personal care | sun care
content
A Balanced Approach for Formulating Sunscreen Products Using Zinc Oxide
E. Bartholomey, S. House, F. Ortiz*
abstract
Z
inc oxide is a sunscreen ingredient for products that require formulations to have broad spectrum protection. Various particle
sizes and coatings are available allowing flexibility in creating a sunscreen with a high SPF, PFA, and critical wavelength. Particle size can be varied to achieve optimal results and a wider range of product forms can be created. Surface treatments can
help to improve the dispersibility and stability of zinc oxide in oils, esters, and aqueous systems.
Introduction
Zinc oxide (C.I. Pigment White 4 – 77947) and titanium dioxide (Pigment White 6 – 77891) are the two primary white
pigments used in the cosmetic and pharmaceutical industries.
Both have good hiding power and are very useful for their
absorbance and scattering of ultraviolet radiation. Sunscreens
designed for children or people with sensitive skin are often
based on titanium dioxide (TiO2) and/or (ZnO).
The FDA recognizes zinc oxide for use in calamine lotions as
an OTC skin protectant. Calamine powder USP is chiefly zinc
oxide acting as the essential ingredient with 0.5 % iron oxide.
Calamine contains not less than 98.0 % ZnO. It is approved
by the Food and Drug Administration as a Category I skin
protectant, meaning that it is safe for compromised or environmentally challenged skin. [1]
Owing to its mild antiseptic properties, zinc oxide is used in
preventing the growth of fungi and bacteria in paints. Its
pharmaceutical use in zinc ointment has long been known.
There is also new research regarding its antibacterial properties to reduce infections. [2]
the “American process” produces the product directly made
from the ore. Both are vaporization type processes using furnaces. To obtain products of high purity, removal of heavy
metals, such as cadmium and lead, can be accomplished by
fractional distillation at temperatures exceeding 1000 °C. USP
grades of zinc oxide are generally made by this purer process.
In the liquid phase process, zinc oxalate, zinc hydroxide or
basic zinc carbonate is synthesized, precipitated, separated by
filtration with rinse and then thermally decomposed to obtain
zinc oxide.
Nanoparticles of zinc oxide with a hexagonal wurtzite crystal
structure can be produced by means of chemical vapor deposition, spray pyrolysis, thermal evaporation, and wet-chemical
route etc. The wet chemical route has become a best practice method for engineered ZnO nanoparticles because of the
mild reaction conditions and simplicity of the synthesis process. Zinc acetate and zinc nitrate are used as starting materi-
Manufacturing of Zinc Oxide
In nature, zinc oxide occurs as the rare mineral, zincite, which
usually contains manganese and other impurities that confer a
yellow to red color to the structure. Zinc ores such as sphalerite
(wurzite), franklinite, and willemite are also used in addition to
zincite to produce the homogenous form of zinc oxide.
Known production processes for these zinc oxide powders
are roughly classified into a liquid phase process and a gas
phase process.
The gas phase process includes a French process of oxidizing
zinc vapor and an American process of oxidizing zinc vapor
generated at the smelting process of zinc ore.
The “French process” for zinc oxide indicates that the pigment
is made directly from the metal with higher purity, whereas
18
Fig. 1Zinc oxide – Primary particle size (PPS) at 20 nm (left – nodular)
and (right – acicular) 60 nm
sofwjournal | 142 | 03/16
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personal care | sun care
als. [3] There are a number of patents for various techniques
and processes to produce ultrafine zinc oxides, especially
novel variations on the French vaporization method.
Stability
Zinc oxide is stable towards light and does not discolor. The pH
value of zinc oxide is 7.1–7.5. Because of its slightly basic character, the oxide tends to form soaps with fatty and resin acids when
available. ZnO reacts slowly with fatty acids in oils to produce the
corresponding carboxylates, such as oleate and stearate. The reactivity of zinc oxide with vehicles is affected considerably by the
particle size, being most rapid in the colloidal or finely dispersed
grades. The use of proper surface treatments for zinc oxide can
help to minimize this reaction, if needed.
Zinc oxide is an amphoteric oxide. Though insoluble in water,
it dissolves readily in mineral acids and even weak acids.
