It’s summer, and that means it’s time for households to stock up on one of the most useful drugs there is: Sunscreen!

Yes, sunscreen counts as a drug, legally. According to the Food and Drug Administration, “In Europe and in some other countries, sunscreens are regulated as cosmetics, not as drugs, and are subject to different marketing requirements. Any sunscreen sold in the United States is regulated as a drug because it makes a drug claim—to help prevent sunburn or to decrease the risks of skin cancer and early skin aging caused by the sun.”

This applies to any cosmetics with a sunscreen component. If it has “SPF” on the label, or if there are sunburn-fighting ingredients in it, it’s a drug, as far as the United States is concerned.

What Is an SPF Number?

An SPF number is a rough guide to a sunscreen’s protective ability. It is NOT a guarantee, for example, of how long you can wear it without getting sunburned. People’s skin varies too much for any accurate prediction to be possible. SPF is a relative scale: a sunscreen with SPF 30 will block sun for twice as long as SPF 15, and the higher you go, the more sun protection you have.

In order to estimate how long your sunscreen will last, here’s a formula: if you start getting sunburned after five minutes without any sunscreen, an SPF 30 sunscreen would protect you for 30 times that long—that is, 30 times five minutes. You’d get 150 minutes, or 2 1/2 hours, of protection.

But even among sunscreen with the same SPF, not all are created equal. Consumers are advised to look for sunscreen that is “broad-spectrum,” meaning it protects against both UVA and UVB light. Sunscreens must be labeled whether they are broad-spectrum or not. Makeup can contain broad-spectrum sunscreen, as well. Whether you’re making SPF foundation, lipstick with sunscreen, or another product, as a Cosmetics Creator, it pays to be aware of the possibilities. That way, you can offer your customers the protection they are looking for in a product.

What Kind Of Testing Does Sunscreen Need To Undergo?

When manufacturing a sunscreen, close to the end of formulation, and before the graphics can be printed on the packaging/label, testing must be conducted to prove effectiveness, including SPF factor and water resistance.

The full guidelines for testing are available at the FDA’s website. This page — part of the Electronic Code of Federal Regulations — details what tests need to be performed, how to perform them, and what the labeling requirements need to be depending on the results.

The tests take place using laboratory equipment and on volunteer subjects. The subjects have sunscreen applied to them under lab conditions, then they are exposed to simulated sunlight and spend time in water to determine how well the formula being tested performs.

At the end of testing, it is determined how much protection the sunscreen can claim to offer, whether the sunscreen gives wide-spectrum protection, and whether it can claim to be water-resistant.

What Kinds of Sunscreen Are There?

Sunscreen comes in formats including lotions, sprays, and gels. Each kind has its own directions for use, so packaging must clearly say the correct way to apply the sunscreen.

In addition, many moisturizers and cosmetic products are marketed as containing sunscreen. These are usually indicated by an SPF designation; for instance, many foundations advertise an SPF of 15, and several offer higher protection than that.

As a Cosmetics Creator, you are likely interested in this kind of sunscreen: the kind that has a skin-care or beauty use as well as a sun-protection factor.

What Are Some Of the Important Rules for Marketing Sunscreen?

The FDA has several rules for sunscreen marketing, and some of the more prominent are spelled out in a regulation that came into effect in 2011. The FDA says that these are that regulation’s main points:

• Broad-spectrum designation. Broad spectrum testing measures a product's UVA protection relative to its UVB protection, If a product passes tests, it may be labeled on the front as "Broad Spectrum SPF [value]."
  For broad-spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. If a broad-spectrum product has an SPF over 15, it may make additional claims, as follows:
• Use claims. Broad-spectrum sunscreens with SPF of 15 or higher may claim to reduce the risk of skin cancer and early skin aging, if they are used as directed with other sun protection measures. Sunscreens that are not broad-spectrum or have an SPF value of 2 to 14 may only claim to help prevent sunburn.
• "Waterproof," "sweatproof," or "sunblock" claims. Manufacturers cannot label sunscreens as "waterproof" or "sweatproof," or identify their products as "sunblocks," because this is an overstatement. No product is truly waterproof, and none blocks all sun; they all wash off, and they all lose effectiveness over time.
  Sunscreens also may not claim that they protect from the sun for longer than 2 hours without being reapplied, or that they protect immediately after they are put on (for example, "instant protection"), unless they submit data to support these claims and obtain FDA approval.
• Water-resistance claims. Water-resistance claims on the front label must state whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water-resistant must instruct consumers to use a water-resistant sunscreen if they are swimming or sweating.
• Drug Facts. All sunscreens must include standard "Drug Facts" information on the back and/or side of the container.

This is not a complete list of the standards that sunscreen and packaging must meet. This is a detailed regulatory matter, and it’s important to get it right. We suggest that you work with a reputable, experienced regulatory consultant to ensure that your sunscreen product follows all the rules. This goes double because of the evolving regulations surrounding sunscreen marketing.

Sunscreen Is a Drug? What Does That Mean?

Because sunscreen is a “drug,” it has to be labeled as a drug and must meet FDA standards for safety and efficacy (called a “GRASE” designation) established in an official document called a “monograph.” Drugs that don’t fit an existing monograph have to go through the New Drug Application (NDA) process.

With sunscreen, this status has been evolving for quite some time. There has never been a monograph for over-the-counter sunscreen, but one has been in the works since at least the 1990s. In its place, the FDA says it has “historically exercised enforcement discretion with respect to certain OTC sunscreen products marketed without approved new drug applications.” In other words, it has not objected to new sunscreens being put on the market even if they don’t have an approved NDA, and it has enforced the regulations on a case-by-case basis. However, in a consumer-facing article, the FDA states that “sunscreens must pass certain tests before they are sold.”

The FDA apparently has not issued many updates about the process for a couple of years, as of summer 2021. A clue to why may be found here:

On March 27, 2020, the President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act into law. This act is intended to modernize the process by which FDA regulates over-the-counter monograph drugs. The FDA is in the process of implementing the changes set forth in the act and will update the public and this webpage as we have additional information.

This law contains a section specifically on the process for approving sunscreen. As noted above, according to the most recent FDA news, the agency was still implementing the changes.

How Do I Work SPF into My Formulation?

Goldn is building the first-ever all-in-one digital cosmetics-creation environment, including smart tools to help you build your dream product and take it to market. We are also building functionality to help you collaborate with suppliers, including formulation and regulatory consultants, whose business is to help your Cosmetics Brand succeed.

Sign up here so you know as soon as we’re live. You’ll be welcome to take part in the cosmetics-creation process of the future!