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3494| International Journal of Pharmaceutical Research | Jan - Mar 2021 | Vol 13 | Issue 1
Review Article
A comparison of Natural and Synthetic Sunscreen
Agents: A Review
DEVANJALI BHATTACHARJEE , PREETHI S*, AMIT B PATIL ,VIKAS JAIN
Department of Pharmaceutics, Industrial Pharmacy JSS College of Pharmacy, Sri Shivarathreeswara
Nagara, Mysuru, JSS Academy of Higher Education and Research, Mysuru – 570015 Karnataka, India.
*Corresponding Author
Email:preethis@jssuni.edu.in
Received:10.08.20, Revised: 04.09.20, Accepted: 02.10.20
ABSTRACT:
Sunscreen Agents protect the skin from Ultraviolet (UV) rays by absorption, scattering and by blocking
phenomena. Ultraviolet (UV) rays are divided into three wavelengths UV-A,UV-B and UV-C in which UV-B
causes sunburn by affecting the epidermis layer. Active Ingredient of Sunscreen Agents is Synthetic Product
which is divided into Organic and Inorganic filters which is used in market. Organic filters have subtypes among
which Benzophenone and PABA derivative have some serious side effects, to overcome this deleterious effects
Natural Sunscreen came into existence. Natural products are efficacious as Sunscreen same as that of the
product which is present in the market. Different formulations of Synthetic and Natural Sunscreen are
discussed to know the efficacy of Sunscreen formulation. Market comparison of both the products are done
and their marketing products are mentioned. Regulatory guidelines of countries are discussed for the safety
and efficacy of Sunscreen product available in the market and Testing procedures is also mentioned. Sunscreen
patents are discussed to know about innovations done in cosmetic field even clinical trials of different
formulations is done to know the safety and efficacy of the product before launching into the market.
Keywords: Skin, Sunscreen, Organic filters, Natural Products, Inorganic filters.
INTRODUCTION:
Sunscreens are those agents which absorbs,
scatter or block UV radiation. [1] It controls the
deleterious effects like premature aging which can
lead to sagging, wrinkling, hyperplasia associated
with UV radiation. [2] The active ingredients used
in Sunscreen preparation are divided into
Organic and Inorganic filters based on the
mechanism of action and chemical
composition.[3]Organic filters absorb the UV
radiation while Inorganic filters protect skin by
scattering and reflecting UV radiation.[4]This
agents are found as over-the-counter products in
supermarkets and pharmacies, even it is sold by
physicians in USA directly, in Italy by hospitals
and in Australia by Cancer charities and Cancer
control Organisation.[5]
The largest organ of the body is skin which covers
15% of the total body mass of an adult.[6]
Integument is an outer covering of skin which is
derived from the Latin word integere. [7]The skin
not only varies from one individual to other but it
varies because of the geographical location and
with respect to colour, texture, thickness of the
skin layers and adrenal structures like sweat
glands, sebaceous glands, hair follicles.[8]Skin
structure consists of mainly three layers: (a)
Epidermis, (b) Dermis, (c) Hypodermis and their
functions are different from one another It mainly
protects from pathogens, UV light, chemicals and
injury because of its structure made up of intricate
network which acts as a barrier. It also regulates
the temperature and amount of water released
into the external environment.[9]
Sunlight is an electromagnetic radiation of
continuous spectrum which is divided into three
main spectrum of wavelength: (a) Ultraviolet, (b)
Visible, (c) Infrared.[10]Ultraviolet (UV) radiation
is further divided into three ranges: (a) UV-A
(320-400 nm), (b) UV-B (280-320 nm), (c) UV-C
(200-280 nm) among which UV-A has highest
wavelength and less energy, UV-C has high
energy and shorter wavelength while UV-B
remains in the mid-range. [11]Around 80-90% of
UV-A and 1-10% of UV-B reach the earth’s
surface while UV-C gets absorbed to earth’s
atmosphere .[12]UV-A can penetrate to deeper
layer of dermis and it can damage DNA by
indirect photosensitizing reaction by production of
reactive oxygen species. UV-B is reaches to
epidermis layer and it is absorbed by DNA which
results in molecular rearrangements forming
photoproducts like cyclobutene dimers and
pyrimidine (6-4) pyrimidine (6-4 photoproducts)
as shown in Figure 1 and UV-C gets absorbed to
ozone layer of earth’s stratosphere .[13] [14]UV
ISSN 0975-2366
DOI:https://doi.org/10.31838/ijpr/2021.13.01.524
Devanjali Bhattacharjee et al/ A comparison of Natural and Synthetic Sunscreen Agents: A Review
3495| International Journal of Pharmaceutical Research | Jan - Mar 2021 | Vol 13 | Issue 1
exposure is a main reason for age related
changes such as development of skin cancer
because of skin’s anatomic location at external
part of body. [15]To overcome this problem
Sunscreen Agents are used.
