FORMULATION AND EVALUATION OF LIP LIGHTNING

AND MOISTURIZING BALM

Dissertation submitted in the partial fulfillment for the Degree of

Bachelor of Pharmacy

In the faculty of Pharmaceutical sciences

Savitribai Phule Pune University

Submitted By
Mr. Tanmay Walunj

Guided By
Ms. Rasika Deshpande
(Assistant Professor, Department of Pharmaceutics)

Dr. D. Y. Patil College of Pharmacy

Dr. D. Y. Patil Educational Complex, Sector-29
Pradhikaran, Akurdi, Pune-411044 2020-2021

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

 CERTIFICATE

This is to certify that the work presented in this dissertation entitled

“FORMULATION AND EVALUATION OF LIP LIGHTNING
AND MOISTURIZING BALM’’

In the partial fulfillment of Degree of Bachelor of Pharmacy in the faculty of

Pharmaceutical sciences, Savitribai Phule Pune University has been carried
out by Mr. Tanmay Walunj in the laboratories of Dr. D. Y. Patil College
of Pharmacy, Akurdi, Pune-411044, under the guidance of Ms. Rasika
Deshpande, Assistant Professor. This report is now ready for examination.
Materials and services obtained from various sources have been
acknowledged in this dissertation.

Date: 10 June,2022 Dr. N. S. Vyawahare

Place: Pune Principal
Dr. D. Y. Patil College of Pharmacy,
Akurdi, Pune- 411044

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

 CERTIFICATE

This is to certify that the work presented in this dissertation entitled

“FORMULATION AND EVALUATION OF LIP LIGHTNING
AND MOISTURIZING BALM’’

In the partial fulfillment of Degree of Bachelor of Pharmacy in the faculty

of Pharmaceutical sciences, Savitribai Phule Pune University has been
carried out by Mr. Tanmay Walunj in the laboratories of Dr. D. Y. Patil
College of Pharmacy, Akurdi, Pune-411044, under my guidance and to my
satisfaction. This report is now ready for examination. Materials and
services obtained from various sources have been acknowledged in this
dissertation.

Date: 10 June,2022 Ms.Rasika Deshpande

Place: Pune Research Guide
Dr. D. Y. Patil College of Pharmacy,
Akurdi, Pune-411044

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

 DECLARATION

I declare that the Dissertation entitled ““FORMULATION AND

EVALUATION OF LIP LIGHTNING AND MOISTURIZING
BALM’’ is my own work carried out under the guidance of Rasika Deshpande
at Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune. I further declare that to
best of my knowledge the dissertation does not contain any part of any work which
has been submitted for the award of any degree either in this University or in any
other University/ Deemed University without proper citation.

Date: 10 June,2022 Mr.Tanmay Walunj

Place: Pune

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

 ACKNOWLEDGEMENT

It is both an elevating and humbling experience to have the opportunity to acknowledge

numerous people involved in this dissertation work. I would like to have some space here to
thank some of them who gave concrete space to this work.
It is my great pleasure to acknowledge my dissertation guide Ms. Rasika Deshpande ,
Department of Pharmaceutics, Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune. who has
helped me lot during my dissertation work. I would like to sincerely thank, for her able
guidance, constant supervision, motivation, support, useful suggestion as well as for providing
the excellent facilities and the necessary information for the successful completion of the
project.
I would also like to extend my gratitude to Dr. N.S. Vyawahare, Principal, Dr. D. Y. Patil
College of Pharmacy, Akurdi, Pune, and all other faculty members of our college for their
kind co-operation, encouragement and guidance.
I am very thankful to Dr. D. Y. Patil College of Pharmacy for their encouragement, motivation
and valuable suggestions during the course of work.

It is indeed a difficult task to acknowledge the service of all those gentle people who have
extended their valuable suggestion and support. Directly or indirectly whose names have been
unable to mention as they are like the countless stars in numerous galaxies.
Above all again last but not least; I am indebted to the Almighty. It is the faith and trust on
God to give me strength to overcome all difficulties. It is his blessings that where I am today.
MY SINCERE THANKS TO ALL

Date: Mr. Tanmay Walunj

Place: Pune

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

 INDEX
Chapter Chapter Name Page No.
No.