ZnO + 2 HCl → ZnCl2 + H2O
Weaker acids, such as acetic, will attack the pigment more
slowly than mineral acids. As mentioned above, it will also
react slowly with fatty acids in oils and fats.
Zinc oxide will also dissolve in alkalis, such as ammonia or
ammonium carbonate. The solubility in dilute ammonium hydroxide is due to the formation of the complex ion of zinc and
ammonia. It will form other zincates with other bases, such as
sodium hydroxide.
ZnO + 2 NaOH + H2O → Na2[Zn(OH)4]
Therefore, it is a good strategy to test various methods of addition for zinc oxide in formulations, if carboxylic or mineral
acids, fatty acids or alkali are needed in the formulation.
Do not use zinc oxide with aluminum or magnesium powders. Upon heating they may react with possible ignition.
Aluminum powders are sometimes used in eye cosmetic
products.
Surface treatments, such as triethoxycaprylylsilane or dimethicone, for zinc oxide will enhance its dispersibility in various
carriers, such as natural oils, esters, and silicone fluids.
Chemical and Physical Properties
Zinc oxide absorbs infrared radiation below 1000 nm. The
hiding power diminishes as the particle size decreases
from about 250 nm in diameter. The significantly lower
refractive index of zinc oxide when compared to titanium
dioxide also provides a higher degree of transparency. The
medium in which the pigment is dispersed helps to determine the final opacity of the pigment and can increase
transparency.
20
Another advantage of zinc oxide over titanium dioxide is that
it is a softer material. Mohs scale was developed to compare
the hardness values of different materials on a macro scale.
It ranges between the values from 10 (highest assigned to
diamond) and 0 (lowest assigned to talc). The general rule
is materials with lower Mohs scale value are susceptible to
scratches when they get rubbed by higher Mohs scale value
materials. As shown in Tab. 1, ZnO, is a softer substance compared to many other cosmetic materials.
Sunscreens
Zinc oxide powders having different particle sizes, or size distributions can be chosen to selectively attenuate UV rays. This is accomplished through absorption, scattering or a combination of
the two for the UVA and UVB wavebands respectively. Larger and
smaller particles selectively absorb and scatter UVB and UVA.
UVB rays penetrate the epidermis, but UVA rays go deeper into
the skin to the dermis. Zinc oxide has been used as a broad
spectrum sunscreen. Like titanium dioxide, it effectively provides
comprehensive protection against UVB and both ranges of UVA,
short and long. It uniformly covers from 290 to 380 nm, thus
protecting against UVB and most of the UVA spectrum. No other
sunscreen ingredient provides broader absorption.
Zinc oxide absorbs more broadly than its counterpart, titanium dioxide, as it extends into the 340–400 nm area whereas
titanium dioxide is muted just above 350 nm.
A sunscreen with an SPF 15 filters about 93 % of UV-B rays;
SPF 30 filters about 97 % of UV-B rays; and SPF 50 filters
about 98 % of UV-B rays. The difference between SPF 30 and
SPF 50 is only a 1 % filtering improvement. It is feasible to formulate with zinc oxide alone or in combination with titanium
dioxide and forego the use of synthetic sunscreen agents to
achieve an SPF 30 which filters 97 % of the UVB radiation.
The use of sunscreen boosters, such as antioxidants, have
been known to supplement the inorganic sunscreens when
Value
1 (Softest)
Material
Talc
2
Hexagonal boron nitride,
Mica (2.0–2.5)
Calcite (calcium carbonate), Barium sulfate
3
4
5
6
7
8
9
10 (Hardest)
Zinc oxide (4.5),
Hydrated silica dioxide (2.5–5.0)
Iron oxide Fe3O4 (5.5),
Titanium dioxide (5.5) (Anatase)
Titanium dioxide (6.5) (Rutile)
Tin oxide
Zirconium oxide
Alumina (9.25)
Diamond
Tab. 1Mohs scale of hardness for minerals
sofwjournal | 142 | 03/16
content
Brazil
US
TiO2
< 25 %
< 25 %
EU
< 25 %
Japan
China
Canada
Australia
no limit
< 25 %
< 25 %
< 25 %
ZnO
<25 %
<25 %
<25 %
approval pending
no limit
<25 %
<25 %
no limit
Tab. 2Current permitted upper limits for the use of titanium
dioxide and zinc oxide in sunscreen products globally
needed. However, organic sunscreens and boosters are also
compatible with zinc oxide and can combine to create formulations with a very high SPF and strong UVA protection as
illustrated in the formulations within this article.