Fig.1:Anatomy of skin layers and showing penetration of UVA and UVB radiation into skin layers
Ideal properties of Sunscreen products:
Sunscreen should absorb a broad range of
UV spectrum for protecting the skin from UV
rays.
There should be no chemical breakdown
which will result into decrease in efficacy or
increased toxicity or irritation because of by-
products.
It should have suitable properties while
formulating with cosmetic base and it should
penetrate the skin easily.
It should not get removed by water or
perspiration.
For effective results, frequent re-application of
sunscreens should not be required.
At low concentration, it should be effective.
It should not cause irritation, sensitization and
toxicity to the skin.[16]
Classification of Sunscreen:
Classification of sunscreen agents is based on the
composition and mechanism of action is shown in
Figure 2 . Sunscreen agents works by different
method by blocking, reflecting and scattering the
UV radiation.[17]
Fig.2:Classification of Sunscreen
Devanjali Bhattacharjee et al/ A comparison of Natural and Synthetic Sunscreen Agents: A Review
3496| International Journal of Pharmaceutical Research | Jan - Mar 2021 | Vol 13 | Issue 1
Synthetic Sunscreen:
Synthetic Sunscreen contains Organic and
Inorganic filters. Chemical sunscreen are physical
blockers which reflect or scatter UV rays and it
also absorbs high energy UV rays. Organic
compounds protects against a range of UV ray
spectrum which is included with chemical
sunscreen. By spreading the microparticles of
inorganic compound on epidermis which is upper
layer of skin increases the optical path of photons
which results in absorption of photons in high
amount by increasing the Sun Protection Factor
(SPF) ultimately increases the efficacy of
compound.[17] [18][19]
Organic filters:
Organic filters are those ingredients which will
absorb specific wavelength of UV radiation
depending on their chemical structure. The filter
which is in low energy level converts to high
energy level.(16) From this high-energy level, one
of the following three processes can occur
depending on the filter's ability to process the
energy it has absorbed:
i. Photostable filter: This filter form
dissipates the absorbed energy as heat
energy to the atmosphere and returns to
the low-energy level (ground state). It is
efficient at reabsorbing UV energy.
ii. Photo-unstable filter: Upon absorption of
UV energy, a change in its chemical
structure or degradation occurs. It cannot
consume UV energy again.
iii. Photoreactive filter: The filter interacts
with neighbouring molecules in its excited
state, including other ingredients of
proteins and lipids from sunscreen,
oxygen, and hair. This leads to reactive
species being generated that may have
undesirable biological effects.[20]
Types of Organic filters:
Dibenzoylmethane Derivatives: This derivatives
contains high absorption capacity in UV-A region
but as it decomposes in presence of sunlight
irradiation which will decrease the efficiency of
sun protection at the time of UV exposure.
Photofragmentation of this derivatives occur which
will lead to formation of free radicals which will
cause skin damage.[21]
Benzophenone Derivatives: This derivative
absorb or dissipate Ultraviolet radiation mainly
UV-A. Matsumoto et al., 2003 reported cytotoxic
effects in this derivatives. [22]
Para-Aminobenzoic acid (PABA) and its
derivatives: This derivative absorbs UV-B
radiation. It is soluble in 70% alcohol at
concentration of 2-5%, as it penetrates into the
deeper layer of dermis due to which it retain for
longer time in skin. [23] Photoallergic reactions
occur due to PABA. [24]
Salicylate Derivatives: This derivatives weak
absorbers of UV-B radiation. They are used to
minimize the photodegradation of other
photoprotectants. [25]
Benzotriazoles: Mexoryl SX is a photostable
broad spectrum filter having effective sun
protection ability. It decreases the events of
photoaging, photosensitivity reaction and Mexoryl
SX is a trademark of L’Oreal. [26]
Inorganic filters:
Inorganic filter scatter and reflect back UV rays to
the external environment. It acts as a physical
barrier for UV radiation. This filters are
considered to be broad spectrum as it covers the
entire UV range. Common inorganic filter are
Titanium dioxide and Zinc oxide. [27]
Different formulations of Synthetic material:
Nanotechnology based formulation are better
than Pharmaceutical formulation as it is elegant
and effective. Nano-capsules based cosmetic
product was launched by L’Oreal for getting
effective results of the cosmetics and for the
growth in market.[28] Solid lipid nanoparticles
are used because it has controlled release
property, enhanced skin permeation and toxicity
level is less. Nano lipid carrier is having high
loading capacity and having long term stability.
