1. Consumer Products and UV Protection
Mr. Donald Rick

2. US federal Food, Drug, and Cosmetic Act
The term "drug" means... (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.

3. US federal Food, Drug, and Cosmetic Act
The term "cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance
Show examples of products. What makes a product a drug vs cosmetic. Ingredients vs intended uses.

4. Electromagnetic spectrum
E= hv = hc/λ

6. This map is provided courtesy of the National Oceanic and Atmospheric Administration (NOAA) and the Environmental Protection Agency (EPA). Data Description: This map represents UV intensities at solar noon / approximate noon local standard time or 1.00 pm local daylight time. The NOAA/EPA UV Index is computed using the forecasted ozone data, a radiative transfer model, forecasted cloud amounts and the elevation of the forecast cities. Total ozone amounts for the entire globe are obtained via the TOVS (TIROS Operational Vertical Sounder) or the SBUV/2 (Solar Backscatter UltraViolet/2) instruments on board NOAA polar orbiting satellites. The observed data is then used to produce a forecast of the ozone data for tomorrow. This is done using the thermal-dynamical relationship between total ozone and heights at 100 and 500 hPa and temperatures at 50 hPa. NCEP provides the necessary analyzes and forecasts to determine the forecasted ozone data. This forecasted ozone data has been shown to be much more accurate than using only persistence. A radiative transfer model is used to determine the UV irradiances from 290 to 400 nm, using the time of day (solar noon), day of year, and latitude. The irradiances are weighted by the Erythema action spectrum so as to reflect the human skins response to each wavelength. The computation of the UV Index does not include the effects of variable surface reflection, atmospheric pollutants or haze.

8. UV Breakdown UVC: < 290 nm UVB: 290 – 320 nm UVA: 320 – 400 nm
UVC : High Energy UV, Does not Reach Earth Surface
UVB : UV Range Most Important for Burning
UVA : UV Range For Chronic Effects “Aging”

9. SPF What is it? SPF = Σ [E(λ) B(λ)] / Σ [E(λ) B(λ)/ PF(λ)]
SPF = Minimal Erythema Dose in Sunscreen Protected Skin
Minimal Erythema Dose in non Sunscreen Protected Skin
Dosage = 2 mg / cm2
400
400
SPF = Σ [E(λ) B(λ)] / Σ [E(λ) B(λ)/ PF(λ)]
E(λ) = Spectral Irradiance of Sunlight
B(λ) = Relative Effectiveness at wavelength λ in producing Erythema
(Erythema Action Spectra)
PF(λ) = Protection Factor at wavelength λ
290
290

10. Solar UV Spectrum
The intensity of UV radiation reaching the Earth's surface is not uniform in UV wavelength components. Due to ozone absorption, UV rays with wavelengths shorter than 290nm (often classified as the UV-C range) are of negligible intensity. For the intermediate UV-B range ( nm) the ozone absorption is substantial, but UV radiation still reaches the Earth's surface. The UV-A range ( nm) is absorbed little by the Earth's ozone layer.  The graph shows the relative Solar UV Spectrum for three ozone thicknesses: 2.0, 2.6, 4.0 mm. (Data from Green Model, noon time, clear sky, latitude 40o, equinox. Ozone thicknesses taken from Dobson Unit definition. Curves normalized to 1 at 400nm.)

11. Erythemal Response Spectrum
Exposing skin to UV light leads to redness or burning once a threshold dose has been exceeded. However, sunburn is not simply proportional to the total absorbed energy of ultraviolet light. Skin sensitivity to Erythema depends strongly on the UV wavelength. Although overall sensitivity to sunburning varies among individuals, the relative sensitivities to separate wavelengths remain the same. The Erythemal Response Spectrum (shown on the graph) demonstrates erythemal skin sensitivity for every UV wavelength.

12. Effective UV Spectrum
The Effective UV Spectrum is the mathematical product of the Solar UV Spectrum and the Erythemal Response Spectrum. It can be interpreted as the "skin burning intensity" of individual wavelengths of sunlight. Sunburn is induced mostly by the nm UV. In other words, focusing on measurements within the nm range should be of concern. The graph shows the Effective UV Spectrum for three ozone thicknesses: 2.0, 2.6, 4.0 mm. Thinning of the ozone layer leads to an abrupt increase of UV-B in the Effective UV Spectrum.

13. Transmittance = P / P0
% Transmittance = 100T
Absorbance = log10 P0 / P
Absorbance = log10 1/T

14. Beer-Lambert Equation
A = εcb
A = Absorbance
ε = Molecular Absorptivity ( L / mol cm)
b = Path Length (cm)
c = Concentration (mol / L)

15. UV-vis spectroscopy probes the electronic transitions of a molecule
UV-vis spectroscopy probes the electronic transitions of a molecule. The "electronic transitions" of a molecule depends on the bond structure of the molecule. To be able to access bonding information using UV or visible light, the molecule must have a series of alternating double and single bonds, called an extended Pi system because of molecular orbitals alternating double and single bonds represent.
Benzene is the classic example of a molecule with an extended Pi system, as can be seen from its circular arrangement of alternating double and single bonds
This UV-vis spectrum of benzene is fairly typical of modern UV spectra. The absorbance of the sample is plotted vs. wavelength as is typical , but an average UV-vis spectrum usually goes from approximately 200 nm up to 800 nm, rather than just 160 nm to 210 nm in a UV spectrum. The broad peaks shown above are characteristic of UV absorption, but the bumpiness of benzene between 190 nm to 200 nm is worth noting. Because UV-vis absorption occurs as a result of electronic absorption and subsequent excitation into a higher-energy orbital, it can be surmised that the "bumps" are a result of several specific electronic transitions occurring in the cyclic conjugated Pi system of benzene.

21. SPF Correlation to % UVB Blocked
sunscreen with an SPF of x blocks a proportion (x−1)/x of UVB
Sun Protection Factor
Proportion of UVB blocked
Proportion of UVB Blocked
SPF 10
90.0%
SPF 20
95.0%
SPF 30
96.7%
SPF 60
97.0%

22. Graph comparing coverage in male (M) and female (F) patients by site
Gaughan, M. D. et al. Arch Dermatol 1998;134:
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23. Subject graded as having adequate coverage of his forehead, nose, and cheeks
Gaughan, M. D. et al. Arch Dermatol 1998;134:
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24. The amount of sunscreen needed to be applied to each body area to reach approximately 2 mg/cm2 and to achieve the full rated sun protection factor
Schneider, J. Arch Dermatol 2002;138:838-b-839-b.
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26. Product Development Formulation Development Toxicology
Clinical (Efficacy, Safety, Consumer)
Claim Support
COGs
Regulatory (Claims and Labeling)
Manufacturing