Many dermatologists insist that mineral-based sunscreens
such as those made from zinc oxide and titanium dioxide are
the only real way to prevent skin damage and premature aging. The upper limit for the use of zinc oxide in the U.S. is
25 % for creams, gels, and lotions, but not for nano-sized
particles of zinc oxide in spray products. (Tab. 2)
For Europe, zinc oxide is expected to be listed in 2016 on Annex VI of EC/1223/2009 for approval for use at a limit of 25 %
concentration in member states. Only UV filters listed in the
Annex VI of EC/1223/2009 are allowed in cosmetics products
that are intended to be placed on the European beauty products market. For Australia and Japan there is no upper range
limit for zinc oxide.
Nanoparticles and Zinc Oxide
In top down processes, nanoparticles can be produced by wet
milling processes. In bottom up processes, crystalline or amorphous nanoparticles can be obtained by crystallization, precipitation, or vaporization processes. Particle shapes for zinc
oxide are described as nodular, rounded, or acicular.
The current accepted definition of a nanoparticle is an insoluble or bio-resistant and intentionally manufactured material
with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
The current assessment is that the use of zinc oxide nanoparticles, can be considered as safe for use on the skin in formulations such as sunscreen lotions or gels. As with other
nanoparticles, their use in sprays are not considered safe.
It is concluded on the basis of available evidence that the use
of ZnO nanoparticles with the characteristics as indicated, at a
concentration up to 25 % as a UV-filter in sunscreens, can be
considered not to pose a risk of adverse effects in humans after dermal application. This does not apply to other applications
that might lead to inhalation exposure to ZnO nanoparticles
(such as sprayable products). [5] Zinc oxide as a colorant in cosmetic products applied to the skin is also considered safe for use.
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sun care | personal care
UVA/UVB Balance
The solar spectrum at the earth’s surface (sea-level) consists
of wavelengths of electromagnetic energy only between 290
and 3000 nm, while the spectrum implicated in human skin
reactions involves wavelengths up to 1800 nm. [6]
Ultraviolet (UV) radiation is arbitrarily subdivided into three
bands, UVA (320–400 nm), UVB (290–320 nm) and UVC
(200–290 nm). UVA rays can be further subdivided into two
key wavelengths: short wave UVA (320–340 nm) and long
wave UVA (340–400 nm).
The European Commission recommends that sunscreens require a minimum UVA protection. This is essentially a UVA-PF
in vitro test that needs to yield a minimum value of at least
1/3 of the in vivo SPF result for the sunscreen tested. A critical
wavelength that is ≥ 370 nm is also required for Europe’s UVA
logo claims. In the U.S., an SPF ≥ 15 and a critical wavelength
≥ 370 nm is required for broad spectrum claims. [7]
Particle Engineering
Particle engineering is the science of modifying particles into
a defined shape, size distribution, and/or composition as well
as other aspects of the particle‘s morphology and surface
characteristics.
Particle shape depends upon the chemical and physical nature of the dispersed phase and the method employed to prepare the dispersion. Primary particles exist in a wide variety of
shapes and their aggregation produces an even wider variety
of shapes and structures. [8]
Primary particle size (PPS) is described as an average or mean
particle size of zinc oxide occurring as individual sized crystals.
During the manufacturing process, these crystals will adhere
and form aggregates and agglomerates.
The agglomerated particle size of the zinc oxide as a dry powder is often, but not always, a principal factor in determining its UV attenuation effect. Dispersion technology has been
known to apply shear to zinc oxide to optimize its particle size
in formulations.
U.S. Patent 9072918 is assigned to Kobo Products Inc. and it
teaches the use of multiple particle sizes of zinc oxide in order
to achieve a sunscreen that is balanced with respect to its
UVA and UVB properties. The first zinc oxide has an (APS) of
about 150 nm to about 260 nm and the (APS) for the second
zinc oxide is about 130 nm or smaller. [9]
The first and larger zinc oxide component can provide useful
UVA protection and the second and smaller zinc oxide component can provide useful UVB protection. Such a combination of components can provide effective broad-spectrum
protection against the UV components of atmospherically
filtered solar radiation.
