FDA Rule for Broad-spectrum Labeling: Key Substrate Findings

Oct 1, 2011 | Contact Author | By: Dominique Lutz, Julie Ongenaed and Celine Guy, HelioScreen Labs
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Title: FDA Rule for Broad-spectrum Labeling: Key Substrate Findings
in vitrox FDA regulationx critical wavelengthx UVAx sunscreen evaluationx PMMA substratex roughnessx
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Keywords: in vitro | FDA regulation | critical wavelength | UVA | sunscreen evaluation | PMMA substrate | roughness

Abstract: UVA protection is part of the mandatory testing for claiming broad-spectrum sun protection. A worldwide standardization is in development with the ISO TC217, expected for UVA testing 2012. The FDA has issued a final rule following Colipa’s proposed UVA in vitro method. While this rule establishes UVA labeling and testing, inconsistencies remain. This study compares the critical wavelength in roughness and application before and after two levels of UV doses.

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D Lutz, J Ongenaed and C Guy, FDA Rule for Broad-spectrum Labeling: Key Substrate Findings, Cosm & Toil 126(10) 732 (2011)

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Although UVB represents the harmful part of the ultraviolet (UV) spectrum, UVA also needs to be considered in the global protection against sun exposure. There is a consensus on this, and recommendations or regulations on UVA protection are being taken into account throughout the world.

The in vivo persistent pigment darkening (PPD) method, proposed by the Japan Cosmetic Industry Association (JCIA),1 among several other proposals, is the one that has been recommended by the European Union (EU) Commission2 and now also in the imminent publication of 24442 International Organization for Standardization (ISO) normalization.

In the meantime, in vivo testing has also been challenged for ethical reasons due to the conditions of testing. In 2006, the EU Commission2 recommended in vitro method adoption as soon as possible, stating preference be given to in vitro testing methods delivering equivalent results, as in vivo methods raise ethical concerns. Proposals of in vitro methods had been made by BL Diffey and Robson on the principle of transmission measurement of a thin film spread on a substrate.3 The photostability that affects the level of UVA protection may or may not be taken into account. In case, a specific step of irradiation is defined. Different criteria to measure the broadness of absorbance4 or the balance between UVA/UVB5 had also been proposed.

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Table 1a. HD6 plates (5 µ roughness) complied with specifications of the COLIPA and ISO following the control card.

Table 1a. HD6 plates (5 µ roughness) complied with specifications of the COLIPA and ISO following the control card.

Molded HD2 and HD6 plates were used (see Table 1a and 1b).

Table 1b. HD2 plates (2 µ roughness) complied with the following control card.

Table 1b. HD2 plates (2 µ roughness) complied with the following control card.

Molded HD2 and HD6 plates were used (see Table 1a and 1b).

Table 2. Total irradiance corresponding to wavelengths with a threshold of 500 W/m2

Table 2. Total irradiance corresponding to wavelengths with a threshold of 500 W/m<sup>2</sup>

Total irradiance was limited to 500W/m², which produces 71.3 W/m² in the testing device used following calibration (see Table 2).

Table 3. Results of intra plate dispersions within the plates

Table 3. Results of intra plate dispersions within the plates

Table 3 shows the results for each assay and the statistical results.

Table 4. Intra and inter plates variability for different plates types and amount of product

Table 4. Intra and inter plates variability for different plates types and amount of product

As is demonstrated in Table 4, in using this formulation there is a low dispersion on the CW results’ intra or inter plates.

Table 5. CW values before and after UV exposure for the two types of plates, two rates of product application and two UV doses used

Table 5. CW values before and after UV exposure for the two types of plates, two rates of product application and two UV doses used

Table 5 shows the results of CW measurements. W

Table 6. Expression of the difference of CW after irradiation depending on the level of irradiation

Table 6. Expression of the difference of CW after irradiation depending on the level of irradiation

For the two types of roughness, Table 6 reports the evolutions of CW values, in both cases 2µm and (expressed as the difference of CW values before and after irradiation), for the two levels of irradiation 8 J/cm² and 22 J/cm².

Figure 1. 95% confidence level (CL) of intra plate dispersion depending on roughness/quantity.

Figure 1. 95% confidence level (CL) of intra plate dispersion depending on roughness/quantity.

Not only is the dispersion better for the 5 µm, but it is also more regular with the lower quantity (0.75 mg/cm²) as shown in Figure 1, which is the expression of the minimum and maximum value of the confident interval for each roughness and quantity.

Footnotes (CT1110 Lutz)

a Products of HelioScreen Labs, Creil, France.
b A UV2000S spectrophotometer manufactured by Labsphere Inc., North Sutton, New Hampshire, USA, was used.
c Suntest CPS+ is a testing device manufactured by Atlas Material Testing Technology, Chicago, USA.

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