[29]
Nano Lipid Carrier (NLC)
In Nano lipid carrier the drug is incorporated into
the mixture which have ratio of solid lipids and
liquid lipids and it is designed in such a way that
it does not form crystals which is a drawback in
Solid Lipid Nanoparticles. [30]Rania et al
prepared the oxybenzone loaded NLC which was
formulated as gel and reported increase in six to
eight times in vitro SPF and erythemal UVA
protection than the free oxybenzone formulation.
It has low potential side effect of skin irritation.
[31]
Nano-capsules
Nano-capsules are nanoparticles which are
hollow spheres with diameter of less than 200
nm. It can be filled with either polar or non-polar
solvent.[32] Alvarez et al prepared nano-capsules
of Octyl methoxycinnamate with biodegradable
polymer and reported that Octyl
methoxycinnamate loaded nano-capsules provide
protection against UVA induced erythema better
than a conventional gel.[33]
Nanoparticles
Nanoparticles are those particles whose size
range is 1-100 nm and it is one-dimension
Devanjali Bhattacharjee et al/ A comparison of Natural and Synthetic Sunscreen Agents: A Review
3497| International Journal of Pharmaceutical Research | Jan - Mar 2021 | Vol 13 | Issue 1
structure .[34] Marcela et al prepared a new
sunscreen formulation by encapsulating zinc
oxide nanoparticles and octocrylene in poly-
styrene-co-methyl methacrylate (PMMA/PS)
nanoparticles via mini-emulsion polymerization,
PMMA nanoparticles were incorporated in the gel
. He reported that gel containing PMMA
nanoparticles was having Sun Protection Factor
(SPF) greater than 30. [35]
Nanosuspension
Nanosuspension is a sub-micron colloidal
dispersion having particle size below1µm and
which is stabilised by surfactant .[36] Villalobos et
al prepared nanosuspension of carnauba wax
and titanium dioxide which is distributed to
aqueous phase and lipid phase. He reported that
SPF value of titanium dioxide nanosuspension
distributed in liquid phase is higher than that of
aqueous phase. [37]
Problems encountered with usage of Synthetic
material:
As Organic filters absorbs UV radiation due
to which photodegradation and generation of
free radicals occur which will lead to skin
damage.
Para Amino benzoic acid shows photoallergic
reactions and photosensitivity reactions on
skin.
Serpone et al reported that Inorganic filters,
photoactivation of metal oxides by UV
radiation can lead to generation of reactive
oxygen species which can be cytotoxic and
genotoxic.
Lai et al reported that exposure of Titanium
dioxide micro or nanoparticles can cause cell
death in human neural cells and fibroblasts.