The UV attenuation of zinc oxide depends more on its aggregate particle size than on the primary size. A transparent
sunscreen lotion with very balanced UV protection (SPF 30,
Ratio SPF/UVA-PF ≤ 3/1 ratio) was successfully formulated us21
personal care | sun care
ing a blend of zinc oxide with two different particle sizes as
shown in the patent.
The surfaces of the zinc oxide are typically treated with hydrophobic materials to create optimal dispersions which better
define the particle size distribution. These are commercially
available in dispersions in various natural oils, esters, and in
silicone fluids. The zinc oxide is also supplied including surface
treatments in a dry powder form to incorporate into formulations directly.
Non-Nano Zinc Oxide (Fig. 2)
content
length greater than 370 nm when used in conjunction with
organic sunscreens and boosters.
It can also be used without organic sunscreens if a mixture of
particles (nano and non-nano (micro)) of zinc oxide are used.
The combination of these particles assures a broad-band UV
protection. Utilization of zinc oxide powder blends and dispersions are described in U.S. Patent 9072918. The UV attenuation of zinc oxide depends more on its aggregate particle
size than the primary size.
Surface treatments of zinc oxide and dispersions of it in aqueous media, as well
as in various oils and esters enable the
formulator to find an optimal sunscreen
system for their needs and objective.
Pigment producers have been challenged to develop grades of zinc oxide
with a mean particle size over 100 nm,
while maintaining adequate UV-protecFormulations
tion and cosmetic acceptability.
The SCCS considers that the use of
On the following pages are examples of
Fig. 2 SEM image of treated non-nano
larger (non-nano) forms of ZnO as a
three sunscreen products incorporating
zinc oxide (ZnO-C) with a primary parUV-filter with a concentration up to
zinc oxide in a non-nano form. The SPF
ticle size of 100–400 nm
25 %, as stated in the SCCP clarificafor each was tested in vivo on a three
tion (SCCP/1215/09), is safe and is not
subject panel. Formula KSL-264 has an
of any additional safety concern compared to the nano-forms
SPF 38 and a critical wavelength of 373. Formula KSL-277A
assessed in this Opinion. [10]
has an SPF 60, UVA-PF 19, and a critical wavelength of 378.
Kobo Products offers a grade of zinc oxide, ZnO-C, as shown
Formula KSL-265 has an SPF 33, UVA-PF 11, and a critical
above, where the primary particle size is greater than 100
wavelength of 377. (Formulas on pages 24-25)
nanometers when measured by image analysis. This non-nano ZnO is available coated with either organic or inorganic
Bibliography
surface treatments, and also dispersed in various vehicles for
[1] David B. Troy, Remington: The Science and Practice of Pharmacy, Chapter 65:
use in formulations. These options will enable formulators to
Topical Drugs, Lippincott Williams & Wilkins (2006) p. 1283
develop sunscreen products with broad spectrum protection
[2] N
urit Beyth, Yael Houri-Haddad, Avi Domb, Wahid Khan, and Ronen Hazan, “Alternative Antimicrobial Approach: Nano-Antimicrobial Materials”, Evidence-Based Complewithout nanoparticles should they choose to do so. [11]
mentary and Alternative Medicine Volume 2015 (2015), Article ID 246012, 16 pages
Conclusion
Zinc oxide and titanium dioxide are frequently employed in
sunscreens as inorganic physical sun blockers. Titanium dioxide is somewhat more effective in UVB protection while
zinc oxide absorbs more broadly in the UVA range. However,
with the advent of sunscreen boosters, zinc oxide can be used
alone as the primary UVA/UVB active. There are some distinct
advantages in the lower refractive index and market acceptance of zinc oxide for formulators.
A labeling requirement has been in force since July 2013,
based on an EU Directive on cosmetics and body care products. If nano-sized ingredients are used in a product, the manufacturer must make this fact clear by adding “nano-“ to the
listed ingredient name.
Therefore, it is important to provide both formulators and
consumers with the option to choose between nanoparticle
containing products and those (non-nano) which do not contain these particles.
