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Introduction

Zinc oxide (C.I. Pigment White 4 – 77947) and titanium di-oxide (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 envi-ronmentally 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 proper-ties to reduce infections. [2]

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

the “American process” produces the product directly made from the ore. Both are vaporization type processes using fur-naces. 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 depo-sition, spray pyrolysis, thermal evaporation, and wet-chemical route etc. The wet chemical route has become a best prac-tice method for engineered ZnO nanoparticles because of the mild reaction conditions and simplicity of the synthesis pro-cess. Zinc acetate and zinc nitrate are used as starting materi-

A Balanced Approach for Formulating Sunscreen Products Using Zinc OxideE. 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. Par-

ticle 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.

Fig. 1 Zinc oxide – Primary particle size (PPS) at 20 nm (left – nodular) and (right – acicular) 60 nm

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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 charac-ter, 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 re-activity 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 hy-droxide 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 ad-dition 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 pow-ders. Upon heating they may react with possible ignition.Aluminum powders are sometimes used in eye cosmetic products. Surface treatments, such as triethoxycaprylylsilane or dimethi-cone, 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 deter-mine the final opacity of the pigment and can increase transparency.

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 com-pared to many other cosmetic materials.

Sunscreens

Zinc oxide powders having different particle sizes, or size distribu-tions can be chosen to selectively attenuate UV rays. This is ac-complished 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, titani-um 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 for-mulate 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

Tab. 1 Mohs scale of hardness for minerals

Value Material1 (Softest) Talc

2 Hexagonal boron nitride, Mica (2.0–2.5)

3 Calcite (calcium carbonate), Barium sulfate

4 Zinc oxide (4.5), Hydrated silica dioxide (2.5–5.0)

5 Iron oxide Fe3O4 (5.5), Titanium dioxide (5.5) (Anatase)

6 Titanium dioxide (6.5) (Rutile)7 Tin oxide8 Zirconium oxide9 Alumina (9.25)10 (Hardest) Diamond

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needed. However, organic sunscreens and boosters are also compatible with zinc oxide and can combine to create for-mulations 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 ag-ing. 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 An-nex 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 prod-ucts 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 amor-phous nanoparticles can be obtained by crystallization, pre-cipitation, or vaporization processes. Particle shapes for zinc oxide are described as nodular, rounded, or acicular. The current accepted definition of a nanoparticle is an insol-uble or bio-resistant and intentionally manufactured material with one or more external dimensions, or an internal struc-ture, on the scale from 1 to 100 nm.The current assessment is that the use of zinc oxide nanopar-ticles, can be considered as safe for use on the skin in for-mulations 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 af-ter 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 cos-metic products applied to the skin is also considered safe for use.

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 re-quire 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 na-ture of the dispersed phase and the method employed to pre-pare 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 pow-der is often, but not always, a principal factor in determin-ing 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 com-ponent can provide useful UVB protection. Such a combina-tion 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 ag-gregate 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 us-

Tab. 2 Current permitted upper limits for the use of titanium dioxide and zinc oxide in sunscreen products globally

TiO2 ZnOBrazil < 25 % <25 %US < 25 % <25 %

EU < 25 %<25 %

approval pendingJapan no limit no limitChina < 25 % <25 %Canada < 25 % <25 %Australia < 25 % no limit

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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 hydro-phobic 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 formula-tions directly.

Non-Nano Zinc Oxide (Fig. 2)

Pigment producers have been chal-lenged to develop grades of zinc oxide with a mean particle size over 100 nm, while maintaining adequate UV-protec-tion and cosmetic acceptability. The SCCS considers that the use of larger (non-nano) forms of ZnO as a UV-filter with a concentration up to 25 %, as stated in the SCCP clarifica-tion (SCCP/1215/09), is safe and is not of any additional safety concern compared to the nano-forms assessed in this Opinion. [10]Kobo Products offers a grade of zinc oxide, ZnO-C, as shown above, where the primary particle size is greater than 100 nanometers when measured by image analysis. This non-na-no ZnO is available coated with either organic or inorganic surface treatments, and also dispersed in various vehicles for use in formulations. These options will enable formulators to develop sunscreen products with broad spectrum protection without nanoparticles should they choose to do so. [11]

Conclusion Zinc oxide and titanium dioxide are frequently employed in sunscreens as inorganic physical sun blockers. Titanium di-oxide 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 accep-tance 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 prod-ucts. If nano-sized ingredients are used in a product, the man-ufacturer 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 con-tain these particles.Zinc oxide with a non-nano particle size above 100 nm can deliver effective UVA/UVB sunscreens with a critical wave-

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 dis-persions are described in U.S. Patent 9072918. The UV atten-uation of zinc oxide depends more on its aggregate particle

size than the primary size.Surface treatments of zinc oxide and dis-persions 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.

