The following provisions apply to sunscreen products containing aminobenzoic acid, avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O, sulisobenzone, titanium dioxide, trolamine salicylate, or zinc oxide, alone or in combination. The provisions do not apply to sunscreen products marketed under approved new drug applications or abbreviated new drug applications.
Solar Simulator Emission Spectrum
Wavelength range (nm) | Percent erythemal contribution1 |
[LESS THAN]290 | [LESS THAN]0.1 |
290-300 | 1.0-8.0 |
290-310 | 49.0-65.0 |
290-320 | 85.0-90.0 |
290-330 | 91.5-95.5 |
290-340 | 94.0-97.0 |
290-400 | 99.9-100.0 |
1 Calculation of erythema action spectrum described in § 201.327(i)(1)(ii) of this section.
Where Vi([LAMBDA]) = erythema action spectrum weighting factor at each wavelength [LAMBDA]
I([LAMBDA]) = irradiance (Watts per square meter) at each wavelength [LAMBDA]
t = exposure time (seconds)
Erythema-effective dose (E) is expressed as effective Joules per square meter (J/m2-eff).
Composition of the Padimate O/oxybenzone SPF Standard
Ingredients | Percent by weight |
Part A: | |
Lanolin | 4.50 |
Cocoa butter | 2.00 |
Glyceryl monostearate | 3.00 |
Stearic acid | 2.00 |
Padimate O | 7.00 |
Oxybenzone | 3.00 |
Part B: | |
Purified water USP | 71.60 |
Sorbitol solution | 5.00 |
Triethanolamine, 99 percent | 1.00 |
Methylparaben | 0.30 |
Propylparaben | 0.10 |
Part C: | |
Benzyl alcohol | 0.50 |
Part D: | |
Purified water USP | QS1 |
1 Quantity sufficient to make 100 grams.
Step 1. Add the ingredients of Part A into a suitable stainless steel kettle equipped with a propeller agitator. Mix at 77 to 82 °C until uniform.
Step 2. Add the water of Part B into a suitable stainless steel kettle equipped with a propeller agitator and begin mixing at 77 to 82 °C. Add the remaining ingredients of Part B and mix until uniform.
Step 3. Add the batch of Step 1 to the batch of Step 2 and mix at 77 to 82 °C until smooth and uniform. Slowly cool the batch to 49 to 54 °C.
Step 4. Add the benzyl alcohol of Part C to the batch of Step 3 at 49 to 54 °C. Mix until uniform. Continue to cool batch to 35 to 41 °C.
Step 5. Add sufficient water of Part D to the batch of Step 4 at 35 to 41 °C to obtain 100 grams of SPF standard. Mix until uniform. Cool batch to 27 to 32 °C.
(i) Column | C-18, 250 millimeters (mm) length, 4.6 mm inner diameter (5 microns) |
(ii) Mobile Phase | 85:15:0.5 methanol: water: acetic acid |
(iii) Flow Rate | 1.5 milliliters (mL) per minute |
(iv) Temperature | Ambient |
(v) Detector | UV spectrophotometer at 308 nanometers |
(vi) Attenuation | As needed |
Where to = retention time for oxybenzone
tp = retention time for padimate O
Wo = oxybenzone peak width at baseline
Wp = padimate O peak width at baseline
If the resolution (R) is less than 3.0, adjust the mobile phase or replace the column.
For products with an expected SPF less than 8, administer UV doses that increase by 25 percent with each successive dose (i.e., 0.64X, 0.80X, 1.00X, 1.25X, and 1.56X). For products with an expected SPF from 8 to 15, administer UV doses that increase by 20 percent with each successive dose (i.e., 0.69X, 0.83X, 1.00X, 1.20X, and 1.44X). For products with an expected SPF higher than 15, administer UV doses that increase by 15 percent with each successive dose (i.e., 0.76X, 0.87X, 1.00X, 1.15X, and 1.32X).
and the standard deviation (s) from the SPFi values. Calculate the standard error (SE), which equals s/[RADIC]n (where n equals the number of subjects who provided valid test results). Obtain the t value from Student's t distribution table corresponding to the upper 5-percent point with n-1 degrees of freedom. Determine the labeled SPF value, which equals the largest whole number less than
In order for the SPF determination of a test product to be considered valid, the SPF value of the SPF standard should fall within the standard deviation range of the expected SPF (i.e., 16.3 ±3.43).
Step 1. Expose test sites to UV doses as described in paragraph (e) of this section.
The mean transmittance for each wavelength,
is the ratio of the mean of the C([LAMBDA]) values to the mean of the P([LAMBDA]) values, as follows:
Where n [GREATER THAN EQUAL TO]5
are converted into mean absorbance values,
at each wavelength by taking the negative logarithm of the mean transmittance value as follows:
Where [LAMBDA]c = critical wavelength
A([LAMBDA]) = mean absorbance at each wavelength
d[LAMBDA] = wavelength interval between measurements
A mean critical wavelength of 370 nm or greater is classified as broad spectrum protection.
21 C.F.R. §201.327