1. Introduction 08-11

2. Plan of Work 12-13

3. Literature Work 14-15

4. Formulation 16-20

5. Physiochemical Evaluation 21-25

6. Summary & Conclusion 26-28

7. References 28-33

8. Errata 34-38

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

LIST OF FIGURES
Figure No. Figure Name Page Number
1 Ancient Chinese Lip Balm 9

2 Cleopatra 9

3 The American Frugal 10

Housewife

4 First Lip Balm 10

5 First Medicated Lip Balm 10

6 First FDA approved Lip 11

Therapy.

7 Vintage Newspaper Ads of 17

Lip Balms

8 Materials Used 19

9 During Formulation Process 20

10 Final Formulation of Lip 22

Balm

11 pH of the Formulation 22

12 Melting Point determination 22

13 Spreadblity Test 23

14 Skin Irritation Test 23

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 1 Introduction

INTRODUCTION

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 1 Introduction

Lip Balm:
Lip balm, also known as lip salve, is a waxy material that is applied topically to the lips to
moisturise and alleviate chapped or dry lips, angular cheilitis, stomatitis, and cold sores.
Beeswax or carnauba wax, camphor, cetyl alcohol, lanolin, paraffin, and petrolatum are all
common constituents in lip balm. Dyes, flavour, fragrance, phenol, salicylic acid, and
sunscreen are all included in some variations. Lip balm's main function is to create an occlusive
layer on the lip surface that seals moisture in the lips and protects them from the elements. Dry
air, chilly temperatures, and wind all take moisture away from the body, causing skin to dry
out. Lips are especially susceptible because to their thin skin, and they are frequently the first
to show indications of dryness. Waxes and petroleum jelly are occlusive materials that prevent
moisture loss and keep lips comfortable, while flavourings, colourants, sunscreens, and other
medications can provide additional, particular benefits. Bee wax and natural candelilla and
carnauba waxes are used to make lip balms.

History:
Historians claim that the ancient Egyptians were the first to discover natural oils, beeswax,
and honey, which are now utilised in lip balm. Cosmetics were only worn by the wealthy to
demonstrate their power and prestige. Cleopatra, who was born in 69 B.C., is possibly the
most famous Egyptian to use cosmetics such as lip balm
The invention of ChapStick can be traced back to ancient China. This is a one-of-a-kind piece
created exclusively for Different Truths. Since the dawn of time, people have devised cures
for chapped lips. According to Chinese sources, a type of lip balm was used as early as the
Eastern Han dynasty (25–220 AD). A cure for chapped lips for nursing moms is described.
anearly to mid-eighteenth-century American book.

Figure 1: Ancient Chinese Figure 2: Cleopatra 40 B.C.

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 1 Introduction

Lydia Maria Child, a woman named Lydia Maria Child, wrote a book called "The American
Frugal Housewife" in the 1800s. She also advocated using earwax to cure chapped lips in the
book!

Figure 3 :The American Frugal Housewife

The world's first official lip balm is claimed to Charles Brown Fleet in 1880s. It was covered
in tin foil and looked like a candle without a wick. Chapstick was the brand name, but it
didn't sell as well as the Chapstick we know today.

Figure 4: First Medicated Lip Balm Figure 5: First Lip Balm

Blistex lip care products were first introduced in 1947 by Charles Arch as a medicated lip
balm. It not only keeps your lips from drying out, but it also contains an external analgesic,
which acts as a pain reliever.

Abreva® was the first FDA-approved pharmaceutical over-the-counter lip therapy cream in
2000. This is used to treat more significant lip problems like cold sores.

Figure 6: First FDA approved Lip Therapy.

10

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 1 Introduction

Figure 7: Vintage Newspaper Ads of Lip Balms

Abstract:
Lip care products are an important aspect of everyday living. These provide the lips colour
while also protecting them from the elements. Lip balm's main purpose is to protect and
hydrate the lips. Lip care products come in a variety of shapes and sizes. The biggest issue
with this product is that it contains synthetic colourants and flavouring chemicals, which
might cause side effects such as lip darkening. Furthermore, these may include heavy metals,
which might harm numerous body organs. The current study looks at how to make lip balm
with as many natural elements as feasible, as well as how to evaluate the recipe. Beetroot
extract, cocoa powder, almond oil, and vitamin E were among the natural substances
employed.

