Federal health regulators have signed off on the first new sunscreen ingredient for the U.S. market in more than 25 years.

Federal health regulators on Tuesday signed off on the first new sunscreen ingredient for the U.S. market in more than 25 years, giving Americans access to a skin-protecting chemical long used in Europe and other parts of the world.

The Food and Drug Administration says the ingredient, bemotrizinol, met the agency’s standards for protecting from dangerous ultraviolet rays while causing little irritation or absorption into the skin. The ingredient is safe for adults and children 6 months and older, the agency stated in a release.

Bemotrizinol will initially be sold in the U.S. by the Dutch manufacturer DSM Nutritional Products under the brand name Parsol Shield, which is expected to launch later in the year. After an 18-month exclusivity period, the ingredient will be available for use by other manufacturers.

  • velma@lemmy.blahaj.zoneEnglish
    1·
    28 days ago

    This ingredient has been used in sunscreens for decades outside of the US.

    Between various countries’ regulatory approval and real-world use, bemotrizinol has some of the most robust safety and efficacy testing among sunscreen filters. Following the ingredient’s development in the late 1990s by the now defunct Switzerland-based company Ciba Specialty Chemicals, the European Union adopted it into sunscreens in 2000. Canada and several countries in Asia followed suit soon after.

    “A ton of safety data have had to be accrued in a lot of different populations,” Wyles says. Companies developing sunscreen filters need lots of funding to get the data needed for approval in the U.S., she adds.

    Not only is bemotrizinol now the first filter to obtain the FDA’s stamp of approval since 1999, it’s also the first and only organic filter to receive the FDA’s safety and effectiveness standard, known as generally recognized as safe and effective (GRASE), for over-the-counter drugs or ingredients that don’t require full regulatory approval. The GRASE designation “is huge,” Addae says.

    “I think that will kind of debunk the consumer’s perception that inorganic filters are generally recognized as safe and effective and organic filters tend to not be,” she says. “This shows that there can be organic filters that are that are determined GRASE.”

    • teyrnon@sh.itjust.worksEnglish
      01·
      28 days ago

      The FDA is not a reliable source. And they pay researchers to work backwards from it’s safe to it’s use. How do you not question this by now?

      Maybe you are partially right, none of what you cited is even remotely proving that, only that you trust the wrong people, frankly.

      • velma@lemmy.blahaj.zoneEnglish
        1·
        28 days ago

        I’m not trusting the FDA, I’m trusting other countries methods of approving this particular ingredient.

        The FDA is decades late on approving this ingredient.

        • teyrnon@sh.itjust.worksEnglish
          01·
          28 days ago

          I don’t trust any governments, rather nonprofits and orgs like consumer reports. We will see.

              • velma@lemmy.blahaj.zoneEnglish
                0·
                28 days ago

                Be content to sit in the dark then.

                No one is going to deliver this info to you on a silver platter, especially if you’re unwilling to search for the info yourself.

                • teyrnon@sh.itjust.worksEnglish
                  01·
                  28 days ago

                  I do embrace the darkness, it’s not evil, not bad, without the darkness there would be no life.

                  But if you mean to speak ignorance, ha. The government is not a reliable source, the mercenary science outfits that serve corpos aren’t either.

                  So what is your point here? Because the government and corpos tell you something is safe I can’t wait until a credible source confirms it? How dare I express distrust in the system?

                  Either of those questions from you, would discredit you.

                  • velma@lemmy.blahaj.zoneEnglish
                    1·
                    28 days ago

                    No one is stopping you from going out in the sun with no protection and getting as much skin cancer as you can possibly soak up.

                    Spreading doubt without information is conspiracy theory-minded. Bring some data to back up your assertions before you start turning people away from something that has helped save lives.