Advanced Sunscreen SPF 30+

Sunscreens are widely recommended by the medical community and consumers have become more educated and well aware of the importance of using sunscreen in their daily routine. The proper use of sunscreens may help to prevent skin damage and may help reduce the risk of skin lesions, skin cancer and other disease conditions.

Applying sunscreen daily may also help to slow down the signs of aging. Through the combination of research and development and the use of a patented encapsulation technology, Novasome® Technology, Miaj has developed a sunscreen product that not only gives you the full benefits of sun protection but also gives you everyday protection
from the environment.

Main Factors that Contribute photo-aging UV radiation: Ultraviolet radiation is composed of three types of wavelengths, UVC (200-290nm), UVB (290-320 nm) and UVA (320-400 nm). Our atmosphere only blocks
UVC, so UVB and UVA do reach the surface of the earth.
UVB penetrates only into the epidermis, while UVA penetrates all the way to the dermis.2 UVB rays are known to cause burning while UVA rays are known to cause photoaging.
Exposure to ultraviolet (UV) radiation increases skin pigmentation and usually results in an even darkening of the skin. It may also occasionally lead to the development of hyperpigmented lesions due to local overproduction of pigment. Skin pigmentation is induced both by UVB and UVA rays.11 The interaction of UV radiation and skin type plays a central role in melanoma formation. Mortality from melanoma is highest in geographic location near the equator, where UV intensity is greatest. The incidence of melanomas in light-complected individuals (skin type I-III) is several times higher than those with darker skin types (types IV-VI), even in similar geographic regions. The combination of UVB and UVA exposure are responsible for skin cancer formation and photoaging. Sunscreens have now been shown to reduce the carcinogenic effects of sunlight in human.12

Sunscreen and Novasome® Technology

Novasome® Technology: Novasomes® are nonphospholipid lipid vesicles that are paucilamellar lipid spherules. Novasome® vesicles have one or several lipid bilayer membranes surrounding a large amorphous core, which can be considered to be a cargo hold for the chemical entity encapsulated. Novasomes® have an excellent safety profile and they have applications in the pharmaceuticals, cosmetic, personal care, food, chemical and agrochemical industries.4-6 The application of lipid vesicle encapsulation for cosmetic ingredients is fairly widespread and has become popular as an aid to stabilize formulations, improve delivery, reduce irritation, improve aesthetics, and in some cases, as controlled release systems.7,8 To reduce irritancy, aid in formulation and improve delivery, we encapsulated the chemical sunscreens to produce a cosmetic formula with a SPF of 30 and desirable aesthetic properties.
Preparation: To formulate a SPF sunscreen, a formulator should always take into consideration the incorporation of sunscreen actives that will protect the skin against UVB and UVA rays.The FDA has published a Final Monograph which details the sunscreen actives that can be used in OTC sunscreens in the US.3 Using Novasome® Technology in encapsulating these actives, we used the minimal amount of sunscreen actives that would provide SPF 30. This has been proven with independent studies done comparing the same amount of actives in traditional emulsion vs. the Novasome® Technology. The result the studies concluded the use of Novasomes® increase the SPF value by 40%.
Novasomes® are prepared uisng Miaj's proprietary method.
In this case, Novasomes® were constituted with the following sunscreen actives; octyl methoxycinnamate (7.5%, w/w), octyl salicylate (5%, w/w) and avobenzone (3%, w/w), to provide a SPF of 30 with both UV-A and UV-B
protection.

Antioxidants in Sunscreen Formula

Antioxidants:
Vitamin E and botanical extracts such as Green Tea and White Tea extracts are all examples of antioxidants that act as a free radical scavengers. These antioxidants when added in the formula gives skin added protection against the environment .

Vitamin E (alpha-tocopherol):
Vitamin E is the most common non-enzymatic radical scavenger involved in protecting living tissue against oxidative stress and radical damage. As an antioxidant, it protects other fat soluble vitamins from oxidative damage. It is necessary for tissue repair; it is a natural anticoagulant and promotes healing. The predominant form of vitamin E in human and animal tissues is alpha tocopherol.
Daily use of sunscreen products with antioxidants like tocopherol acetate following exposure to UVB significantly reduce erythema index by 40-55%.13 Incorporating tocopherol acetate in the formula also increases the concentration of free tocopherol in the skin.

