What Is the Rule for Sunscreen?

Sunscreen is an essential part of protecting your skin from harmful UV rays, reducing the risk of sunburn, premature aging, and skin cancer. But understanding the rules and regulations around sunscreen can be tricky, especially if you’re looking to sell or distribute sunscreens. Whether you’re marketing your own brand of sunscreen or considering custom sunscreens as a promotional product, knowing the regulations is crucial to ensure safety and compliance with the law.

In this blog post, we’ll dive into the rules for sunscreen, including FDA regulations, labeling requirements, and best practices for choosing and using sunscreens to protect your skin.

FDA Regulations for Sunscreen: What You Need to Know

In the United States, sunscreen is regulated as an over-the-counter (OTC) drug by the Food and Drug Administration (FDA). This means that any product marketed as a sunscreen must meet certain standards regarding ingredients, testing, and labeling to ensure consumer safety.

1. Sunscreen Ingredients

The FDA has approved a specific list of active ingredients that are considered safe and effective for use in sunscreens. Some of the most common FDA-approved sunscreen ingredients include:

• Zinc Oxide: A mineral-based ingredient that provides broad-spectrum protection by reflecting UV rays.
• Titanium Dioxide: Another mineral ingredient that physically blocks UV rays and is less likely to irritate sensitive skin.
• Avobenzone: A chemical sunscreen ingredient that absorbs UVA rays.
• Octocrylene and Octinoxate: Chemical compounds that absorb UVB rays and prevent skin damage.

If you’re considering custom sunscreens for your brand, make sure the product uses FDA-approved ingredients to meet safety and effectiveness guidelines.

2. SPF Testing Requirements

The Sun Protection Factor (SPF) indicates how well a sunscreen protects against UVB rays, which cause sunburn and contribute to skin cancer. Sunscreens must undergo rigorous testing to determine their SPF rating, which is then displayed on the packaging.

• SPF 15 filters about 93% of UVB rays.
• SPF 30 filters about 97% of UVB rays.
• SPF 50 filters about 98% of UVB rays.

It’s important to note that no sunscreen can block 100% of UV rays. The FDA requires that sunscreen manufacturers properly test their products to determine accurate SPF values. If your company plans to sell or distribute custom sunscreens, ensure that the SPF claims on the product are backed by proper testing and compliance with FDA guidelines.

3. Broad-Spectrum Protection

In addition to protecting against UVB rays, sunscreens labeled as broad-spectrum must also protect against UVA rays. UVA rays penetrate deeper into the skin and contribute to premature aging, wrinkles, and skin cancer. For a sunscreen to be labeled "broad-spectrum," it must pass a specific test showing it provides adequate UVA protection.

Offering custom sunscreens with broad-spectrum protection is a great way to emphasize skin safety and ensure your promotional product aligns with consumer health expectations.

4. Water Resistance Claims

If a sunscreen is marketed as "water-resistant," the label must specify whether the protection lasts for 40 or 80 minutes while swimming or sweating. The FDA has strict regulations about water resistance claims, and sunscreens that are not water-resistant must include a warning on the label instructing users to reapply after swimming or sweating.

Avoid terms like "waterproof" or "sweatproof," as the FDA no longer allows these claims—they can be misleading and give users a false sense of prolonged protection.

5. Labeling Requirements

The FDA has detailed guidelines on how sunscreen products must be labeled to ensure they provide clear and accurate information to consumers. These labeling rules include:

• SPF Rating: Clearly indicating the SPF number on the front of the packaging.
• Broad-Spectrum Labeling: If applicable, the product must state whether it offers broad-spectrum protection.
• Water Resistance: Indicating whether the product is water-resistant and how long that protection lasts (40 or 80 minutes).
• Usage Instructions: Labels must clearly instruct users on how to apply and when to reapply the sunscreen for optimal protection.
• Warning Statements: Sunscreens that are not broad-spectrum or have an SPF below 15 must include a warning that the product only protects against sunburn, not skin cancer or skin aging.

Ensuring that your custom sunscreens are labeled in compliance with FDA regulations is essential, whether you’re selling them or giving them away as part of a promotional campaign.

Can You Sell Sunscreen Without FDA Approval?

Because sunscreen is classified as an over-the-counter drug in the U.S., you cannot sell sunscreen without FDA approval. However, if you’re creating a private label or custom sunscreen product through a third-party manufacturer, you can rely on their FDA approval, assuming they meet the proper requirements for testing, labeling, and safety.

It’s critical to work with manufacturers who understand FDA regulations and have already undergone the necessary testing and approval processes for their sunscreen products. This ensures that your brand’s sunscreen is not only effective but also compliant with U.S. laws.

Best Practices for Using Sunscreen

Now that we’ve covered the regulatory side, let’s discuss some of the best practices for using sunscreen to get the most protection for your skin.

1. Apply Generously

Most people don’t apply enough sunscreen to get the full benefit of the SPF listed on the label. The general rule of thumb is to use about one ounce of sunscreen (approximately a shot glass full) to cover your entire body. Apply the sunscreen 15 to 30 minutes before sun exposure to allow the ingredients to fully absorb.

2. Reapply Frequently

Even if your sunscreen is labeled as water-resistant, it’s important to reapply after swimming, sweating, or towel drying. As a rule, reapply sunscreen every two hours, especially if you’re spending time outdoors.

3. Use Sunscreen Year-Round

UV rays can cause skin damage even on cloudy days and during the colder months. Make sunscreen a daily habit, especially on exposed areas like your face, neck, and hands.

4. Don’t Rely Solely on Sunscreen

While sunscreen is a crucial tool for protecting your skin, it’s also important to use other forms of sun protection. This includes wearing protective clothing, sunglasses, and wide-brimmed hats, and seeking shade during peak sun hours (10 AM to 4 PM).

Why Custom Sunscreens Make Great Promotional Products

For businesses, custom sunscreens are an excellent promotional item because they provide a useful, health-focused product that customers will appreciate. With increasing awareness around the dangers of sun exposure, offering branded sunscreens is a practical way to show that your company cares about the well-being of its customers or employees.

Custom-branded sunscreens can be distributed at outdoor events, sports competitions, travel destinations, or corporate wellness programs. When clients use your branded sunscreen, they’ll be reminded of your company every time they protect their skin—making it a great long-term promotional item.

Considerations for Custom Sunscreens:

• SPF Rating: Choose sunscreens with at least SPF 30 to ensure adequate protection for your customers.
• Broad-Spectrum: Opt for a sunscreen that provides broad-spectrum protection to shield users from both UVA and UVB rays.
• Eco-Friendly Options: Look for custom sunscreens that are reef-safe, meaning they don’t contain harmful ingredients like oxybenzone or octinoxate, which can damage coral reefs.

Conclusion

Sunscreen is more than just a skincare product—it’s a crucial part of protecting your skin from harmful UV rays. Whether you’re using sunscreen personally or distributing custom sunscreens for your brand, it’s essential to understand the FDA rules and guidelines that ensure product safety and effectiveness. By selecting sunscreens with proper SPF, broad-spectrum protection, and water resistance, you can help protect your customers’ skin while also promoting your business.

Need help? Talk to an expert now at 1-888-377-9339 or Email us at care@qualityimprint.com.