Formulations

On the following pages are examples of three sunscreen products incorporating zinc oxide in a non-nano form. The SPF for each was tested in vivo on a three subject panel. Formula KSL-264 has an

SPF 38 and a critical wavelength of 373. Formula KSL-277A has an SPF 60, UVA-PF 19, and a critical wavelength of 378. Formula KSL-265 has an SPF 33, UVA-PF 11, and a critical wavelength of 377. (Formulas on pages 24-25)

Bibliography

[1] David B. Troy, Remington: The Science and Practice of Pharmacy, Chapter 65: Topical Drugs, Lippincott Williams & Wilkins (2006) p. 1283

[2] Nurit Beyth, Yael Houri-Haddad, Avi Domb, Wahid Khan, and Ronen Hazan, “Alterna-tive Antimicrobial Approach: Nano-Antimicrobial Materials”, Evidence-Based Comple-mentary and Alternative Medicine Volume 2015 (2015), Article ID 246012, 16 pages

[3] Tenfga Long, Shu Yin, Kouta Takabatake, Peilin Zhnag, Tsugio Sato, “Synthe-sis 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] Kale 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 Perfu-mery Association – COLIPA, Rue de la Loi 223/2, B-1040 Bruxelles (www.colipa.com)

[8] Harry S. Katz, John V. Mileski, Handbook of Fillers for Plastics, 3. Coloured Pigments, Van Nos-trand Reinhold (1987) p.170

[9] David Schlossman, Yun Shao, US 9072918 B2, “Method of formu-lating zinc oxide powder blends for balanced UVA/UVB attenuati-on”, July 7, 2015

[10] European Scientific Commit-tee on Emerging and Newly Identified Health Risks, “Nano-form zinc oxide in sunscreens” (2012) p.98

[11] David Schlossman, Yun Shao, US 20110150792 A1, “Zinc oxide aqueous and non-aque-ous dispersions”, June 23, 2011

Fig. 2 SEM image of treated non-nano zinc oxide (ZnO-C) with a primary par-ticle size of 100–400 nm

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 0033www.koboproducts.com

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Kobo Oil-in-Water Sunscreen Emulsion (Non-Nano Zinc Oxide Dispersion) – KSL-264Part Ingredients INCI Name Percent

1Deionized Water Water 48.65

Liposorb® L-20 Polysorbate 20 1.00

2Propylene Glycol Propylene Glycol 1.50

KELTROL® CG Xanthan Gum 0.30

3

DIM2FH75NZCMZinc Oxide (and) Dimethicone (and) Isononyl Isononanoate (and) Polyglyceryl-6 Polyricinoleate (and) PEG-10 Dimethicone (and) Hydrogen Dimethicone

12.75

Neo Heliopan® AV Ethylhexyl Methoxycinnamate 7.50

HallBrite® BHB Butyloctyl Salicylate 7.50

Ceraphyl® 368 Ethylhexyl Palmitate 7.00

Lipo® GMS-450 Glyceryl Stearate 3.00

Neo Heliopan® BBN Benzophenone-3 3.00

Finsolv® TN C12-15 Alkyl Benzoate 2.50

Lipomulse® 165 Glyceryl Stearate (and) PEG-100 Stearate 2.00

Lipowax® D Cetearyl Alcohol (and) Ceteareth-20 0.50

Covi-ox® T-50 Tocopherol 0.50

Liposorb® TS Sorbitan Tristearate 0.30

4 Botanistat PF-64 Phenoxyethanol (and) Caprylyl Glycol (and) Ethylhexylglycerin (and) Hexylene Glycol 1.00

5 Aculyn™ 44 PEG-150/Decyl Alcohol/SDMI Copolymer 1.00

Total 100.00 % Procedure1. 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-277APart Ingredients INCI Name Percent

1

Deionized Water Water 29.20

Sodium Chloride Sodium Chloride 0.50

Aculyn™ 44 PEG-150/Decyl Alcohol/SDMI Copolymer 0.50

Allantoin Allantoin 0.20

2Butylene Glycol Butylene Glycol 2.00

KELTROL® CG Xanthan Gum 0.10

3

TNP50T7 C12-15 Alkyl Benzoate (and) Titanium Dioxide (and) Alumina (and) Polyhydroxystearic Acid (and) Methicone

32.00

TNSS75MZCM Zinc Oxide (and) Ethylhexyl Methoxycrylene (and) C12-15 Alkyl Benzoate (and) Polyhydroxystearic Acid (and) Hydrogen Dimethicone

25.60

SunBoost ATB™ Argania Spinosa Kernel Oil (and) Tocopheryl Acetate (and) Bisabolol 3.60

ABIL® EM90 Cetyl PEG/PPG-10/1 Dimethicone 3.00

SF1214 Cyclopentasiloxane (and) Dimethicone 2.00

Tocopherol Tocopherol 0.30

Methyl Paraben NF Methylparaben 0.15

Propyl Paraben NF Propylparaben 0.10

4 MSS-500W Silica 0.75

Total 100.00 % Procedure1. 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.

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Kobo Oil-in-Water Sunscreen Emulsion (Non-Nano Zinc Oxide Powder ZnO-C-I2) – KSL-265 Part Ingredients INCI Name Percent

1Deionized Water Water 47.42

Niacinamide USP/FCC Powder

Niacinamide 5.00

2Liposorb® L-20 Polysorbate 20 1.00

Methyl Paraben NF Methylparaben 0.20

3Glycerin U.S.P. Natural 96 % Glycerin 4.00

KELTROL® CG Xanthan Gum 0.20

4

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

5MSS-500W Silica 3.00

Sepigel™ 305 Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7 1.00

6 Daitosol 5000AD Acrylates Copolymer (and) Water 3.00

Total 100.00 %Procedure1. 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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