Zinc oxide with a non-nano particle size above 100 nm can
deliver effective UVA/UVB sunscreens with a critical wave22
[3]
Tenfga Long, Shu Yin, Kouta Takabatake, Peilin Zhnag, Tsugio Sato, “Synthesis and Characterization of ZnO Nanorods and Nanodisks from Zinc Chloride
Aqueous Solution”, Nanoscale Res Letter (2009) pp. 247-253
[4]European Scientific Committee on Emerging and Newly Identified Health Risks,
“Nano-form zinc oxide in sunscreens” (2012) p.98
[5]European Scientific Committee on Emerging and Newly Identified Health Risks,
“Nano-form zinc oxide in sunscreens” (2012) p.97
[6] K
ale S, Bhandare S, Gaikwad M, Urunkar V and Rajmane A, Formulation and in vitro sun
evaluation for sun protection factor of Leutein ester extracted from Tagetes erecta flower
(fam-Asteraceae) sunscreen cream, Res. J. Pharm. Bio. Chem Sci. 2(3), 2011, 947.
[7]COLIPA UV-A guideline: Method for the in vitro determination of UVA protection
provided by sunscreen products, 2007, The European Cosmetic Toiletry and Perfumery Association – COLIPA, Rue de la Loi 223/2, B-1040 Bruxelles (www.colipa.com)
[8] H
arry S. Katz, John V. Mileski,
Handbook of Fillers for Plastics,
3. Coloured Pigments, Van Nostrand Reinhold (1987) p.170
[9] D
avid Schlossman, Yun Shao, US
9072918 B2, “Method of formulating zinc oxide powder blends
for balanced UVA/UVB attenuation”, July 7, 2015
[10]
European Scientific Committee on Emerging and Newly
Identified Health Risks, “Nanoform zinc oxide in sunscreens”
(2012) p.98
[11]David Schlossman, Yun Shao,
US 20110150792 A1, “Zinc
oxide aqueous and non-aqueous dispersions”, June 23, 2011
contact
Edward Bartholomey | Principal Research Scientist
Stacey House | Applications Lab Manager
Fred Ortiz | Chemist
*
Kobo Products Inc.
3474 South Plainfield | New Jersey | U.S.A.
Tel: +1 908 757 0033
www.koboproducts.com
sofwjournal | 142 | 03/16
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content
personal care | sun care
Kobo Oil-in-Water Sunscreen Emulsion (Non-Nano Zinc Oxide Dispersion) – KSL-264
Part
1
2
3
4
5
Ingredients
Deionized Water
Liposorb® L-20
INCI Name
Water
Polysorbate 20
Propylene Glycol
Propylene Glycol
1.50
KELTROL® CG
Xanthan Gum
0.30
DIM2FH75NZCM
Zinc Oxide (and) Dimethicone (and) Isononyl Isononanoate (and)
Polyglyceryl-6 Polyricinoleate (and) PEG-10 Dimethicone (and) Hydrogen Dimethicone
12.75
Neo Heliopan® AV
HallBrite® BHB
Ceraphyl® 368
Lipo® GMS-450
Neo Heliopan® BBN
Finsolv® TN
Lipomulse® 165
Lipowax® D
Covi-ox® T-50
Liposorb® TS
Botanistat PF-64
Aculyn™ 44
Total
Percent
48.65
1.00
Ethylhexyl Methoxycinnamate
Butyloctyl Salicylate
Ethylhexyl Palmitate
Glyceryl Stearate
Benzophenone-3
C12-15 Alkyl Benzoate
Glyceryl Stearate (and) PEG-100 Stearate
Cetearyl Alcohol (and) Ceteareth-20
Tocopherol
Sorbitan Tristearate
Phenoxyethanol (and) Caprylyl Glycol (and) Ethylhexylglycerin (and) Hexylene Glycol