11

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 2 Plan of Work

PLAN OF
WORK

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

 Chapter 2 Plan of Work

PLAN OF WORK:
1. Preformulation Study
2. Literature Review
3. Selection and Procurement of drug and excipients required for Lip Balm
4. Characterization of selected drug
I. Organoleptic properties
II. Solubility analysis
III. Melting point determination
5. Experimental Design
I. Construction of pseudo formulation.
II. Create a standard & stabilized formulation
6.Evaluation Parameters
I. Organoleptic properties
II. pH
III. Melting point
IV. Test for spreadability
V. Skin sensitivity
VI. Stability test

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 3 Literature Survey

LITERATURE
SURVEY

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 3 Literature Survey

Literature Survey:

• Kole PL, Jadhav HR, Thakurdesai P, Nagappa AN. Cosmetic potential of herbal
extracts. Nat Prod Radiance. 2005;4(4):315-21.

• Reiger MM. Harry's Cosmeticology, Volumes I-II: Chemical Publishing Company;

2000.

• Harry’s Cosmeticology edited by J.B.Wilkinson and R.J.Moore, Longman and

Technical Publishers ,(543-558)

• Cosmetics – formulation, manufacturing and QC by P.P.Sharma, 5th edition, Vandana

publication Delhi,(297)

• Pharmacognosy and phytochemistry , volume 2 –by Vinod D. Rangari , Carrier

publications,(138)

• Textbook of cosmetics, Rajesh Kumar Nema, Kamlesh Rathore, Bal Krishna Dube,
CBS publishers and distributors, (69) Easy. bird.in

• Handbook of Cosmetic science and technology,edited by Andreo Barrel ,Marc Paye

,Howard I. Maibach,Marcel Dekker, Inc.(680-681,770-772)
• BIS guidelines for lipsticks.

• COSMETICS: SCIENCE AND TECHNOLOGY, second edition, Volume I by

Marvin S.Balsam and Edward Sagrin. Chapter 12, Lipsticks by Paul. G.I. Lauffer.
(365-375).WILEY-INTERSCIENCE.

• COSMETIC TECHNOLOGY by Sanju Nanda, Arun Nanda ,Roop K .Khar,(70-77)

• HANDBOOK OF COSMETICS by B.M.Mitthal and R.N.Saha, (39-50), by Vallabh

Prakashan.

• The Chemistry and Manufacture of Cosmetics Volume II Formulating- Edited by

Mitchell L. Schlossman, Chapter 22 by Geoffrey Finkenaur,(629-657) ,Allured
Publishing Corporation.

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 4 Formulation Study

FORMULATION
STUDY

FORMULATION AND EVALUATION OF LIP LIGHTNING AND MOISTURIZING BALM

Chapter 4 Formulation Study

Materials Used:

Materials Used Manufacturer’s Name

Beetroot Powder Koko’s Naturals, Mumbai

White Soft Paraffin Analab Fine Chemicals, Mumbai

Hard Paraffin Analab Fine Chemicals, Mumbai

Lanolin Analab Fine Chemicals, Mumbai

Rose Oil Analab Fine Chemicals, Mumbai

Mentha Oil Analab Fine Chemicals, Mumbai

Vitamin E Procter & Gamble

Figure 8: Materials Uses.

17

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 4 Formulation Study

Choice Of Materials:

I. Beetroot:
a. Beetroot has bleaching qualities and is frequently used in lip balms to give lips
a properly coloured appearance. It will not only make your lips rosy pink, but i
t will also moisturise and nurture them.
b. It also aids in the removal of dry, chapped lips, leaving them smooth and
supple.
c. The beta-vulgaris in beetroot helps to lighten dark lips, but you must use it on a
daily basis to see results.

II. White Soft Paraffin:

a. White soft paraffin is only beneficial in this application if you want to improve
your skin's long-term state.
b. It is a moisturising emollient that is used to treat dry skin problems such as
eczema, pruritus, and ichthyosis.
c. It functions as a barrier cream by forming a layer of oil on the skin's surface
that prevents water from evaporating.

III. Hard Paraffin:

a. It works similarly to heat therapy in that it can assist enhance blood flow and
relax muscles.
b. It acts like hard base in the formulation.
c. It increases the elasticity of the skin.

IV. Lanolin:
a. Lanolin can help you save 20 to 30% on water loss through your skin.
b. It is incredibly moisturising and softening, which helps to improve the
appearance and feel of rough, dry, or flaky skin.
c. It lessens the appearance of wrinkles and fine lines.

V. Rose Oil:
a. Rose oil has antimicrobial properties.
b. It's anti-inflammatory qualities are really strong.
c. It allows more nutrients to be absorbed by your skin.

