Sunscreen Preparation Project Work 8 Sem.

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SUNSCREEN PREPARATION

A
PRACTICE SCHOOL REPORT
SUBMITTED FOR

B.N. UNIVERSITY,UDAIPUR

SESSION – 2023-24

FOR THE PARTIAL FULFILMENT OF

BACHELOR OF PHARMACY
(SEMESTER-VIII)
COURSE NAME: PRACTICE SCHOOL
COURSE CODE: BP812PS

SUPERVISED BY:- SUBMITTED BY:-


Dr.Chetan Singh Chauhan Nishant Saxena
Principal, Roll No.:- 2149458
BNIPS, Udaipur Enrollment No.:-20/9458

BHUPAL NOBLES’ INSTITUTE OF PHARMACEUTICAL SCIENCES,


B.N. UNIVERSITY, UDAIPUR-313001 (RAJASTHAN)
FORWARDING CERTIFICATE

This is to certify that NISHANT SAXENA student of B.Pharm


Seventh Semester of this college has worked on the project entitled
“SUNSCREEN PREPARATION” under my guidance and
supervision.

He has worked hard meticulously and methodically. I wish every


success in future endeavours and recommend that this project work to
be forwarded for evaluation.

I wish every success in his life.

Place: Udaipur Dr. Chetan Singh Chauhan

Date: Principal,
BNIPS, Udaipur
DEDICATED

to

My Beloved Parents

for this uncompromising principles

that guides my life

My Loving Brother and Sister

for always motivating me for all in my life

My Honourable Teachers

for all that I am today and

shall be through my life

And

My Profession
CANDIDATE'S DECLARATION

I hereby declare that the work, which is being presented in the B. Pharmacy,
VIII semester project report entitled "SUNSCREEN PREPARATION"
towards the partial fulfillment of the requirement for award of the degree of
Bachelor of Pharmacy submitted in the Department of Pharmacy, B.N.
Institute of Pharmaceutical Sciences, Udaipur is an authentic record of my
own work carried out, under the guidance of Dr. Chetan Singh Chauhan ,
Principal, B.N. Institute of Pharmaceutical Sciences, Udaipur.

Nishant Saxena

B. Pharm (VIII Semester)

Enrollment No. : 20/9458


ACKNOWLEDGEMENT
“Success is the sweetest flower in the garden of hard work”

First of all I would like to thank Dr.Chetan Singh Chauhan, Principal, B.N. Institute Of
Pharmaceutical Sciences, Udaipur for his immense support and encouragement.

I would also like to express my sincere gratitude to my guide Dr.Chetan Singh Chauhan,
B.N. Institute Of Pharmaceutical Sciences, Udaipur for this encouragement, constant
inspiration, creative and constructive criticism, whole hearted support and extending all
the possible help. His expert guidance, advice, timely suggestions, explicit decision and
deep personal interest has been privilege for me. He has been a perennial source of
inspiration for this project.

Words would be limited in expressing my heartful veneration to my Father and Mother


for their emotional support, motivation, inspiration in boosting my moral without which I
have been in vain.

Sky is the limit to express a deep sense of gratitude to all my friends who have made
more interesting that it could have been.

Last but not the least I would like to thank to my entire colleagues for their recent useful
matters, ideas and discussion over the period of time that helped me to broad my concept
to complete this project work.

Place:Udaipur Nishant Saxena

Date:
CONTENT
Sr. No. Particulars Page no.
Chapter 1 Introduction 1-4
UVA and UVB 3-4
Sun Protection Factor 4
Chapter 2 History 5-7
Background of the Invention 6
Description of Related Art 7
Chapter 3 PHYSIOLOGY OF SKIN 8-14
Epidermis 9-10
Dermis 11
Blood vessels 12
Sensory Nerve Endings 12
Sweat glands 13
Hairs 13
The Arrestor Pill 14
The Sebaceous Glands 14
Chapter 4 PROTECTION MECHANISM OF SKIN 15-16
Chapter 5 PRINCIPLE OF EFFECTIVENESS OF 17-19
SUNSCREEN
Chapter 6 SUNBURN PREPARATION 20-22
Palliative Preparation 21
Simulative Preparation 21-22
Chapter 7 SUNSCREEN PREPARATION 23-43
Sunscreen 24-27
Types of sunscreen 27-28
General Procedure for manufacturing of sunscreen 28-32
preparation
Active Ingredients 33-41
Mechanism Of Action Of Sunscreen Preparation 41
Adverse Effect Of Sunscreen Preparation 41-42
Different types of Sunscreen Products 42-43
Chapter 8 REGULATIONS AND STANDARD OF 44-46
SUNSCREEN
Chapter 9 EVALUATION 47-49
Chapter 10 Conclusion 50-51
References 52-54
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SUNSCREEN PREPARATION

CHAPTER-1

INTRODUCTION

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[1] INTRODUCTION:
Sunscreens are a preventive health practice that is safe, economical and which
can greatly reducen your chances of developing skin cancer. Sunscreens will
lower your risk of skin cancer and protect your skin from looking weathered
and aged before its time.
Many individuals do not feel they appear vital and healthy unless they have a
suntan. It is nearly impossible to reverse the signs of early aging. Expensive
lotions, creams and vitamins wil not rejuvenate skin that has been tanned for
numerous years and damaged.

Recent studies show that UV light causes DNA mutations ot occur in the skin.
These mutations lead to cancer. Exposure ot the sun thickens the skin and a tan
is a sign of sun-injury. Sunscreen can protect the skin from these harmful
effects.