Deng et al; Nohynek et al reported that zinc
oxide nanoparticles can cause neural stem
cell apoptosis but the toxic effect is related to
chemistry of the structure rather than particle
size of the preparation.[38]
Pan et al reported that Titanium dioxide
nanoparticles having particle size of
(15±3.5nm) pass through the cell membrane
and damages the function of dermal
fibroblast culture.[39]
Natural Products as Sunscreen: Table 1: List of Natural Sunscreen Products
Natural products are produced by living
organisms as a secondary metabolite which is
found in nature. Living organisms which are
exposed to UV radiation have a numerous photo-
adaptive mechanisms which will include
antioxidant and UV-absorbing property.[40]
Sources of Natural Sunscreen products:
List of Natural products which are used in
preparation of Sunscreen formulation and are
listed in Table 1:
Natural Sunscreen, Biological Source
Geographical Source
Part of plant
Aloe Vera, Aloe barbadensis (41)
East and South Africa (42)
Leaves (43)
Rambutan, Nephelium lappaceum (44)
Southeast Asia like Malaysia,
Indonesia, Thailand (45)
Peel of fruit (46)
Propolis, Apis mellifera (47)
Europe, North America, non-
topical regions of
Asia (48)
Resins obtained from different
parts of plants (49)
Black Tea, Camelia sinensis (50)
Asia, Africa, South America
(51)
Leaves (52)
Curcumin, Curcuma longa (53)
India, China, Pakistan, East
Indies (54)
Rhizomes (55)
Pomegranate, Punica granatum (56)
Mediterranean basin, America,
Australia, South Africa, Asia
(57)
Fruits, peel(58)
Grape, Vitis vinifera (59)
South America (60)
Seeds (61)
Tomato, Solanum lycopersicum (62)
Central Asia, Mediterranean
Basin(63)
Fruit (64)
Ginkgo, Ginkgo biloba (65)
China, Japan (66)
Leaves (67)
Avocado, Persea americana(68)
Mexico, South Africa, Brazil
(69)
Seeds (70)
Devanjali Bhattacharjee et al/ A comparison of Natural and Synthetic Sunscreen Agents: A Review
3498| International Journal of Pharmaceutical Research | Jan - Mar 2021 | Vol 13 | Issue 1
Different formulations of Natural Sunscreen
products:
Nano-formulations are used because of its high
entrapment efficiency and increased skin
permeability. Curcumin have high stability and
solubility after preparing liposomes which
ultimately increases bioavailability. Phytosomes of
Liquorice has increased the skin permeation and
retention time. Solid lipid Nanoparticles of
Luteolin give slow release kinetics rather than
spillage of whole drug from the transdermal
patch.[41]
Solid Lipid Nanoparticles (SLN) :
Solid Lipid Nanoparticles comprises of lipid which
is dispersed in water or in aqueous surfactant
solution. It is a sub-micron colloidal carrier in the
size range of 50-100 nm [42]. Solid Lipid
nanoparticle of Aloe vera was prepared by micro-
emulsification technique. Lavita et al reported that
the in vitro SPF of Aloe vera
loaded SLN was found to be 16.9± 2.44 and in
vivo SPF was found to be 14.81±3.81
respectively. SLN loaded with Aloe vera was
incorporated into a cream and SPF of resultant
sunscreen cream is equal to the SPF of Sunscreen
product available in market [43].
Nano-emulsion:
Nano-emulsion are submicron emulsion in nano
size range. [44]It comprises of two immiscible
liquids like water and oil which is stabilized by
surfactant and co-surfactant, reducing the
interfacial tension. This are isotropic dispersion
which is thermodynamically and kinetically stable.
[45]Nano-emulsion of Rambutan was prepared
which is incorporated in gel. Muhtadi et al
reported that SPF of Rambutan nano-emulsion
gel was found to be 13.120±0.001.[46]
Phytosomes:
Phytosome word is derived from “Phyto” means
“plant” and “some” means “cell like”.[47] In this
plant extract is loaded into phospholipid to make
lipid compatible molecular complexes. It is
patented by the nutraceuticals and leading
manufacturer of drug. Andi et al reported that
hydrogel containing Propolis phytosome had an
ability to absorb UV-A and UV-B, SPF value was
found to be higher than 15. [48]
Niosomes:
Niosomes is a bilayer vesicular structure of non-
ionic surfactant which will enclose the aqueous
solution of solutes and lipophilic component in
the bilayer. The bilayer structure can be
unilamellar or multilamellar. [49]Meng et al
reported that major compounds of Black Tea
Extract (BTE) were caffeine and gallic acid.