VI. Mentha Oil:

a. It gives relief from itching.
b. It gives soothing effect.
c. It neutralizes.

VII. Vitamin E:
a. It acts as a moisturiser
b. It acts as a antimicrobial agent.
c. It stabilizes the formulation.

FORMULATION AND EVALUATION OF LIP LIGHTNING AND MOISTURIZING BALM

Chapter 4 Formulation Study

Formulatory Steps:
I. Take Mortar pestle add beetroot powder, triturate it till
the beetroot powder is fine.
II. Add Rose oil & Mentha Oil and triturate it till it mixes
well.
III. Add White Soft Paraffin and lanolin and triturate them
well.
IV. Add Melted hard Paraffin to the pestle.
V. Mix it to form good pate like consistency.
VI. Refrigerate the paste like formulation for 6 hours.

Figure 9: During Formulation Process

19

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 4 Formulation Study

Composition of Lip Balm:

Ingredients Quantity Uses

Beetroot Powder 40 gm Anti-pigmentation agent

White Soft Paraffin 30 gm Moisturizer

Hard Paraffin 9.5 gm Moisturizer and Hard Base

Lanolin 9.5 gm Skin protecting Agent

Rose Oil 5 ml Flavouring & Masking Agent

Mentha Oil 5 ml Masking Agent & soother

Vitamin E 800 mg Antioxidant and stabilizer

Figure 10: Final Formulation of Lip Balm

20

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 5 Physiochemical Evaluation

PHYSIOCHEMICAL
EVALUATION

FORMULATION AND EVALUATION OF LIP LIGHTNING AND MOISTURIZING BALM

Chapter 5 Physiochemical Evaluation

• Organoleptic properties:
The formulation's physical appearance, colour, and odour were
investigated. Physical observation was used to assess these features. By
pressing a little amount of the formulation between the thumb and index
finger, texture and homogeneity were determined. The texture and
homogeneity of the formulations were assessed using the presence of
coarse particles and consistency. The stiffness, greasiness, and grittiness
of the skin were also assessed.

• pH:
One gram of formulation was dispersed and homogenised in 25 mL of
distilled water. A pH metre (Equi-Tronics) calibrated with a standard
buffer solution was used to determine the pH of the formulation (pH 4, 7
and 10). The measurements were made three times. The pH was found to
be 6.0[±0.5]

Figure 11: pH of the Formulation

• Melting Point:
The melting point equipment was used to determine the melting point. In
a nutshell, one end of the capillary was sealed, and the formulation was
injected into the capillary from another end up to a particular height. The
melting point device was used on the capillary, and the temperature at
which the bulk melted was recorded. The melting point was found to
be52°C[±3°C]

Figure 12: Melting Point determination

22

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 5 Physiochemical Evaluation

• Spreadablity Test:
Ceramic plates were used to test spreadability. Load was applied to the
formulation sandwiched between two plates, and the formulation was
dispersed over the plates. Visual inspection of the layer's formation
homogeneity was carried out.
For this test, the following criteria were established:
G - Good: uniform
I – Intermediate uniform; leaves few discontinuations
B - Bad: not uniform
The result of the test came out to be “G”.

Figure 13: Spreadblity Test

• Skin Irritation Test:

It was carried out by applying the product in the form of a patch on the
skin for 30 minutes and observes the reaction as
N- No reaction.
R- Redness of the skin.
I- Irritancy or itching.
It was applied on 20 different human skin types, nobody reported “R” or
“I”

Figure 14: Skin Irritation Test

23

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 5 Physiochemical Evaluation

• Stability Test:
The stability of the lip balm formulation was tested for 30 days at various
temperatures, including room temperature (25±2°C), higher temperature
in an oven (40±2°C), and refrigeration (5±2°C). On the 7th, 15th, and
30th days, characteristics such as organoleptic qualities and spreadability
were evaluated.
Stability data of lip balm formulation
Parameters Storage condition

Room temperature (25± 2±C) Refrigeration(5±2±C) Oven (40± 2±C)

7th d 15th d 30th d 7th d 15th d 30th d 7th d 15th d 30th d

Colour N N N N N N M M M
Odour N N N N N N N N N
Consiste N N N N N N M M M
ncy
Spreada G G G G G G B B B
bility
N-Normal, M-Modified, G- Good, B-Bad

• Microbial Testing:
Lip Balms gloss typically include Pseudomonas spp. and Staphylococcus
spp. The spread of Staphylococcus and Pseudomonas bacteria is
worrying, necessitating drastic measures.
The favoured media for growing Staphylococci cultures were tryptic soy
broth (TSB) and BHI. With aeration, cultures could not be grown at
37°C.

