21 CFR § 352.70 - Standard sunscreen.

# 352.70 Standard sunscreen.

(a) *Laboratory validation.* A standard sunscreen shall be used concomitantly in the testing procedures for determining the SPF value of a sunscreen drug product to ensure the uniform evaluation of sunscreen drug products. The standard sunscreen shall be an 8-percent homosalate preparation with a mean SPF value of 4.47 (standard deviation  = 1.279). In order for the SPF determination of a test product to be considered valid, the SPF of the standard sunscreen must fall within the standard deviation range of the expected SPF (*i.e.*, 4.47 ±1.279) and the 95-percent confidence interval for the mean SPF must contain the value 4.

(b) *Preparation of the standard homosalate sunscreen.* (1) The standard homosalate sunscreen is prepared from two different preparations (preparation A and preparation B) with the following compositions:

Composition of Preparation A and Preparation B of the Standard Sunscreen

| Ingredients | Percent by weight |
| --- | --- |
| Preparation A |  |
| Lanolin | 5.00 |
| Homosalate | 8.00 |
| White petrolatum | 2.50 |
| Stearic acid | 4.00 |
| Propylparaben | 0.05 |
| Preparation B |  |
| Methylparaben | 0.10 |
| Edetate disodium | 0.05 |
| Propylene glycol | 5.00 |
| Triethanolamine | 1.00 |
| Purified water U.S.P | 74.30 |

(2) Preparation A and preparation B are heated separately to 77 to 82 °C, with constant stirring, until the contents of each part are solubilized. Add preparation A slowly to preparation B while stirring. Continue stirring until the emulsion formed is cooled to room temperature (15 to 30 °C). Add sufficient purified water to obtain 100 grams of standard sunscreen preparation.

(c) *Assay of the standard homosalate sunscreen.* Assay the standard homosalate sunscreen preparation by the following method to ensure proper concentration:

(1) *Preparation of the assay solvent.* The solvent consists of 1 percent glacial acetic acid (V/V) in denatured ethanol. The denatured ethanol should not contain a UV radiation absorbing denaturant.

(2) *Preparation of a 1-percent solution of the standard homosalate sunscreen preparation.* Accurately weigh 1 gram of the standard homosalate sunscreen preparation into a 100-milliliter volumetric flask. Add 50 milliliters of the assay solvent. Heat on a steam bath and mix well. Cool the solution to room temperature (15 to 30 °C). Then dilute the solution to volume with the assay solvent and mix well to make a 1-percent solution.

(3) *Preparation of the test solution (1:50 dilution of the 1-percent solution).* Filter a portion of the 1-percent solution through number 1 filter paper. Discard the first 10 to 15 milliliters of the filtrate. Collect the next 20 milliliters of the filtrate (second collection). Add 1 milliliter of the second collection of the filtrate to a 50-milliliter volumetric flask. Dilute this solution to volume with assay solvent and mix well. This is the test solution (1:50 dilution of the 1-percent solution).

(4) *Spectrophotometric determination.* The absorbance of the test solution is measured in a suitable double beam spectrophotometer with the assay solvent and reference beam at a wavelength near 306 nanometers.

(5) *Calculation of the concentration of homosalate.* The concentration of homosalate is determined by the following formula which takes into consideration the absorbance of the sample of the test solution, the dilution of the 1-percent solution (1:50), the weight of the sample of the standard homosalate sunscreen preparation (1 gram), and the standard absorbance value (172) of homosalate as determined by averaging the absorbance of a large number of batches of raw homosalate:

Concentration of homosalate = absorbance × 50 × 100 × 172 = percent concentration by weight.