Niosomes of BTE was prepared which is
administered through transdermal delivery system
and transdermal absorption rate of caffeine and
gallic acid was high.[50]
Liposomes:
Liposomes are small vesicular structure composed
of cholesterol and natural non-toxic
phospholipids. The size range is 0.025µm to
2.5µm.[51]Haiyang et al reported that the skin
permeation of Quercetin liposomes was 3.8 times
higher than Quercetin suspension. It shows cell
viability of UV-B irradiated HaCat cells increased
to 89.89±4.5% for 24 hours and 78.8±3.19%
for 48 hours.[52]
Merits of Natural Sunscreen over Synthetic
Sunscreen:
Natural Sunscreen are used instead of
Synthetic Sunscreen like oxybenzone and
octinoxate in Hawaii, Key West and US Virgin
Islands because Synthetic Sunscreen causes
bleaching of coral reefs. [53]
Synthetic sunscreen affects the human skin by
inducing Reactive Oxygen Species, natural
antioxidants like alpha carotene, ascorbic
acid, flavones have capability of donating
electrons and cease free radical chain
reaction.[54]
Natural Sunscreen protects the skin from
early maturing and it keeps the skin smooth
and energetic. [55]
Natural sunscreen are cheaper than Synthetic
Sunscreen and they are easily available. [56]
They are compatible with all skin types. [56]
Market of Synthetic and Natural Sunscreen:
Global Sunscreen cream market will be around
USD 8279.9 million by 2026 from USD 6098
million in 2020 at a Compound Annual Growth
Rate of 5.2% during 2021-2026. Europe, North
America and China are top countries which have
consumption share of 24.9%, 22.6% and 20.4%
in 2019. Estee Lauder, L’Oreal, Johnson and
Johnson, Shiseido are the companies which is
dominating the Sunscreen market.[57]Sunscreen
protection market in India have recorded CAGR
of 12.01% in time duration of 2013-2018 with a
sales of INR 4945.23 million in 2018, an
increase of 10.25% over 2017. [58]Market of
Global Herbal Skincare from 2019-2024 was
around USD 2.31 billion by the end of 2024 and
growth rate was 5.6%.[59] According to Indian
sunscreen Market sheet, Over-the-counter
Sunscreen market was around INR 245 crore and
Prescription Sunscreen market was around INR
138 crore. As part of total Sunscreen market,
Over-the-counter sunscreen market was
dominating the overall Sunscreen market by 75%
.[60]Marketed product of Natural and Synthetic
Sunscreen is listed in Table 2.
Devanjali Bhattacharjee et al/ A comparison of Natural and Synthetic Sunscreen Agents: A Review
3499| International Journal of Pharmaceutical Research | Jan - Mar 2021 | Vol 13 | Issue 1
Table 2: Marketed Products of Synthetic and Natural Sunscreen
Marketed Product
Active Pharmaceutical
Ingredient (API)
Formulation
Benefits
Name of
Company
Synthetic Sunscreen
Rosy Tone Broad
Spectrum SPF 30
Sunscreen (48 g)
Avobenzone-3%
Homosalate-2.7%
Octisalate-5%
Octocrylene-7%
Cream
Anti- aging
Keeps skin hydrated
L’Oreal Paris ()
Protect and
Moisture Sun
Lotion-SPF 50 (125
ml)
Octocrylene
Butyl
Methoxydibenzoylmeth
ane
Lotion
Protection against
UV-A and UV-B.
Sun and Collagen
Protection.
Moisturising.
Nivea ()
Sheer Zinc Face
Dry- Touch
Sunscreen Broad
Spectrum SPF 50
(59 ml)
Zinc oxide (21.6%)
Lotion
Protect against UV-
A and UV-B rays.
Water resistant.
Non- Comedogenic
Neutrogena ()
Sunforgettable total
Protection Brush-On
Shield SPF 50
Zinc oxide (22.5%)
Titanium Dioxide
(22.5%)
Brush-on
Water resistant.
Provide protection
against UV-A and
UV-B rays.
Colorescience
()
Natural Sunscreen
Age Prevention SPF
45 Anti-aging
Moisturizing
Sunscreen (50 ml)
Sacred Lotus
Cream
Protect against UV-
A and UV-B rays.
Waterproof and
Sweatproof.
Replaces lost
moisture.
Maintain skin tone.
Mitchell USA ()
Mamaearth
Hydragel Indian
Sunscreen (50 g)
Aloe Vera
Raspberry
Glycerine
Hydragel
Protect against UV-
A and UV-B rays.
Provides hydration.
Gives natural glow
to skin.
Suitable for all skin
types.
Honasa
Consumer Pvt
Ltd ()
Bio Sandalwood
Sunscreen Lotion
(120 ml)
Sandalwood
Ashwagandha
Arjun
Honey
Lotion
Protect against UV rays.
