China Clarifies Sunscreen Labeling Requirements

CFDA’s announcement on June 1 relating to new sunscreen labeling requirements indicated that when measured SPF is between 2 and 30, products shall be marked with the measured value. The clause on labelling requirements is particularly confusing for both consumers and manufacturers which neglect the possible SPF error measured by the testing institutions. To respond to industry’s concern, on Aug 15th CFDA released a notification to further specify the labeling requirements.

According to the notification, products with SPF≥2 are subject to the following rules:

1. Measured SPF =2-5 (including 2 and 5): indication of the actual measured value
2. Measured SPF=6-50 (including 6 and 50): the maximum labeling SPF shall be actual measured value; the minimum labeling SPF shall be the smaller number comparing the lower limit of 95% confidence intervals of the actual measured value with the largest integer (less than the actual measured value) of multiple of 5
3. Measured SPF > 50 and the lower limit of 95% confidence intervals of the actual measured value > 50: indication of “SPF 50+”;
4. Measured SPF > 50 and the lower limit of 95% confidence intervals of the actual measured value≤50, the maximum labeling SPF shall be “SPF 50+”, the minimum labeling SPF shall be the lower limit of 95% confidence intervals of the actual measured value.

Stipulation No.2 is complicated. Here are two examples to help clarify the criteria:

Generally the testing reports in China will indicate the actual measured value and 95% confidence interval.

1. If the actual measured value is 11 and the 95% confidence intervals is 9.66-12.26,

• The lower limit of 95% confidence intervals is 9.66
• The largest integer (less than the actual measured value) of multiple of 5 is 10

So the maximum permitted SPF on a label is 11, the minimum SPF is 9.66. Normally companies will use a whole number. In conclusion, companies can mark 10 or 11.

2. If the actual measured value is 24 and and the 95% confidence intervals is 22.40-25.56,

• The lower limit of 95% confidence intervals is 22.40
• The largest integer (less than the actual measured value) of multiple of 5 is 20

The maximum SPF is 24, the minimum SPF is 20. In conclusion, companies can mark 20, 21, 22, 23 and 24.