Amount of sunscreen usage during peoples’ lifetime has substantially increased with the hike in the number of skin cancer cases over the years. To maintain the safety of several products containing sunscreen active ingredients, the Food and Drug Administration (FDA) proposed new rules in February of 2019.
According to the rule, when such ingredients enter the bloodstream and reach a level of 0.5 ng/mL or higher, it raises safety concerns that need further investigation. Before conclusively stating the new regulations, the FDA recommended conducting more assessments. This is to determine whether the ingredients increase risk of suffering adverse effects, cancer, birth defects and other diseases.
Last Year’s Pilot Study:
The FDA started its process of examination with a pilot study that was published last May. By employing a standardardized method to assess the impact of drugs absorbed by the body, referred to as the maximal usage trial (MUsT), four sunscreen active ingredients (avobenzone, oxybenzone, octocrylene, and ecamsule) were checked. Ingredients in various forms of sunscreen products available in the market were assessed.
“All of the active ingredients in the study noted above were absorbed in levels substantially higher than the 0.5 ng/mL threshold value cited in the proposed rule. However, without further testing, FDA does not know what levels of absorption can be considered safe,” the FDA announced last year in a news release.
What The Latest FDA Study Revealed:
To have a more in-depth understanding of the consequences of using too much sunscreen, the FDA conducted another study recently. This was a randomized clinical trial of 48 participants in good health. The goal was to study the systemic absorption and plasma concentration from six sunscreen active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate).
Subjects of the study were randomized into four groups based on four forms of commercial sunscreen products (lotion, aerosol spray, nonaerosol spray and pump spray) between January and February 2019. This took place in a clinical pharmacology unit located in West Bend, Wisconsin.
“Sunscreen product was applied at 2 mg/cm2 to 75% of body surface area at 0 hours on day 1 and 4 times on day 2 through day 4 at 2-hour intervals, and 34 blood samples were collected over 21 days from each participant,” the authors stated in the study published in the JAMA Network.
While some of the plasma concentrations were much higher than the safety threshold, the FDA vouches for the products’ safety. For example, oxybenzone concentrations in lotion were at 258.1 ng/mL and were at 180.1 ng/mL for aerosol spray.
However, the FDA said that these concentration levels are not poisonous and do not pose a risk to health since no complications were observed in the participants. The agency added it continues to recommend sunscreen to protect the skin from ultraviolet rays, in addition to wearing protective clothing.
Only 14 participants developed rashes, which was the most common adverse event observed. No other side effects were noted. The FDA maintained that it was still a high priority to establish concrete marketing standards for sunscreen. They are still committed to finding more data on the safety of all 16 sunscreen active ingredients.
Leave a Reply