Retains moisture in skin.
Biotique
Advanced
Ayurveda ()
SPF 40+ Sunscreen
Spray Lotion
PA+++ UVA/UVB
Protection (120 ml)
Jojoba oil
Argan oil
Shea butter
Spray lotion
Protect skin from UV-A and
UV-B rays.
Intense Moisturisation and
Hydration.
Reduces Sun burn and Tan.
Reduces Wrinkles and Fine
lines.
Greenberry
Organics ()
Patents of Synthetic and Natural Sunscreen:
There is a brief information on Sunscreen patents
including patent application number, date of
filing, name of patentee and patent inference. List
of Patents are given in Table 3.
Devanjali Bhattacharjee et al/ A comparison of Natural and Synthetic Sunscreen Agents: A Review
3500| International Journal of Pharmaceutical Research | Jan - Mar 2021 | Vol 13 | Issue 1
Table 3: Patent list of Synthetic and Natural Sunscreen
Date of Filing and
Application Number
Name of Patent
Patentee
Inference
I. Synthetic Sunscreen
Oct 27, 2020
US 10,813,875 B2
Memory shape
sunscreen
composition
Faig et al
Memory-shape skin-care
composition includes
avobenzone, octocrylene
and homosalate. It
contains memory-shape
material which includes
a polyethylene
glycol/hexamethylene
diisocyanate co-polymer.
(99)
Sep 10, 2020
US 2020/0281827
A1
Microcapsules
comprising
sunscreen agents
Goldstein et
al
Microcapsules contains
one or more sunscreen
agents and the shell of
microcapsules is non-
rupturable. (100)
Nov 1, 2018
US 2018 / 0311122
A1
Sprayable
sunscreen
composition with oil
beads
Lu et al
At least Hydrophobic
and Hydrophilic UV-
screening agents are
used. (101)
Natural Sunscreen
Mar 19,2020
US 2020/0085724
A1
Sunscreen
Compositions With
Natural Waxes For
Improved Water
Resistance
Hwang et al
In this sunscreen
formulation is water
resistance by the use of
Natural waxes. (102)
June 16, 2015
US 9,056,063 B2
Natural sunscreen
composition
Hanson et al
Natural extracts, oils are
used as sunscreen
enhancers for Synthetic
Sunscreen. It also protect
form harmful effects of
UV rays. (102)
Feb 10, 1998
US5716602A
Insect repellent
sunscreen
Uick et al
Sunscreen formulation
which include water
resistance agent and an
insect repellent. (103)
Regulatory aspects of Sunscreen:
Regulatory guidelines are present to maintain the
safety and toxicity of the Sunscreen formulation.
Different countries have different guidelines for
Sunscreen but the ultimate goal is to protect the
skin from harmful UV rays.
United States Food and Drug Administration
(USFDA) guidelines:
USFDA proposed new regulations for
ensuring the safety and efficacy of Sunscreen
formulation in 2019. It suggested that out of
16 ingredients which are currently in the
market, among them two ingredients- Zinc
oxide and Titanium dioxide are safe and
effective to use in Sunscreen while PABA and
trolamine salicylate are not to be used in
Sunscreen because of safety issues. Due to
lack of safety data, 12 ingredients are not
getting approval from FDA to be used in
Sunscreen and FDA is seeking more data to
evaluate safety and efficacy.
Creams, gels, lotions, ointments, oils, sprays
are safe and effective as a sunscreen while
powders are eligible to be included in
monograph but more data is required for
inclusion in monograph.
Sunscreen with SPF value 15 or more than 15
should provide broad spectrum protection
Devanjali Bhattacharjee et al/ A comparison of Natural and Synthetic Sunscreen Agents: A Review
3501| International Journal of Pharmaceutical Research | Jan - Mar 2021 | Vol 13 | Issue 1
and increase in SPF will provide protection
against UVA.
New Sunscreen product labelling requires
addition of active ingredients in front of
package and an alert should be there for
“Skin cancer/ Skin aging” for Sunscreen
having SPF less than 15.