Individuals who have light complexions


should use a sunscreen with a protection of
at least 30. Other individuals should use a
sunscreen with at least a protection level of
15. All sunscreens should state they protect
against UVA and UVB rays. No matter the
degree of protection you are using, if you do
not apply it correctly it wil not protect your
skin adequately. Sunscreen should be
applied at least one-half hour before sun
exposure.[21]

The presence of ultraviolet (UV) filters in skincare and cosmetic products


represents a key benefit that cosmetics can provide consumers. The hazards of
UV light exposure are well known. It is estimated that the incidence of no
melanoma skin cancer in the United States exceeds one milion cases per year[5]

UV-induced or photo aging accounts for 80% to 90% of visible skin aging.[6]

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UV radiation damages the skin by both direct effect on DNA and indirectly on
the skin's immune system.[7]
In animal models, sunscreens prevent the formation of squamous cell
carcinomas of the skin.[8] The regular use of sunscreens has ben shown to
reduce the number of actinic or precancerous keratosis[9] and solar elastosis.[10]
Sunscreens also prevent immunosuppressant " Double-blind photo agnig
studies show consistent improvement in the "untreated" control groups partly
because of the use of sunscreens by all study subjects.[12]
A well-designed sunscreen does two things: It blocks harmful ultraviolet (UV)
rays and Callows the skin to
Jan. UV rays carry high
energy and are suspected to
cause cancer by damaging
DNA. In addition, excess
UV exposure causes
increased wrinkling of the
skin.[1]
[1.1] UVA and UVB:-
The two main kinds of
ultraviolet light emitted by the sun are UVA (Ultra- Violet A) and UVB (Ultra-
Violet B). Sunscreens are applied to protect the skin against these rays.
1. UVA (Ultra-Violet A): are the sun's rays that penetrate the skin deeply. They
are the principal causes of wrinkles and sun-induced aging. While they do not
often cause sunburn, some recent research indicates that UVA sometimes
increases UVB's cancer-causing effects, and also causes skin cancer.

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.
2. UVB (Ultra-Violet B) is the suns rays that strike the surface of the skin and
therefore cause sunburn. They are considered the major cause of skin cancers.

[1.2] Sun Protection Factor:-

SPF or Sun Protection Factor is the time that protected skin would take to
burn as compared ot an unprotected skin expressed as a number/For
example, if a person whose skin burns after 10 minutes exposure ot the sun
wore a sunscreen with an SPF of 3, ti would take him 30 minutes to start to
burn. If he wore a sunscreen with SPF60, it would now take him 60 times the
original amount of time for him to start to bum i.e. 60 minutes

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CHAPTER-2

HISTORY

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[2] HISTORY:-
 In 1979, hte American Fod and Drug Administration (FDA) declared that
wearing sunscreen could help prevent skin cancer.
 It was at this time that they also came up with a system of Sun Protection
Factor (SPF) rating system that helped grade the level of sun protection
that a product provided ni numerical terms.
 This was folowed up the American Academy of Dermatology's (AAD)
large scale education campaign about using sunscreens ot prevent skin
cancers.
 This jumpstarted an entirely new range of cosmetic products, and today
sun protection forms an enormous segment of the cosmetic industry.

[2.1] BACKGROUND-

1. Background of the Invention-


The present invention relates generally to a sunscreen preparation of
modifiable high screening capability and, more particularly, to such a
preparation which is quick drying after topical application to the skin and does
not have either tacky or slippery consistency but instead quickly leaves the skin
dry, smooth and soft.

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2. Description of Related Art-


The medical profession has been stating for many years with increasing
emphasis that exposure of the human skin to the rays of the sun is dangerous
and tends to produce skin cancer if continued. This dangerous condition is
exacerbated in certain types of individuals who are more susceptible to skin
damage from solar radiation than others and, accordingly, it has been suggested
that when individuals are to be in the sunlight for any significant period' of
time, that they not only wear proper clothing to block out the sun's rays from
major skin surfaces, but also ot protect exposed parts of the body (e.g., the
face, neck, hands and arms) by topical application of a cream or other
preparation that contains a block or screening material ot reduce the amount of
radiation reaching hte skin.[24]

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CHAPTER-3

PHYSIOLOGY OF
SKIN

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[3] Physiology Of The Skin-

The skin is [the largest organ in the body and has a surface area of about 1.5 to
1m2 in adults and it contains glands hair and nails. There are two main layers:

Epidermis
Dermis
Between the skin and underlying structures is a layer of subcutaneous fat.

[3.1] Epidermis-

The epidermis is the most superficial layer of the skin and is composed of
stratified keratinized squamous epithelium which varies in thickness in
different parts of the body. It is thickest on the palms of the hands and soles of
the feet. There are no blood vessels or nerve endings in the epidermis, but its
deeper layers are bathed in interstitial fluid from the dermis, which provides
oxygen and nutrients, and is drained away as lymph.

There are several layers (strata) of cells in the epidermis which extend from the
deepest germinative layer the surface stratum cornier (a thick horny layer). The
cells on the surface are flat, thin, nun-nucleated, dead cells, or squamous, in
which the cytoplasm has been replaced by the fibrous protein keratin. These
cells are constantly being rubbed off and replaced by cells that originated in the
germinative layer and have undergone gradual change as they progressed
towards the surface. Complete replacement of the epidermis takes about a
month.

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The maintenance of healthy epidermis depends upon three processes being


synchronized: desquamation a motion (shedding) of the keratinized ceils from
the surface, effective keratinisation of the cells approaching the surface.
continual cel division ni the deeper layers with newly formed ceils being
pushed to the surface.

Hairs, secretions from sebaceous glands and ducts of sweat glands pass through
the epidermis to reach the surface.

The surface of the epidermis is ridged by projections of cells in the dermis


called papillae. The pattern of ridges is different in even' individual and the
impression made by them si the 'fingerprint. The downward projections of the
germinative layer between the papillae arc believed to aid nutrition of
epidermal cells and stabilize the two layers, preventing damage due to shearing
forces. Blisters develop when trauma causes separation of the dermis and
epidermis and serous fluid collects between the two layers.

Skin color is affected by various factors.

• Melanin, adark pigment derived from the amino acid tyrosine


and createdbymelanocytesinthe deep germinative layer, is absorbed by
surroundingepithelialcells.The amount is genetically determined and
variesbetweendifferentpartsofthe body, between people of the same ethnic
reign and between ethnic groups. The number of melanocytes I fairly
constantsothedifferencesincolordependon the amount of melanin
secreted. It protects the skin from the harmful effects of sunlight. Exposure to
sunlight promotes synthesis of melanin.
• The percentage saturation of hemoglobin (p. 60) and the amount of blood
circulating in the dermis give white skin its pink color.
• Excessive levels of bile pigments ni blood and carotenes ni subcutaneous fat
give the skin a yellowish color.