Botanicals:
Plant extracts have been widely used as topical applications for wound-healing and anti-aging. A short list of phenolic phytochemicals with promising properties to benefit human health includes a group of polyphenol compounds, called catechins, found in green tea and white tea. Green Tea and White Tea Extracts are naturally derived compounds effective in soothing, moisturizing and protecting skin from the environment. Green Tea is consumed worldwide because of its characteristic aroma and health benefits. The epicatechin derivatives, commonly called polyphenols, present in green tea and even more in white tea possess antioxidant, anti-inflammatory and anti-carcinogenic properties. Clinical and biological studies have implicated that solar ultraviolet (UV) light is a complete carcinogen and repeated exposure can lead to the development of various skin disorders including melanoma and nonmelanoma skin cancers. Topical treatment and oral consumption of green tea polyphenols (GTP) inhibit chemical carcinogen.15-17
Antioxidant and anti-inflammatory effects of green tea and white tea were observed in human skin. Green tea and white tea are ideal for all skin types to make skin more resistant against damaging "environmental influences".18

Clinical Testing of Sunscreen Products

By law, every sunscreen product that claims sunscreen protection should undergo Sunscreen Protection Factor (SPF) testing following FDA proposed monograph for OTC sunscreen products. The test subjects all had skin type I-III and exhibited no skin abnormalities. Initially, the minimal erythemal dose (MED) was determined for each subject, by exposing areas of untreated skin to a Xenon Arc Solar Stimulator (150W) at incremental increases in energy and evaluating the minimal amount of irradiation needed to produce erythema 24-hours later. To test the sunscreen, the material was applied to skin between the scapulae and the belt-line, lateral to the midline, at a dose of 2mg/cm2, the area was subdivided and irradiated so that different areas received increasingly greater doses of UV energy. In addition, a standard sunscreen formulation (8% Homosalate) was run as a control on the same subjects. The MED was also determined on untreated skin close to the test sites. The degree of erythema was evaluated 24-hours later for all test sites. The SPF was calculated from the ratio of the energy needed to produce MED on protected skin to the amount of energy needed to produce MED on untreated skin.

Conclusion:

Ratings and tests for the effectiveness of sunscreens are becoming more consistent and scientifically based. This reflects the growing recognition of the health hazards from sunburn and excessive tanning. Health professionals should
be aware of the classic six skin types and their susceptibility to burning, as well as Sun Protection Factors (SPFs).14 Miaj's sunscreen product provides true broadspectrum UVA/UVB protection in a proprietary delivery system. The product is cosmetically elegant, rich with vitamin E, green tea and white tea extracts and provides your skin with extra protection not only from the sun, but also from our everyday environment.

References

1. 64 FR 27666. May 21,1999
2. Caswell, Ph.D, Michael. Ph.D."Sunscreen Formulations & Tanning Formulations" , Chapter 4 in Volume 2 of the third edition of The Chemistry and Manufacture of Cosmetics.
3. Fed Reg 64(98) 27666-27693 (May 21, 1999)
4. Wallach DFH. "Method of producing high-aqueous volume multilamellar vesicles". US Patent 4,855,090.
5. Wallach DFH, Philippot J. "New type of lipid vesicle: NovasomeTM". In; Liposome Technology, 2nd Edition; Gregorriadis G. CRC Press, Boca Raton, FL. 1982, pp.141-151.
6. Niemiec SM, Ramachandran C, Weiner N. "Influence of nonionic liposomal vivo study using the hamster ear model." Pharmaceutical Research 1995, 12 (8), 1184-1188.
7. Alfieri DR. "AHAs and nonphospholipid liposomes." Cosmetic Dermatology 1997, 10, 42-52.
8. Rogers K. "Controlled release technology and delivery systems". Cosmetics and Toiletries. 1999, 114 (5), 53-60.
9. 21 CFR 330.10(a)(6) Advance Notice of Proposed Rulemaking to establish a monograph for OTC sunscreen drug products. August 25, 1978
10. 59 FR 29706. June 8, 1994.
11. Pharmacother, Ann.1996 Jun;30(6):662-73. PMID:15379874
12. Photodermatol Photoimmunol Photomed. 2004 Oct;20(5):243-7.PMID: 8792954
13. Arch Biochem Biophys. 1992 Aug 1;296(2):575-82.PMID:1632644
14. Prof. Care Mother Child. 1998;8(3):79-80 .PMID: 9814358
15. Curr Drug Targets Immune Endocr Metabol Disord. 2003 Sep;3(3):234-42. PMID:12871030
16. J Am Acad Dermatol.2005 Jun:52(6):1049-59.PMID:15929624
17. Dermatol Surg.2005 Jul;31(7 Pt 2):855-60.PMID: 16029678
18. Art N0:NA20747, Crodarom
19. CRL Study#: CRL89003, CRL89103 & CRL83399