Sunscreen products in combination with insect
repellent are not safe and effective.[61]
European guidelines:
Manufacturers voluntarily comply with a
recommendation that all sunscreen product
should give protection against UVA at least one-
third as strong as SPF. SPF is the measure of
products ability to give protection against UVB
which will burn the skin (European Commission
2006, COLIPA 2009). [62]
Indian guidelines:
Indian Drug and Cosmetic Act (1940) amended
that sunscreen should be considered as a
cosmetic. Bureau of Indian Standards (BIS) which
is a member of ISO (International Organization
for Standardization) set standards for relevant
cosmetic products. Stability data is mandatory
and there is no SPF rating for Sunscreens. [63]
ASEAN guidelines: [64]
The testing procedures for Sunscreen are given by
ISO to ASEAN member countries which will export
their products in other countries. List of testing
procedures are given in Table 4.
Table 4: Testing Procedure according to ASEAN guidelines
Testing Procedures
Countries
SPF test – in vivo
China, Korea, Australia, USA, New Zealand,
Canada and Europe.
UVA – PPD Testing
Japan
UVAPF in vitro testing
Australia, New Zealand
Clinical trials:
Clinical trials are done to assess the safety and
efficacy of the sunscreen product. According to
Food and Drug Administration (FDA), clinical
trials are done in healthy adult humans.[65]
Clinical trials done on Sunscreen products listed
in Table 5.
Table 5: Clinical trials of Synthetic and Natural Sunscreen
REGISTRATION NUMBER
TRIAL
STUDY PROTOCOL
PHASE TRIAL
COUNTRY
CTRI/2012/08/002910
Interventional
Effect of Neutrogena ®
sunscreen with pigments that
absorb visible light in
combination with night
regimen in reduction of facial
hyper pigmentation
NA
India(109)
CTRI/2013/07/003813
Interventional
Evaluate safety of La shield
Lite Sunscreen Gel SPF 40
NA
India(109)
CTRI/2018/02/011922
Interventional
Testing of Sunscreen creams
NA
India(109)
CTRI/2020/09/027895
Interventional
Assessment of Varnya Lepa
Sunscreen lotion
Phase 1/ Phase 2
India(109)
NCT01021787
Intervention
To determine penetration of
Titanium dioxide via human
skin
Phase 4
Canada (110)
NCT02857478
Intervention
To assess the safety of
sunscreen product for sport
users
NA
USA(111)
NCT00549588
Intervention
Efficacy of Sunscreen SPF 30
and after sun lotion in
prevention of Polymorphic
Light Eruption
NA
Austria(112)
NCT00711256
Intervention
To study persistence of Sun
Protection Factor and
influence of Vitamin D on
Sunscreen
NA
Denmark(113)
Devanjali Bhattacharjee et al/ A comparison of Natural and Synthetic Sunscreen Agents: A Review
3502| International Journal of Pharmaceutical Research | Jan - Mar 2021 | Vol 13 | Issue 1
Future Perspective:
Sunscreen is used to protect the skin from the
detrimental effect of UV rays. There are new
technologies for the preparation of sunscreen in
upcoming years. The future of Sun Protection is
getting smarter as new developments involves UV
skin patch which will detect UV exposure on skin
as the patch contains photosensitive blue dye
which changes colour when exposed to UV rays.
[66]Zebrafish and other animals produce a
material called gadusol which protect them from
UV rays by expressing the right genes in yeast
there is a way to create of ingestible sunscreen.
[67]DNA films are to be created by the
researchers as UV rays damage the DNA, the
ultimate goal is to protect body’s DNA by giving
topical layer of DNA to
damage.[68]Cyanobacteria was found to be an
safer alternative for synthetic product used in Sun
Protection currently. [69]
CONCLUSION:
From this we can conclude that Sunscreen made
up of natural products are better than the
formulation made up of Synthetic products. The
exposure of Ultraviolet rays damages the skin
function in which UV-B affects the upper layer of
skin causing Sunburn, to treat this skin disease
Sunscreen agents are used. Synthetic Products
present in formulations are effective but they are
having side effects like endometriosis, cytotoxicity,
genotoxicity. To overcome this problem Natural
Products are used as a Sunscreen which has
minimal side effects and it is efficacious as
Synthetic Product.
Conflict of Interest:
The Author have no conflict of interest to declare.
Acknowledgement
Authors are thankful to JSS Academy of Higher
Education and Research, Department of
Pharmaceutics, Industrial Pharmacy, Jss College
of Pharmacy, Mysuru-570015, Karnataka, India.
Source of Funding:
NIL
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