24

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 5 Physiochemical Evaluation

Result of Evaluation Tests:

Parameters Results

Colour Red

Organoleptic properties Good

pH 6.0[±0.5]

Melting Point 52[±3]

Spreadablity Test Good

Skin Irritation No Reaction

Stability Test Normal

Microbial Testing No culture developed

25

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 6

SUMMARY
AND CONCLUSION

FORMULATION AND EVALUATION OF LIP LIGHTNING AND MOISTURIZING BALM

Chapter 6 Summary & Conclusion

• Summary:
Lips have very thin skin and very susceptible to drying out, ultimately chipping
of lips takes place. Applying lotions and creams on chipped lips are impractical
as these are water-soluble have very little retention on lips. Ointments suffer
from stickiness; hence lip balm is the best alternative to apply on lips. Lip balm
retains the moisture and prevents chipping. Synthetic dyes, flavours and other
ingredients may harm lips as these may cause drying of lips, allergic reaction
and darkening. The current research work aims to prepare lip balm containing
the maximum possible herbal ingredients. To impart the attractiveness to lips as
well as to enhance the aesthetic appeal of the cosmetic formulation selection of
colouring agents is of utmost importance. In this formulation, the colouring
agent was used as beetroot pigments. The beetroot is an easily available
resource of red colour pigments. These pigments are known as betalains. These
consist of betaxanthines which responsible for the yellow colour and
betacyanins produce the red colour. The major constituent of betacyanins is
betanin that accounts for 75-95%, which imparts red colour to beetroot.
Retention of colour pigments is important for the visual appeal of the
formulation. The current study is also focused to impart a red colour to the
formulation; hence beetroot is selected as a major source of colour pigment. In
addition to that betanin also possess antioxidant potential and found to constrain
lipid peroxidation.
Besides, vitamin E is added as antioxidant to prevent oxidation of formulation.
Vitamin E also helps to make lips softer and more resistant to damage. Cocoa
powder is one of the key excipients in food and pharmaceuticals. In this
formulation, Rose Oil is used as a natural flavouring agent. The flavour is a
significant parameter for the consumer. The Rose flavour is natural,
characteristic and attractive. Rose oil & Mentha oil contains volatile
constituents such as esters, pyrazines, aldehydes, organic acids, and
diketopiperazines that impart aroma. Cocoa also composed of alkaloids like
methylxanthine, proteins and carbohydrates. Reducing sugar and protein that
interacts through Millard reaction that yields a characteristic chocolate-like
flavour. Almond oil used as a moisturizing and emulsifying agent. It contains
fatty acids that retain moisture in the skin and promote healing of chapped lips.
The emollient property helps to keep the lip soft and smooth. Besides Rose And
Mentha Oil rejuvenates lips by removing dead skin cells and lightens lips. By
considering the various advantages of natural ingredients lip balm formulation
was prepared.

27

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 6 Summary & Conclusion

• Conclusion:
The demand for natural Lip Balms is growing day by day, present study
showed Beta vulgaris contains nutrients, vitamins and Betanin which are
responsible for colouring effect and moisturizing. Further the result of the
present study demonstrated that Beta vulgaris is one of the vulgaris species
that merits more investigation and research.

• FUTURE SCOPE:
§ Animal Friendly
§ Less Adverse Reaction
§ Less Chemical Waste

28

FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM

Chapter 7 Reference

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FORMULATION AND EVALUATION OF LIP LIGHTNING AND MOISTURIZING BALM

Chapter 7 Reference

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Chapter 7 Reference

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Chapter 7 Reference

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Spectrophotometry, physiochemical properties, and histological staining

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Chapter 7 Reference

potential of aqueous and ethanol extracts of beetroot on various tissues of

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Chapter 8 ERRATA

ERRATA

FORMULATION AND EVALUATION OF LIP LIGHTNING AND MOISTURIZING BALM

Chapter 8 ERRATA

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Chapter 8 ERRATA

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FORMULATION AND EVALUATION OF LIP LIGHTNINGAND MOISTURIZING BALM