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[3.2] Dermis:
-
The dermiss is tough and elastic. It is formed from connective tissue and the
matrix contains collagen fibers interlaced with elastic fibers. Rupture of elastic
fibers occurs when the skin is overstretched, resulting in permanent striae, or
stretch marks, that may be found ni pregnancy and obesity. Collagen fibers
bind water and give the skin its tensile strength, but as this ability declines with
age, wrinkles develop.
Fibroblasts, macrophages and mast cels aer the main cels found ni the dermis.
Underlying its deepest layer there is areola tissue and varying amounts of
adipose (fat) tissue. The structures in the dermis are:
• Bloodvessels
• Lymph vessels
• sensory (somatic) nerve ending
• sweat glands and their ducts
• Hairs, arrestor pill muscles and sebaceous glands.

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Blood vessels-

Arterioles form a fine network with


capillary branches supplying sweat
glands, sebaceous glands, hair follicles
and the dermis. The epidermis has no
blood supply. It obtains nutrients and
oxygen from interstitial fluid derived
from blood vessels in the papillae of the
dermis.
Lymph vessels: These form a network
throughout the dermis.

Sensory nerve endings-


Sensory receptors (specialized nerve
endings) sensitive to touch, temperature,
pressure and pain are widely distributed
ni the dermis. Incoming stimuli activate
different types of sensory receptors. The
skin is an important sensory organ
through which individuals receive
information about their environment.
Nerve impulses, generated in the sensory
receptorsin the dermis, are conveyed to
the spinal cord by sensory (somatic
cutaneous) nerves, then to the senson'
area of the cerebrum where the sensations
aa'perceived.

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Sweat glands-

Sweat glands are widely distributed throughout the skin and are most numerous
in the palms of the hands, soles of the feet, axillae and groins. They are
composed of epithelial cells. The bodies of the glands lie coiled in the
subcutaneous tissue. Some ducts open onto the skin surface at tiny depressions,
or pores, and others open into hair follicles. Glands opening into hair follicles
do not become active until puberty. In the axilla they secrete a colorless milky
fluid which, if decomposed by surface microbes, causes an unpleasant odor.
The functions of this secretion are not known. Sweat glands are stimulated by
sympathetic nerves in response to raised body temperature and fear.
The most important function of sweat secreted by glands opening on to the skin
surface is in the regulation of body temperature. Evaporation of sweat from
body surfaces takes heat from the body core and the amount of sweat produced
is governed by the temperature-regulating centre in the hypothalamus.
Excessive sweating may lead to dehydration and serious depletion of sodium
chloride unless intake of water and salt is appropriately increased. After 7 to 10
days' exposure to high environ- mental temperatures the amount of salt lost is
substantially reduced but water loss remains high.

Hairs-

These are formed by a down-growth of epidermal cells into the dermis or


subcutaneous tissue, called hair follicles. At the base of the follicle is a cluster
of cells called the bulb? The hair is formed by multiplication of cells of the
bulb and as they are pushed upwards, away from their source of nutrition, the
cells die and become keratinized. The part of the hair above the skin is the shaft
and the remainder, the roof.

The colour of the hair is geneticaly determined and depends on the amount of
melanin present. White hair is the result of the replacement of melanin by tiny
air bubbles.

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The Arrestor Pili:-

These are little bundles of smooth muscle fibers attached to the hair
follicles.Contraction makes the hair stand erect and raises the skin around the
hair, causing ‘goose flesh'. The muscles are stimulated by sympathetic nerve
fibers in response to fear and cold. Erect hairs trap air, which acts as an
insulating layer. This is an efficient warming mechanism especially when
accompanied by shivering, i.e. involuntary contraction of skeletal muscles.

The sebaceous glands-


These consist of secretary epithelial cells derived from the same tissue as the
hair follicles. They secrete an oily substance, sebum, into the hair follicles and
are present in the skin of all parts of the body except the palms of the bonds
and the soles of the feet. They are most numerous in the skin of the scalp, face,
aillae and groins. In regions of transition from one type of superficial
epithelium to another, such as lips, eyelids, nipple, labia minora and glans
penis, there are sebaceous glands that are independent of hair follicles,
secreting sebum directly onto the surface.
Sebum keeps the hair soft and pliable and gives it a shiny appearance. On the
skin it provides some waterproofing and acts as a bactericidal and fungicidal
agent, preventing infection. It also prevents drying and cracking of skin,
especially on exposure to heat and sunshine. The activity of these glands
increases at puberty and is Iess at the extremes of age, rendering infants and
older adults prone to the effects of excessive moisture.[3]

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CHAPTER-4

PROTECTION
MECHANISM OF
SKIN

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14] Protection Mechanism of the Skin:-


Mainly two factors are responsible for natural protection of skin against
sunbum.

(1) Thickness of the stratum corneum

(2) Pigmentation of the skin

It bas been reported that thickening of the stratum corneum occurs due to effect
of solar irradiation by increasing mitotic rate of epidermal cells and thus
making it more impervious to the passage of erythemogenic radiation.

Increase in melanin content of the epidermis also increases the protection


power of the skin. UV radiation causes excess formation of melanin which
migrates upward towards stratum corneum and the skin surface and thus
increases the resistance. Suntan preparations only facilitate this excess
formation of melanin.[2]

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CHAPTER-5

Principle Of
Effectiveness Of
Sunscreen

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[5] Principle of Effectiveness of Sunscreens:-

It is a fact that the exposure of unprotected skin to sunlight not only produces
the desired therapeutic effect but also results in sunburn and the subsequent
peeling oft of the comeal layer is a cosmetic problem. In principle, this
problem can be treated in different ways.

(1) A protective layer can be provided to the skin that prevents the UV-rays to
reach the skin either by absorbing or by reflecting them. Some of the materials
used in powders do actually reflect a certain amount of UV-rays and are thus
incorporated in suntan preparations.
Zinc oxide and titanium dioxide both have such property but the former is
better than the latter. Preparations reflecting UV-rays are very effecttive and
used widely. However, these preparations have the disadvantage of eliminating
the beneficial rays along with the harmful ones.

(2) To incorporate substances in preparations to filter the sun-rays by absorbing


medium range UV-rays (280 mu.-320 mu.) but allowing rays of higher wave
lengths to pass. All modern suntan preparations are based on this principle and
contain such substances.

