Why won't the FDA approve new sunscreens?

Author: Emory Collins  |  Last update: Thursday, January 1, 2026

Because the U.S. regulates sunscreen as a drug, not a cosmetic, the FDA asks companies to run extensive testing before sunscreen products can be approved and sold in the U.S., placing Americans behind other countries in the development of new sunscreen filters, the chemicals added to sunscreens to “absorb or block UV ...

Why has the FDA not approved new sunscreen?

The fact that sunscreen is classified as a drug in the US means it has to go through the same testing and safety protocols that the FDA requires in order to gain approval. Usually these tests need to be done on a wide pool of animals and then humans so it is very very costly.

When was the last time the US approved a new sunscreen filter?

The last time we had a new UV filter approved in the United States was 1999. The slow-moving, bureaucratic approval process filled with red tape has hamstrung innovation here in the United States and set us behind our peers across the world.

Can I sell sunscreen without FDA approval?

The good news is that unlike drugs, cosmetics in the US don't require pre-market approval from the FDA. This means you can launch your brand without waiting for FDA green light. As a cosmetic brand owner, you're responsible for ensuring your products are safe.

Why is the US behind on sunscreen?

At the root of the controversy is a 1938 U.S. law called the Federal Food, Drug, and Cosmetic Act that requires sunscreens to be classified as over-the-counter drugs rather than cosmetics.

Experts question why FDA won't approve new sunscreens

Why are European sunscreens better than US?

The EU regulates sunscreens as cosmetics, which allows more flexibility in which active ingredients sunscreen manufacturers can use to protect against UVA rays. The EU has 34 UV filters approved for use in sunscreens, compared to 16 in the U.S.

Which country use most sunscreen?

Revenue of the sun protection skin care market worldwide by country 2023. In 2023, the United States was the leading country in the sun protection skin care market by a considerable distance, with revenues amounting to nearly two billion U.S. dollars. It was followed by China and South Korea.

Is o two o FDA approved?

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, O. TWO. O MATTE LIP TINT KISS PROOF MASKPROOF 24H LONG LASTING LIQUID (VLG 1, VLG 2, VLG 3, VLG 4, VLG 5, VLG 6, VLG 7, VLG 8, VLG 9, VLG 10, VLG 11, VLG 12).

Is oxybenzone bad for skin?

Due to the health concerns associated with oxybenzone, EWG recommends consumers avoid sunscreens with oxybenzone. Octinoxate is a non-mineral UV filter. It is readily absorbed into the skin and continues to be absorbed after the sunscreen has been applied.

How to get your sunscreen FDA approved?

One of the key requirements is that sunscreens must be tested for their Sun Protection Factor (SPF) and broad-spectrum protection. The FDA also mandates that all sunscreens must undergo rigorous testing to verify these claims before they can be marketed.

What sunscreen does Michelle Obama use?

Cosmo names our CyberDERM Simply Zinc Ultra SPF 50 one of the best natural sunscreens you should already be using. Celebrity Facialist to Michelle Obama and Oprah Recommends Our CyberDERM Simply Zinc Ultra. Jennifer Brodeur, the celebrity facialist to both Oprah and Michelle Obama, shares her advice for great skin.

Is Korean sunscreen better than US sunscreen?

“The formulations are usually more elegant, often being lighter and less greasy compared to many American sunscreens. This makes them more appealing for daily use.” “They have positioned themselves as the highest standard for the global beauty industry that everyone else is trying to catch up to,” Dr.

What is the oldest brand of sunscreen?

1946: Swisschemist Franz Greiter develops and commercializes the first modern sunscreen, known as “Gletscher Crème,” or Glacier Cream. He names his brand Piz Buin in honor of the mountain he climbed. The brand still exists today with more effective variations of Glacier Cream.

Why are Japanese sunscreens better?

Japanese sunscreens also offer a sensorial experience, often featuring a milky, lightweight texture that effortlessly melts into the skin. Similar to Korean sunscreens, they frequently incorporate skin-nourishing ingredients like hyaluronic acid and antioxidants.

Are there any safe sunscreens?

Mineral sunscreens (i.e., physical sunscreens) are safer than chemical sunscreens for your health and the planet. They contain the minerals titanium dioxide and/or zinc oxide, which physically sit on the skin's surface (rather than penetrating the skin) and reflect or refract UV radiation from the skin.

Why are Americans eating a sunscreen ingredient?

Titanium dioxide is the ingredient in sunscreen that actually keeps the sun rays off your skin. But, a growing number of companies are using it to artificially brighten the colors of what your food, from frozen pizza to Skittles. There's lot of debate now over whether it's bad for you.

What is the least toxic sunscreen?

Our Top 8 Picks for Healthy, Non-Toxic Sunscreen:
  • Luminance Skincare Sunscreen.
  • Babo Botanicals Clear Zinc Sunscreen Stick.
  • Blissoma Light Shifting Facial Sunscreen + Moisturizer.
  • Earth Mama Organics Sunscreen.
  • Kari Gran Sunscreen.
  • Juice Beauty Sunscreen.
  • Badger Balm Natural & Organic Mineral Sunscreen.

Do we really need sunscreen?

Wearing sunscreen is one of the best — and easiest — ways to protect your skin's appearance and health at any age. Used regularly, sunscreen helps prevent sunburn, skin cancer and premature aging. To help make sunscreen a part of your daily routine, dermatologist Anna Chien addresses common concerns.

Why was oxybenzone banned?

Oxybenzone (BP-3) and octinoxate (OMC), two common sunscreen ingredients, were recently banned in Key West and Hawaii due to their toxic effects on marine ecosystems.

Is BLK FDA-approved?

A: Yes, All blk cosmetics products are FDA certified in the Philippines. You may verify this through the Philippine FDA website.

How to check if sunscreen is FDA-approved?

Verify the product.

The FDA regulates sunscreen products, it is highly advised to purchase only products that have been notified with the FDA. To check if a product is notified with the FDA, use the FDA Verification Portal feature accessible at https://verification.fda.gov.ph.

Is the O shot FDA-approved?

While the O-Shot and other growth factor injections are not FDA-approved, they are well-known and well-documented techniques used in a variety of fields for their remarkable effectiveness.

What is the number 1 sunscreen?

The Best Sunscreen
  • Top pick. Blue Lizard Sensitive Mineral Sunscreen SPF 50+ An easy-to-spread physical sunscreen. ...
  • Top pick. Banana Boat Light As Air SPF 50+ A nongreasy chemical sunscreen. ...
  • Budget pick. Equate Sport Broad Spectrum Sunscreen Value Size SPF 50. ...
  • Also great. Thrive Bodyshield SPF 50.

What did people use before sunscreen?

In 800 – 500 BC, the ancient Greeks used olive oil to protect their skin and also used it in their daily skin care routines. The women of Namibia coated their hair and skin in red paste called Otijize to ward off the sun. The concoction was a mixture of butter, fat, and red ochre.

Why is Korean sunscreen better than American?

At issue is not just whether people are using enough sunscreen, but what ingredients are in it. In countries such as Japan, South Korea, and France, sunscreens include newer chemical filters, some of which have been shown to provide broader protection against UV rays than those used in the U.S.

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