NATURALS SPF ■ % Boost ■
20.00 18.00 16.00 14.00 12.00 10.00 8.00 6.00 4.00 2.00 0.00
17.51% 15.26% 11.19% 33.41 37.51 38.51 39.26
40.00 39.00 38.00 37.00 36.00 35.00 34.00 33.00 32.00 31.00 30.00
Control Microcare 350 Naturesoft 860R Naturesoft 860S Figure 1: SPF boosting with organic sunscreens
■ Individuals with fair, uniformly coloured skin on the lower area of the back which would allow a discernable erythema ■ Individuals free of any dermatological or systemic disorder which, in the opinion of the testing personnel, would interfere with the results of the study ■ Individuals in good health who have completed a preliminary medical history ■ Individuals who have read, understood, and signed a consent document in compliance with 21 CFR 50
Exclusion criteria ■ Individuals with any visible skin disease at the study site, which in the opinion of the investigative personnel would interfere with the study results ■ Individuals taking medications which might affect study results e.g., Photosensitizers, antihistamines, analgesics, or anti-inflammatory drugs ■ Individuals who are pregnant, planning a pregnancy, or nursing a child ■ Individuals with a history of skin cancer ■ Individuals with a history of hepatitis or other blood disease ■ Individuals with a known sensitivity to
30.00 25.00 20.00 15.00 10.00 5.00 0.00
11.19% 15.26% 17.51%
45
SPF ■ % Boost ■ 28.11%
33.41 37.51 38.51 39.26 42.80
45.00 40.00 35.00 30.00 25.00 20.00 15.00 10.00 5.00 0.00
No booster Control/
Microcare 350
Naturesoft 860R
Naturesoft 860S
Naturesoft 880GT
Figure 2: FDA 2011 static SPF in vivo data of organic-based sunscreen with natural SPF boosters
cosmetics, skin care products, or topical drugs as related to product(s) being evaluated ■ Individuals with recent sun exposure on the areas to be tested
Light source A Xenon Arc Solar Simulator lamp, which has a continuous light spectrum in the UVA and UVB range (290-400 nanometers) was utilized. The spectral output of the solar simulator was filtered so that it meets the spectral output requirements for testing Sunscreen Drug Products for over- the-counter human use; FDA Final Monograph, 21 CFR Part 201.347 (i)(1), UV Source, Federal Register, Vol. 76, No. 117, June 17, 2011, and the International Sun Protection Factor (SPF) Test Method, May 2006.8
Test formulations Our natural fine powder test materials (rice bran wax, carnauba wax, and combination of rice bran wax and green tea leaf extract) were incorporated into both organic and inorganic (zinc oxide) sunscreen containing formulations as illustrated in Table 1, each at 5% w/w use level. Note that the base formulations were
intentionally designed to be very basic without additional emollients or other ingredients
possibly interfering with test results. The base formulation consists of a non-ionic, TEA stearate emulsion. Basic organic sunscreens were utilized as originally recommended in the original FDA monograph. Note that the tradenames in the tables reflect
the following: Microcare 350 = ultrafine carnauba wax powder, irregular shape; Naturesoft 860R = ultrafine rice bran wax powder, irregular shape; Naturesoft 860S = ultrafine rice bran wax powder, spherical shape.
Test results The first set of graphs shown in Figure 1 reflect in vivo static SPF testing results with our test materials with organic sunscreen blend. As shown in Figure 1, both the carnauba wax and rice bran wax powders significantly improved the SPF over the control (base formulation with only organic sunscreens), with the rice bran wax showing higher performance over the carnauba wax. Since the rice bran wax performed so well, we
decided to also test our composite of both rice bran wax and green tea leaf extract (Naturesoft 880GT), in the same organic sunscreen test formulation. Our theory was that the addition of a strong anti-inflammatory such as green tea
www.personalcaremagazine.com
March 2023 PERSONAL CARE
% SPF Boost
SPF Measurement
% SPF Boost
SPF Measurement
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103