(3) Biologically effective substances can be used effectively to prevent


symptoms of inflammation without reduction of tanning. As already mentioned
earlier that damage of the cells by sunburn liberates histamine in the tissues,
attempts have been made to treat it with antihistaminic
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SUNSCREEN PREPARATION

substances to avoid inflammation. Because of their anti-inflammatory action,


hydrocarbons and fluorocarbons may be useful in treating sun burn but they are not
recommended in suntan preparations.

(4) Substances that cause or accelerate tanning ot the skin can be applied. Dioxyacetone
causes tanning by forming a brown complex with the keratin of the corneal layer. 8-
methoxypsoralene when taken 10-20 mg internally 2 hours before exposure to the sun,
accelerates tanning and avoids sunburn.[2]

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CHAPTER-6

SUNBURN
PREPARATION

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[6] SUNBURN PREPRATION:-


Cosmetic sunburn and suntan
preparations may be classified
into three groups:
[6.1]Palliatives preparations
[6.2]Simulative preparations
[6.3] Sunscreen preparation

[6.1] Palliative Preparations-


These preparations are used for
the relief of irritation and other
problems resulting from sunburn. As sunburn causes damage to skin cells, in
several cases it can be as serious as steam burn; there is always a possibility of
secondary bacterial infection. So, all these preparations should also be
antiseptic. Palliative preparations are either aqueous solutions or oil-in-water
emulsion and should be able to produce both protective and cooling effect to
relieve the sunburn. These preparations should not be greasy or oily because
they will retard the antiseptic effect as the antiseptics will not be able to mix
with secretions to prevent bacterial growth

[6.2] Simulative Preparations-


They are also termed as artificial suntan preparations, good demand of such
preparations to obtain a suntan, The purpose of enhanced color may

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be to prevent skin damage by absorption of erythemal radiation or to indicate the well-


being of the health, artificial suntan normally is obtained by staining of the skin, whatever
may be the purpose.

Though several natural materials, like walnut iuice olive oil extract or cudbear and henna,
were used from ancient tin skin stain, they are not favorable nowadays. Now mainly
synthetic materials are used.[2]

A Systemic suntan

B Staining preparation

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CHAPTER-7

SUNSCREEN
PREPARATION

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[7] SUNSCREENS-
Sunscreens are substances that protect the skin from harmful effects of
exposure to sunlight.[4]
These are the most important group of preparations. Sunscreens should either
scatter the incident light effectively, or they should absorb the erythemal
portion of the sun's radiant energy. Various factors other the duration of
exposure are also to be taken into account. For example background is
important. Snow has a better effect on the individual as it reflects a higher
proportion of ultraviolet radiation than sand. Opaque powder materials, either
used in dry state or in a vehicle, will serve ot scatter the ultraviolet light falling
upon them. Among them zinc oxide is most effective and superior to titanium
dioxide. Other less effective substances are kaolin, calcium carbonate,
magnesium oxide, talc etc. Particle size of these substances in these
preparations is also an important factor.

The ideal sunscreen agent should have the following characters—


(1) Absorb light preferentially over the range of 280 mu-320 mu.
(2) Be stable to heat, light and perspiration.
(3) Benon-toxicand non-irritant.
(4) Not be rapidly absorbed.
(5 )Beneutral.
(6) Be readily soluble in suitable vehicles.

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There are numerous substances which are suitable for use as Sunscreens:
(1) Para-amino benzoic acid, its derivatives and glyceryl esters, like ethyl Para
amino benzoate, glyceryl Para-amino benzoate, etc.
(2) Salicylate, like amyl salicylate, phenyl salicylate, benzyl, menthyl, glyceryl,
etc.
(3) Cinnamic acid derivatives, like benzyl cinnamate, menthy! cinnamate, etc.
(4) Dihydroxy Cinnamic acid derivatives.
(5) Trihydroxy Cinnamic acid derivatives.
(6) Certain hydrocarbons.
(7) Dibenza Iacetone and benzalacetophenone.
(8) Dihydroxy-napthoic acid and its salts.
(9) Coumarin derivatives.
(10) Diazoles and triazoles.
(11)Quinine salts.
(12)Quinine derivatives.
(13) Uric and viol uric acids.
(14) Tannic acid derivatives.
(15) Hydroquinone etc.
Some othercompounds alsohave been reported to be effective sun screens.
They are hydrazines of ortho- or para-aminobenzaldehyde, and of ortho- and
para-aminoacetophenones.

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Also acetyated amino- cinnamate, a reaction product of carbethoxyethyl-


triethoxysilane with p- amino benzoic acid, has ben reported ot be useful as
sunscreen.
As all the above substances are of low molecular weight, they are quickly
removed from the skin with water, necessitating repeated application. This led
to the development of water-insoluble but alkali-soluble polymeric sunscreens.
These polymers are produced by reacting at least two essential co-monomers.

(1) An ethylenically unsaturated compound, capable of absorbing ultraviolet


radiation, like certain substituted acrylates. Methacrylates, benzoates, ethers of
2, 4-dihydroxybenzophenone.2, 2, 4- trihydroxybenzophenone, and ethers of
benzotriazolederivatives.

(2) An acidic co-monomer, an ethylenically unsaturated carboxylic acid


containing at least one free carboxyl group methacorylic acid, itaconic acid,
crotonic acid, etc.
like acrylic acid,
These polymericsunscreens have been found to be resistant to removal by fresh
or sea-water. But they can be removed easily Fay a slightly alkaline solution
like soap-water which converts water-insoluble polymer to water-soluble
alkaline salts due to presence of free carboxylic acid group.
Different sunscreen agents are used in different concentration according to
their efectiveness. Some are used in higher concentrations 6-8% and others at
low concentrations like 2%.
Suitable base can be used to make a final product of na aqueous alcoholic
lotion, a faty cream, oil, or an emulsion. The vehicle and selection of other
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SUNSCREEN PREPARATION

components of the product may contribute ot its efectiveness. Certain natural


oils such as coconut oil, peanut oil muster-seed oil and olive oil have a fairly
high absorption ability of UV; light, but mineral oil does not have such
property. An antioxidant is to be incorporated if natural oil is used to prevent
rancidity.
Effective bases can be prepared by using mixtures of natural oils mineral
oils, or by blending these with faty acid esters such as iso- propylpalmitate.
Some effective protection from sunburn is also provided by white or yelow
petroleum jelly and lanolin. All these preparations contain some perfume and
preservative, if required occasionaly colors are also used.[2]

[7.1] TYPES OF SUNSCREEN-


Two types of sunscreen are available:-
[l] 'Physical Blockers:-
Sunscreens that arephysical blockers titanium dioxide
and zinc oxide work by reflecting UV radiation.
Physical blockers are effective against both UVA and
UVB radiation. They are made of internal metals that
sit on the skin and are not absorbed. Physical blockers
do not wear off as quickly as chemical blockers, but
they aer more susceptible to washing of the skin from water or sweating.