PEG-150/Decyl Alcohol/SDMI Copolymer
7.50
7.50
7.00
3.00
3.00
2.50
2.00
0.50
0.50
0.30
1.00
1.00
100.00 %
Procedure
1. In main kettle, combine Part 1 ingredients and heat to 78-80 °C.
2. Combine Part 2 ingredients and heat to 80 °C. Mix until uniform using propeller mixer.
3. Add Part 2 to Part 1 and mix until uniform.
4. Combine Part 3 ingredients. Heat to 80 °C and add to batch with propeller mixing.
5. Add Part 4 while cooling.
6. Homogenize for approximately 2 minutes at 4000 rpm (Silverson).
7. Add Part 5 to batch.
8. Homogenize for approximately 1 minute at 4000 rpm (Silverson).
9. Cool batch to 30 °C.
Kobo Water-in-Oil Sunscreen Emulsion (Non-Nano Zinc Oxide Dispersion) – KSL-277A
Part
1
2
Ingredients
Deionized Water
Sodium Chloride
Aculyn™ 44
Allantoin
Butylene Glycol
KELTROL® CG
TNP50T7
TNSS75MZCM
3
4
SunBoost ATB™
ABIL® EM90
SF1214
Tocopherol
Methyl Paraben NF
Propyl Paraben NF
MSS-500W
Total
INCI Name
Water
Sodium Chloride
PEG-150/Decyl Alcohol/SDMI Copolymer
Allantoin
Butylene Glycol
Xanthan Gum
C12-15 Alkyl Benzoate (and) Titanium Dioxide (and) Alumina (and) Polyhydroxystearic Acid
(and) Methicone
Zinc Oxide (and) Ethylhexyl Methoxycrylene (and) C12-15 Alkyl Benzoate (and)
Polyhydroxystearic Acid (and) Hydrogen Dimethicone
Argania Spinosa Kernel Oil (and) Tocopheryl Acetate (and) Bisabolol
Cetyl PEG/PPG-10/1 Dimethicone
Cyclopentasiloxane (and) Dimethicone
Tocopherol
Methylparaben
Propylparaben
Silica
Percent
29.20
0.50
0.50
0.20
2.00
0.10
32.00
25.60
3.60
3.00
2.00
0.30
0.15
0.10
0.75
100.00 %
Procedure
1. Combine Part 1 and heat to 70 °C.
2. Premix Part 2.
3. Add Part 2 to Part 1.
4. Combine Part 3 and heat to 70 °C.
5. Combine Parts 1 and 2 to Part 3 with propeller mixing. Homogenize.
6. Add Part 4 while cooling and homogenizing.
24
sofwjournal | 142 | 03/16
content
sun care | personal care
Kobo Oil-in-Water Sunscreen Emulsion (Non-Nano Zinc Oxide Powder ZnO-C-I2) – KSL-265
Part
1
2
3
4
5
6
Ingredients
INCI Name
Deionized Water
Water
Percent
47.42
Niacinamide USP/FCC
Powder
Niacinamide
5.00
Liposorb® L-20
Polysorbate 20
1.00
Methyl Paraben NF
Methylparaben
0.20
Glycerin U.S.P. Natural 96 % Glycerin
4.00
KELTROL CG
Xanthan Gum
0.20
Dermol 25B
C12-15 Alkyl Benzoate
10.23
HBP45TEL
Butyloctyl Salicylate (and) Titanium Dioxide (and) Alumina (and) Silica (and) Stearic Acid
(and) Polyhydroxystearic Acid
8.65
ZnO-C-I2
Zinc Oxide (and) Isopropyl Titanium Triisostearate
7.30
SunBoost ATB™
Argania Spinosa Kernel Oil (and) Tocopheryl Acetate (and) Bisabolol
5.00
Lipopeg® 100-S
PEG-100 Stearate
2.50
Lipo® GMS-450
Glyceryl Stearate
1.00
Shea Butter
Shea Butter
0.40
Propyl Paraben NF
Propylparaben
0.10
MSS-500W
Silica
3.00
Sepigel™ 305
Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7
1.00
Daitosol 5000AD
Acrylates Copolymer (and) Water
3.00
®
Total
100.00 %
Picture Credits: sekundator/Fotolia.com
Procedure
1. Combine Part 1 and heat to 70 °C.
2. Combine Part 2 ingredients and add to Part 1.
3. Combine Part 3 into a slurry and add to Parts 1and 2 while mixing.
4. Combine Part 4 ingredients and heat to 70 °C.
5. Add Part 4 to water phase (Parts 1-3) under homogenization.
6. Add Parts 5 and 6 while cooling.
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