistent, minimal lip balm distortion.

B: Incompatible, improperly applied, causes lip balm to deform.

PH measurements:

The lip balm pH is measured to assess for any potential adverse effect. ApH below or above seven causes Irritation, so it is mandatory to maintain the pH of lip balm neutral.

Procedure: 1g of formulation dissolved in 100ml of water to measure the pH value. The pH value can be measured by using a pH tester.³

Figure 14: PH test of lip balm

Skin Irritation Test:

To conduct a skin irritation test for lip balm, apply a small amount of the sample on a patch of skin (like the inner arm) and observe for 10 minutes. Check for redness, erythema, swelling and any adverse drug reactions.

Breaking point:

The turning point method is used to estimate the potency of the lip balm. The lip balm rested just one inch away from the edge of the support, positioned horizontally within a holder. The mass is systematically incremented by 10 g at a fixed 30-second time interval. The weight at which it broke was considered the breaking point.

Perfume stability:

After 30 days, the formulation underwent testing to document its fragrance.

Stability studies:

The stability studies were conducted over a period of 30 days at room temperature (25°C), refrigerator (5°C), and oven temperature (40°C) for organoleptic characteristics, melting point, pH, and spreadability of prepared lip balm.³

Effectiveness test on paper:

Eventually, after taking out the lip emollient from the chilling unit, it is tested by applying lip gloss on a sheet of paper. This procedure is crucial for determining the resultant color obtained from various sources. It also gauges the effectiveness of the color of the product.²⁰

Surface Anomalies:

This was examined for surface flaws in the lip balm formulation, such as crystal formation and fungal or Mold contamination.

Aging Stability:

A one-hour storage at 40°C was usedto assess the product's stability. Then, several characteristics were noted, including bleeding, surface crystallization, and application ease.

Test for Solubility:

The solubility of formulated herbal lip balm was determined by dissolving in various organic solvents such as ethanol, chloroform, etc.²

Greasiness:

Theamount of oil in the lip balm formulation was determined by looking at the greasiness test. In this investigation, four grams of lip was placed onto the filter paper and the sample was maintained at ambient temperature for twenty-four hours. The oily ring diameter that is produced was measured.²¹

REFERENCES:

1. Devkate Ankita D et al. Review on Natural Lip Balm. Journal of Emerging Technologies and Innovative Research. 2022; 9(1): c826-c831.

2. Yadav A et al. Formulation and Evaluation of Herbal Lip balm from Amaranth Leaf Colour Pigment. International Journal for Research in Applied Science and Engineering Technology. 2020; 8(4): 653- 662.

3. Riya Patil et al. Formulation and Evaluation of Lip Balm Prepared Using Various Herbal Entities. International Journal of Innovative Research in Technology. 2023; 9(12): 775-779.

4. Vitnorshubham et al. A review on Herbal Lip Balm. IJARIIE. 2022; 8(5): 1297-1305.

5. Ms. Siddhi et al. An overview and introduction to herbal lip Balm. International Research Journal of Modernization in Engineering Technology and Science. 2023; 5(12): 2986-2989.

6. Ms. Pooja. D et al. Formulation and Evaluation of Natural Lip balm. International Journal of Research Publication and Reviews. April 2023; 4(4): 907-911.

7. Pratiksha Appa Saheb Bhoite et al. Review on Herbal Lip Balm. International Journal of Pharmaceutical Research and Applications. Nov-Dec 2022; 7(6): 1827-1832.

8. Chaitanya Dnyaneshwar Gholap et al. Preparation and Evaluation of Herbal Lip Balm. International Journal of Innovative Research in Technology. 2023; 11(3): 1-13.

9. UrwashiLanjewar et al. Formulation and evaluation of herbal lip balm infused with papaya and turmeric. Journal of Critical Reviews. 2020; 7(8): 3905-3914.

10. Tanvi Bali et al. Organic lip balms: A mini review. World Journal of Pharmacy and Pharmaceutical Sciences. 2021; 10(7): 850-859.

11. Sakshi Paithankar et al. Formulation of Natural lip balm. International Research Journal of Engineering and Technology. Jan 2023; 10(1): 1009-1014.

12. https://www.merckmanuals.com/home/mouth-and-dental-disorders/lip-and-tongue-disorders(Assessed on 30 November 2014)

13. A.R. Fernandes et al. Stability evaluation of organic Lip Balm, Brazilian Journal of Pharmaceutical Sciences. 2013; 14(2): 293-299.

14. Mayuri Kadu et al. Review on Natural Lip Balm. International Journal of Research in Cosmetic Science.2015; 5(1): 1-7

15. R.G. Harry, J.B. Wikinson, Harry’s Cosmetology, sixth ed. Leonard Hill Books and Intertext Publisher, London,1973; 8(5): 1297-1305

16. P.P. Sharma, Cosmetics- Formulation, manufacturing and quality control, fourth ed. Vandana Publications Pvt.Ltd, India, 2008.

17. K.V. Allam et al. Colorants the cosmetics for the pharmaceutical dosage forms, Int. Jou. Of Pharmacy and Pharm. Sci., 3 (2011) 13-21.

18. S.A. Sahar et al. The effects of using color foods of children on immunity properties and liver, kidney on rats, Food and Nutrition Sciences. 3 (2012) 897-904.

19. Vineetha K et al. Formulation and evaluation of herbal lip balm using natural pigments. European Journal of Biomedical and Pharmaceutical Sciences. 2023; 10(2): 248-251.

20. Telange -Patil P et al. Formulation and evaluation of herbal lip balm. International Journal of Creative Research Thoughts. 2002; 10(10): A60 – A65.

21. Siti Nuurul Huda Mohammad Azmin et al. Physicochemical and sensory evaluations of moisturizing lip balm using natural pigment from Beta vulgaris. Cogent Engineering. 2020; 7(1788297): 1-14.

Received on 27.04.2024 Revised on 17.08.2024

Accepted on 01.10.2024 Published on 20.12.2024

Available online from November 25, 2024

Res. J. Pharmacognosy and Phytochem. 2024; 16(4):242-248.

DOI: 10.52711/0975-4385.2024.00045

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

Color	Chromophore	Sources	Nutrients
Red	Lycopene anthocyanins	Strawberry, sweet cherry, raspberry, grape, plums, pomegranate, onion, cabbage	pelargonidin, cyanidin, peonidin, delphinidin, petunidin, and malvidin
Yellow-orange	Carotenoids	Pumpkins, carrots, corn, tomatoes, oranges, papaya, Sweet bell pepper, sweet potato	lutein, zeaxanthin, flavonoid, vitamin C, astaxanthin, carotene
Purpleblue	anthocyanins	Bilberry, brinjal, blueberries, figs, grapes, purple potatoes, purple kale	Phosphorous, quecetin, vit c, flavonoid, resveratrol, ellagic acid, zeaxanthin
green	Chlorophyll	Spinach, cucumber, melon, kiwi, parsley, lettuce, peas, mint,	carotene, vit c, lutein, calcium, zeaxanthin, folate,
Whitetan	Anthoxanthins	banana, cauliflower, garlic, mushrooms ginger,	Selenium, anillin, potassium


Figure 9: lip balm	Figure 10: strawberry	Figure 11: Vanilla