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[2] Chemical blockers:-


Sunscrens that are chemical blockers absorb VU
radiation within aspecific wavelength. The
benzophenones (oxybenzone,sulisobenzone,
dioxybenzone), menthyl anthranilate, and
avobenzone are chemical blockers that protect
against both UVA and UVB radiation.
The product of sunscreen can be simple
manufacture in oil type, cream type, lotion type,
aqueous solution type, gel type.

[7.2] General Procedure for Manufacturing Of


sunsereen preparation:-

[1] Oil type sunscreen preparation


General Procedure for Manufacturing
Oily type sunscreen preparation can be prepared
simply by mixing and dissolving the sunscreen
and other ingredients in the vehicle, i.e., water or
oil. Perfume should be added all of last.
OIL TYPE
Formula 1-
Homomenthyl salicylate 8.0 gm
Mineral oil 92.0 gm
Perfume q.s.
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Formula 2-
Homomenthyl salicylate 8.0 gm
Mineral oil 80.0 gm
Isopropyl myristate 12.0 gm
Perfume q.s.

Formula 3-

Isopropyl myristate 90.0 gm


Antiviray 10.0 gm
Perfume q.s.
Colour q.s.
Preservative q.s.

Isopropyl myristate may be replaced by isopropyl palmitate. Prepa ration is


simply by solution technique. Mix the perfume, color preservative with
isopropyl myristate and sunscreen agent with oil and mix both together.

[2] Cream type sunscreen preparation


General Procedure for Manufacturing
Cream preparations are emulsion type and are
prepared by taking ingredients
of oil phase and aqueous phase separately and
heating to liquefy or dissolve all
ingredients and then mixing them together with
continuous stirring till the cream is produced.
Perfume should be added after cooling the
cream to near room temperature and milling
further.
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SUNSCREEN PREPARATION

CREAM TYPE
Formula 4-
A. Homomenthyl salicylate 8.0 gm
Non-ionic emulsifier (tween) 7.5 gm
Mineral oil 2.0 gm
Spemaceti 5.0 gm
B. Glycerin 5.0 gm
Water 72.50 gm
Perfume q.s.
Methyl parahydroxy benzoate q.s.
Propyl parahydroxy benzoate q.s.
Formula 5-
A. Antiviray 8.0 gm
Stearic acid 1.7 gm
Isopropyl myristate 6.0 gm
Abracol PGS (emulsfying agent) 3.5 gm
B. Triethanolamine 0.8 gm
Water 80.0 gm
Perfume q.s.
Preservative q.s.
Colour q.s.
Formula 6-
A. Antiviray 5.0 gm
Tween 7.5 gm
Cetyl alcohol 1.0 gm
Isopropyl myristate 15.0 gm
Mineral oil 17.0 gm
B. Glycerin 1.0 gm
Water 54.5 gm
Perfume q.s.

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Lotions type sunscreen preparation

General Procedure for. Manufacturing


Lotions can be solutions or emulsion type and can be
prepared accordingly.
Gels are ehighly viscous s aqueous preparations.
Thickening agent is dispersed in water sepparately. Other
ingredients are mixed together and dissolved in
then the dispersion of thickening agent is mixed with
others with water. Then the dispersion of thickening agent
is mixed with stiring to prepare gel.

LOTION TYPE

Formula 7-

Isopropyl myristate 2.0 gm


Antiviray 10.0 gm
Toilet spirit 88.0 gm
Perfume q.s.
Colour (alcohol-soluble) q.s.

Dissolve antiviray in isopropyl myristate. Dissolve perfume and colourin spirit


and mix both.

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SUNSCREEN PREPARATION

Formula 8-

A. Filtrosol A 1000 5.0 gm


Mineral Oil 10.0 gm
Stearic acid 2.0 gm
Paraffin wax 1.0 gm
Beeswax 2.0 gm
Petroleum jelly 5.0 gm
Silicone fluid 8.0 gm
Polyethylene glycol monostearate 5.0 gm
B. Triethanolamine 2.0 gm
Water 60.0 gm
Perfume q.s.
Preservative q.s.

Heat ingredients of 'A' ot a temperature of about 70°C. Heat ingredients of 'B'


to same temperature and ad slowly ot the mixture of A' .' Stir until cool. Ad
perfume when the temperature comes down ot about 35°C.[2]
.

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SUNSCREEN PREPARATION

[7.3]Active Ingredients:-[25,26]

The principal ingredients in sunscreens are usually aromatic molecules


carbonyl groups. This general structure allows the molecule conjugated with
absorb high-energy ultraviolet rays and release the energy as lower-energy
ys, thereby preventing the skin-damaging ultraviolet rays from reaching the
skin. So, upon exposure to UV light, most of the ingredients (with the notable
exception of benzone) do not undergo significant chemical change, allowing
the ingredients to retain the UV-absorbing potency without significant
photodegradation! J^yV chemical | stabilizer is included in some sunscreens.

