CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR352.73]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 352 -- SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]

Subpart D - Testing Procedures

Sec. 352.73 Determination of SPF value.

(a)(1) The following erythema action spectrum shall be used to calculate the erythema effective exposure of a solar simulator:

Vi (λ) = 1.0 (250 <λ <298 nm)

Vi (λ) = 1.00.094 (298 - l) (298 <λ <328 nanometers)

Vi (λ) = 1.00.015 (139 - l) (328 <λ <400 nanometers)

(2) The data contained in this action spectrum are to be used as spectral weighting factors to calculate the erythema effective exposure of a solar simulator as follows:

(b) Determination of MED of the unprotected skin. A series of UV radiation exposures expressed as Joules per square meter (adjusted to the erythema action spectrum calculated according to § 352.73(a)) is administered to the subsite areas on each subject with an accurately calibrated solar simulator. A series of five exposures shall be administered to the untreated, unprotected skin to determine the subject's inherent MED. The doses selected shall be a geometric series represented by (1.25 ⁿ), wherein each exposure time interval is 25 percent greater than the previous time to maintain the same relative uncertainty (expressed as a constant percentage), independent of the subject's sensitivity to UV radiation, regardless of whether the subject has a high or low MED. Usually, the MED of a person's unprotected skin is determined the day prior to testing a product. This MED(US) shall be used in the determination of the series of UV radiation exposures to be administered to the protected site in subsequent testing. The MED(US) should be determined again on the same day as the standard and test sunscreens and this MED(US) should be used in calculating the SPF.

(c) Determination of individual SPF values. A series of UV radiation exposures expressed as Joules per square meter (adjusted to the erythema action spectrum calculated according to § 352.73(a)) is administered to the subsite areas on each subject with an accurately-calibrated solar simulator. A series of seven exposures shall be administered to the protected test sites to determine the MED of the protected skin (MED(PS)). The doses selected shall consist of a geometric series of five exposures, where the middle exposure is placed to yield the expected SPF plus two other exposures placed symmetrically around the middle exposure. The exact series of exposures to be given to the protected skin shall be determined by the previously established MED(US) and the expected SPF of the test sunscreen. For products with an expected SPF less than 8, the exposures shall be the MED(US) times 0.64X, 0.80X, 0.90X, 1.00X, 1.10X, 1.25X, and 1.56X, where X equals the expected SPF of the test product. For products with an expected SPF between 8 and 15, the exposures shall be the MED(US) times 0.69X, 0.83X, 0.91X, 1.00X, 1.09X, 1.20X, and 1.44X, where X equals the expected SPF of the test product. For products with an expected SPF greater that 15, the exposures shall be the MED(US) times 0.76X, 0.87X, 0.93X, 1.00X, 1.07X, 1.15X, and 1.32X, where X equals the expected SPF of the test product. The MED is the quantity of erythema-effective energy required to produce the first perceptible, unambiguous redness reaction with clearly defined borders at 22 to 24 hours postexposure. The SPF value of the test sunscreen is then calculated from the dose of UV radiation required to produce the MED of the protected skin and from the dose of UV radiation required to produce the MED of the unprotected skin (control site) as follows:

SPF value = the ratio of erythema effective exposure (Joules per square meter) (MED(PS)) to the erythema effective exposure (Joules per square meter) (MED(US)).

(d) Determination of the test product's SPF value and PCD. Use data from at least 20 test subjects with n representing the number of subjects used. First, for each subject, compute the SPF value as stated in § 352.73(b) and (c). Second, compute the mean SPF value, x
, and the standard deviation, s, for these subjects. Third, obtain the upper 5-percent point from the t distribution table with n-1 degrees of freedom. Denote this value by t. Fourth, compute ts/ â??n. Denote this quantity by A (i.e. , A = ts/ â??n). Fifth, calculate the SPF value to be used in labeling as follows: the label SPF equals the largest whole number less than x
. - A. Sixth and last, the drug product is classified into a PCD as follows: if 30 + A , the PCD is High; if 12 + A <30 + A, the PCD is Moderate; if 2 + A <12 + A, the PCD is Minimal; if x
<2 + A, the product shall not be labeled as a sunscreen drug product and shall not display an SPF value.