FDA allowable ingredients in sunscreen prepration:-

The following are the FDA allowable active ingredients in sunscreens:

Known
Maximu
permitti
m Results of UV UV
UV-filter Other names ng
concentra safety testing A B
jurisdict
tion
ions

15% Protects
(USA), against skin
(EU: tumors in
p- banned mice. Shown
Aminobenzoic PABA from sale USA to increase X
acid to DNA defects,
consumers and
from 8 not generally
October recognised as

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SUNSCREEN PREPARATION

2009) safe and


effective acco
rding to
the FDA

8% (USA,
AUS)
OD-PABA, 10% (JP) EU,
octyldimethy USA, X
Padimate O (Not
l-PABA, σ- currently AUS, JP
PABA supported
in EU and
may be
delisted)
4% (USA,
Phenylbenzimi EU,
Ensulizole, AUS) 8% Genotoxic in
dazole sulfonic USA, X
PBSA (EU) 3% bacteria]
acid AUS, JP
(JP)

2-
Ethoxyethyl
3% (USA) USA,
Cinoxate p- X X
6% (AUS) AUS
methoxycinn
amate

Benzophenon USA,
Dioxybenzone 3% (USA) X X
e-8 AUS

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SUNSCREEN PREPARATION
6%
Banned in
(USA),
Hawaii since
2.2%
Oxybenzon EU, USA, 2018 "harmful
Benzophenone-3 (body) / X X
e AUS to coral reefs,
6% (face)
fish, and other
EU,[103] 1
ocean life"
0% AUS,

7.34%
Homomethyl (EU) 15% EU, USA,
Homosalate X
salicylate (USA, AUS
AUS)

Menthyl 5% USA,
Meradimate X
anthranilate (USA) AUS

Eusolex OCR,
Parsol 340, 2- Increases reac
Octocrylen 10% EU, USA,
Cyano-3,3-diphenyl tive oxygen X X
e (USA) AUS
acrylic acid, 2- species (ROS)
ethylhexylester

Octyl-
methoxycinnamate, 7.5% Banned
Ethylhexyl (USA) in Hawaii sinc
EU, USA,
Octinoxate methoxycinnamate, 10% (EU, e 2021 - X
AUS, JP
2-Ethylhexyl- AUS) harmful
paramethoxycinnam 20% (JP) to coral
ate

Octisalate, 2- 5% (EU,
Octyl EU, USA,
Ethylhexyl USA, X
salicylate AUS, JP
salicylate AUS)

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SUNSCREEN PREPARATION

10% (JP)

2-Hydroxy-4-
Methoxybenzophen
one-5-sulfonic acid, 5% (EU)
Sulisobenz 3-Benzoyl-4- 10% EU, USA,
X X
one hydroxy-6- (USA, AUS, JP
methoxybenzenesul AUS, JP)
fonic acid,
Benzophenone-4

1-(4-
methoxyphenyl)-3-
3%
(4-tert-butyl
Avobenzon (USA) EU, USA,
phenyl)propane-1,3- X
e 5% (EU, AUS
dione, Butyl
AUS)
methoxy
dibenzoylmethane,

EU, AUS
(US:
approved
in certain
Protects
Terephthalylidene formulati
against skin
Ecamsule Dicamphor Sulfonic 10% ons up to X
tumors in
Acid 3% via
mice
New Drug
Applicati
on (NDA)
Route)

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SUNSCREEN PREPARATION
EU,
25% (US)
Titanium CI77891, USA, Generally recognized as safe
No limit X
dioxide TiO₂ AUS, and effective by the FDA
(JP)
JP

EU, Generally recognized as safe


25% (US)
Zinc CI77947, USA, and effective by
No limit
oxide ZnO AUS, the FDA. Protects against
(AUS, JP)
JP skin tumors in mice

Zinc oxide was approved as a UV filter by the EU in 2016. Other ingredients


approved within the EU and other parts of the world, that have not been
included in the current FDA Monograph:

Resul
Maximum ts of
Permitt UV UV
UV-filter Other names concentrat safety
ed in A B
ion testin
g

4-
EU,
Methylbenzyli Enzacamene, MBC 4%*
AUS
dene camphor

Methylene Bis-
EU,
Benzotriazolyl
Bisoctrizole 10%* AUS,
Tetramethylbutylph
JP
enol, MBBT

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MALARIA
10%
Bis-
(EU, EU,
ethylhexyloxyphenol
Bemotrizinol AUS AUS
methoxyphenol triazine,
) 3% , JP
BEMT, anisotriazine
(JP)*

Tris-biphenyl EU,
10%
triazine AUS

Not generally
recognised as
safe and
Trolamine Triethanolamine effective accordin
12% AUS X
salicylate salicylate g to
the FDA.Remove
d from the market
in the USA.

Drometrizole EU,
15%
trisiloxane AUS

CAS 3121-60-6,
Sodium Dihydroxy
Benzophenone
Dimethoxy 10% JP
-9
Disulfobenzophenone [1
14]

Ethylhexyl 5% EU,
octyl triazone, EHT (EU, AUS
triazone
AUS
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SUNSCREEN PREPARATION

) 3%
(JP)*

Diethylamino
EU,
hydroxybenzo
10% JP,
yl hexyl
AUS
benzoate

10%
diethylhexyl butamido (EU) EU,
Iscotrizinol
triazone, DBT 5% JP
(JP)*

EU,
Polysilicone- Dimethico-
10% AUS
15 diethylbenzalmalonate
, JP

Isopentyl-4-
methoxycinnamate,
EU,
Amiloxate Isoamyl p- 10%*
AUS
Methoxycinnamate,
IMC

*
Time and Extent Application (TEA), Proposed Rule on FDA approval
originally expected 2009, now expected 2015.
Many of the ingredients awaiting approval by the FDA are relatively new, and
developed to absorb UVA.The 2014 Sunscreen Innovation Act was passed to
accelerate the FDA approval process.

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SUNSCREEN PREPARATION
FDA that do not allow ingredients in sunscreen prepration

Benzophenone is easily absorbed by the skin.

1. This chemical is present in most sunscreens. It tends to cause skin


initations and allergies.
2. Benzophenone- 3 behaves like the hormone oestrogen and increases the
mhers of oestrogen sensitive breast cancer cells. It also has the potential to
disrupt the hormonal balance of users

Other products that harm include

1. Homosalate and octyl-mclhoxycinnamate (also called octinoxate): this


also acts like oestrogen in test tubes.
2. Padimate-O is a derivative of PABA. PABA was earlier widespread in
sunsreen but caused irritations and was discontinued. Padimate-O is said
to cause damage to the DNA which could cause cancer.
3. Titanium dioxide application also indicates DNA damage. These last two
are as yet only lab and not human and living animal experiments.
4. Diethanolamine (DEA) and associated compounds like triethanolamine or
TEA may lead to cancer causing compounds if the sunscreen contains
nitrites.

The FDA agrees that this is possible e and is attempting to examine this. They
do not as yet acknowledge risk to users.

5. Parabens including butyl-, ethyl-, methyl-, and propyl-paraben are used


as in almost all sunscreens. They, like benzophenone act like and
therefore carry similar risk. Not using them means cutting out all
sunscreen use.
6. Symthetic fragrances could cause allergies or asthma.
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SUNSCREEN PREPARATION

Miscellaneous- according to harmful rays of sun that cantain Ultraviolet


Radiation.[25]

[7.4] MECHANISM OF ACTION OF SUNSCREEN PREPRATION

UV flters have been traditionally divided into chemical absorber and


physical
blockers based on their mechanism of action. Chemical sunscreens are
generally aromatic compound. conjugated with a carbonyl group. These
chemicals absorb high-intensity UV rays with excitation to a higher energy
state. The energy lost results in conversion of the remaining energy into
longer lower-energy wavelengths with returm to ground state. The evolution
of modern sunscreen chemicals represents a prototype study in the use
of'structure.

|7.5] ADVERSE EFFECT OF SUNSCREEN PREPRATION

In a longitudinal prospective study of 603 subjects applying daily either an


SPF 15 broad-spectrum sunscreen containing octal methoxycinnamate and
avobenzone or a vehicle cream, 19% developed an adverse reaction [14]
Interestingly, the rates of reaction to both the active and vehicle creamns
were similar, emphnasize importance of excipient ingredients in the vehicle.

The majority of reactions were irritant in nature. Not surprisingly, a


disproportionate 50% of the reacting subjects were atopic. Less than 10% of
the reactions were allergic, with none of the subjects patch tested actually
found to be allergic to an individual sunscreen ingredient.

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SUNSCREEN PREPARATION

Subjective iritation associated with burning or stinging without objective


erythema from some organic UV filters is the most frequent sensitivity
complaint associated with sunscreen use. This is most frequently experienced
in the eye area. Longer lasting objective irritant contact dermatitis may be
difficult to distinguish from true allergic contact dermatitis. In a postmarked
evaluation of sunscreen sensitivity complaints in 57 patients, 20 of the patients
had short-lasting svmptoms, 26 long-resting, and 1l mixed or borderline
symptoms half of the patients were patch and photo patch tested, and only three
showed positive reactions to sunscreen ingredients.[17]

Contact and photo contact sensitivity to individual sunscreen ingredients has


been extensively reviewed Considering their widespread use, the number of
documented allergic reactions is not high PABA and PABA esters accounted
for many of the early reported reactions, but with a decrease in their use
reactions to benzophenones may be increasing.

|7.6] Different types of Sunscreen Product

Commercialy available sunscreen products include -

-Sunscreen Lotions, Creams, Gels, Sprays and Powders: Sunscreen lotions are
best.

When exposure is prolonged. These products contain titanium dioxide.


Sunscreen creams are useful for less intense sun exposure. Sprays and gels are
also available. The latter can be worn under makeup.

-Sun Blocks.

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SUNSCREEN PREPARATION

-Eye and Lip Sunscreens

-Hand Sunscreens: hands show ageing and sun damage most easily. They are
amongst the most exposed parts of bodies.

-Antioxidant Sunscreens

-Makeup with Sunscreens: Some make up bases are very conveniently


available in
combination with a sunscreen.

-Tinted Sunscreen: These products are excellent for people who want to look
bronzed without harming their skins.

-Water Resistant Sunscreen: Water resistant sunscreen is reputed to protect the


skin for 40 minutes in the water and water proof ostensibly lasts 80 minutes.

-Sun Defense Kits: These kits package several products that can be used in
combination with each other together.

-Sunscreen for Babies and children

-Sunscreen Wipes

-Sunscreens for Sensitive Skin

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SUNSCREEN PREPARATION

CHAPTER-8

REGULATION AND
STANDARD

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REGULATIONS AND STANDARD Of SUNSCREENS:-

[8.1]United States
Sunscreen, products in the United States are regulated by the FDA as over-the-
counter drugs. The Final Monograph for Sunscreen Drug Products for Over-the
counter Human Use issued establishing the conditions. For safety recently
eficacy, and labeling of these products. The number of allowable sunscreen
ingredients has been reduced reflecting the lack of interest in some of the
ingredients in previously issued tentative monographs. Avobenzone and zinc
oxide have been added, expanding the available UVAI blocker.[23]
(8.2] Australian UV-A Standard
In Australia, UV-A protection is recognized when a sunscreen preparation
transmits between a wavelength of 320 nm and 360 nm (at a path length of 8
um) less than 10% of the incoming light. [Tinosorb] For people with extreme
photosensitivity, the Australian UVA standard is not very helpful in evaulating
sunscreens for how well they protect against UVA. This standard also leaves
the range from 360 to 400 nm completely unprotected
[8.3] USA No UVA Standard
That leaves FDA with an unresolved technical dilemma that it is trying to
resolve through additional research. "We are trying to determine a testing
method that will demonstrate that a sunscreen is providing UVA protection,
Lipnicki says. A claim Such as "broad spectrum" on a sunscreen label needs to
be supported by evidence has the product provides significant and meaningful
protection across the entire UVB/UVA spectrum. FDAl Matthew Holman,
interdisciplinary sciences team leader with the FDA, notes that the agency and
the manufacturers simply have lacked sufticient understanding of how UVA
works, how its effects can be measured and how products can be accurately

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SUNSCREEN PREPARATION
tested and labeled for their effectiveness against UVA. For now,
manufacturers are allowed to claim "broad spectrum" protection if their product
provides any amount of UVA protection.[23]

[8.4] Other Countries;


Most non-EEC European countries follow the EEC Directive. Many other
countries follow U.S. trends with their own provisions. In Japan, sunscreens
are classified as cosmetics. Regulations for each individual country need to be
consulted for selection of the various UV filters for incorporation into a
sunscreen product to be marketed in a given jurisdiction

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SUNSCREEN PREPARATION

CHAPTER-9

EVALUATION

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[9] EALUATION-

As in any other preparations, identification and quantitative determination of


various ingredients are essential for evaluation and quality control point of
view. Apart from these routine tests some special tests are also necessary for
these types of products.

[1] Spectrophotometric evaluation:

This is basically to evaluate the UV radiation absorption ability of the


sunscreen compounds,. Using a UV spectrophotometer and taking specific
concentration of the sub stance on the preparation, molar extinction coefficient
or absorbency can be determined and compared with any other standard
substance.

[2] Erythemal dosage :

It is important to estimate the erythemal effective radiation or E -vitons/cm2


transmitted by a suntan preparation The erythemal energy is the product of the
solar energy transmitted through the film of suntan preparation and the
effectiveness factor at that wavelength.

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SUNSCREEN PREPARATION

[3] Sunsereen index:

This is evaluation of the relative screening activity of the sunscreen


compounds. This is measurement of extinction coefficient at 308 mu
wavelength and comparison with other. 308 mu is the peak wavelength for
effective sunburn.

14] In-vivo skin testing:

This is a direct test on animal skin, particularly rabbit; the site normally used is
either backside or abdomen as these sites have maximum sensitivity.

Reparations are applied on a specific site and exposed to radiation along with
control unprotected site, for a specific period of time.

The effects are observed at the end of the period. Several factors or variables
are to be taken care of during the test as they may influence the results. Such
variables or factors are radiation source, size of the test field, etc.

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CHAPTER-10

CONCLUSION

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[10] CONCLUSION-

A limited menu of UV filters for incorporation into sunscreen


products is available to the formulating chemist, depending on
regulatory requirements in an individual country or jurisdiction. With
the demand for higher SPFs, the trend has been to use more
individual and a wider variety of agents in newer products.
Recent research in sunscreen efficacy has emphasized the need for
products protecting against the full UV spectrum with a limited
number of available agents. Regulatory agencies are very slow to
approve new ingredients.
Sunscreen efficacy remains very dependent on vehicle formulation.
Solvents and emollients can have a profound effect on the strength of
UV absorbance by the active ingredients and at which wavelengths
they absorb Film formers and emulsifiers determine the uniformity
and thickness of the film formed on the skin surface, which in turn
determines SPF level, durability, and water resistance. Lastly, product
aesthetics play a large role in product acceptance, particularly with
sunscreens being incorporated into daily-use cosmetics. These
constrains provide the sunscreen formulator with significant
challenges in developing new and improved formulations.

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References:-

1.Cosmetic books ender 0. Bore & Marc aye, “Hand book of cosmetic science
& Technology, Second Edition, Marten dicker, in Network Basel.
2.Mithal B.M & Saha R.N., A handbook of cosmetics, First edition 9000,
Vallabh Prakashan, Delhi, page No. 90-104.
3.Ross & Wilson, Anatomy and physiology in health & illness, tenth edition,
2000, churchill Livingstone, 358-360.
4.Tripathi K.D., Essential of medicine pharmacology, 4” edition, 1999, Jaypec
Brother, medical Publishers (P) Ltd, New Delhi, 2001, page No. 852.
5.Weinstocks MA Death from skin cancer among the elderly: Epidemiological
patterns Arch Dermatology 1997, 133:1207-1209.
6.Yaar M, Gilchrest BA, Aging versus photo aging postulated mechanisms and
effectors, J Invest Dermatology sump Proc 1998: 3: 47-51.
7.Naylor MF, Farmer KC, The case for sunscreen: a review of their use in
presenting actinic damage and neoclassic, Arch dermatology 1997:133:1146-
1154.
8.Gurish MF, Roberts LK, Krueger GG, et al. The effect of various sunscreen
agents on skin damage and the induction of tumor susceptibility in mice
subjected to ultraviolet irradiation Jives dermatology 1975, 65:543-546.
9.Thompson SC, Joly D, Marks R. Reduction of solar keratosis by regular
sunscreen use N Engle J Med 1993; 329: 1147-1151.
10.Boys as, Naylor M. Cameron GS, The effects of chronic sunscreen use on
the histological changes of dermatohalitosis. J Am Aced Dermatology; 1995;
33:941-946.

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SUNSCREEN PREPARATION

11.Roberts LK, Beasley DG Commercial Sunscreen lotion prevent ultraviolet-


radiation including. Immune suppression of contact hypersensitivity. J. Invest
Dermatology 1995; 105:339-344.
12.Stiller MJ, Bartolonew] J, Stern R, Smith S, Kollies N, Gillis R Drake LA.
Topical & to glibly acid and 8% L-lactic acid cram for the hearten of photo
damaged skin: a double blind vehicle compelled clinical fried. Arch
Dermatology 1996; 132-63-636.
13.Sheath NA Evolution of modern sunscreen chemicals. In Lowe NJ, Shaath
NA, Pataki MA.
14.Foley P, Nixon R, Marks R, et al. The frequency of reaction to sunscreens:
results of a longituodinal population-based study on the regular use of
sunscreen in Australia. Br J Dermatology 1993;128:512-518.
15.Levy SB. Sunscreen for photo protection. Dermatologic there 1997; 4:59-
71.
16.Fischer T, Bergstorm K. Evolution of customers complaints about sunscreen
cosmetics sold by the Swedish pharmaceutical Company.1991;25;319-322.
17.Dormgoolse SH, Maibach HI – Sunscreening agent intolerance contact and
photo contact sensitization and contact urticejria. J am aced Dermatology 1990;
22: 1068-1078.
18.Lenrique P, Machet L, Vaiilant L, teal. Contact and photocontact allergy to
oxybenzone. Contact Derma 1992; 26:177-181.
19.Fotiades J, Scoter NA, Lim HW. Results of evaluation of 203 patients from
photosensitivity in 97.3-year period. J Am Aced Dermatology 1995; 33 (4):
597-602.
20.Travis P, Vinanzic, chieregato C, et al. Sunscreen sensitization: a three year
study. Dermatol 1994; 189:55-57.

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SUNSCREEN PREPARATION

21.Agrapidis – Paloympis LE, Nash RA, Sheath NA. The effect of solvents on
the ultraviolet absorbance of sunscreen. J. Soc Cosmet Chem. 1987; 38:209-
221.
22. Dr. Lisa mangos, many key nc. For her assistance in obtaining sunscreen
from lotion information of cosmetic & Toiletries Magazine.
23.Regulation & standard, Available from, http://www.tog.gov.av/hpmeds/55
hen.
24.Background, Available from,http://www.freepatentsonline.com.
25. Active ingredient, Available from, www. Copperwiki. Org/y
indexiss.ingredient.
26.Active ingredient, Available from, www. Copperwiki. Org/
indexiss.ingredient.

BHUPAL NOBLES’ INSTITUTE OF PHARMACEUTICAL SCIENCES

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