The FDA requirements for sunscreens will undergo a major update in 2026, marking a new phase in the regulation of sunscreen products in the United States. With advances in scientific research and growing consumer safety awareness, the U.S. Food and Drug Administration (FDA) is gradually strengthening its oversight of sunscreen products. These new FDA requirements for sunscreens will directly impact product formulations, labeling standards, and market access. This article provides a detailed analysis of the upcoming FDA requirements for sunscreens, helping consumers and industry stakeholders better understand the new regulations.
Background of the FDA’s Updated Requirements for Sunscreens
In recent years, as research into the safety and efficacy of sunscreen ingredients has advanced, the FDA has come to recognize the need to update its existing regulatory framework. In 2019, the FDA issued a preliminary proposal on the safety and effectiveness of sunscreens. Following years of scientific evaluation and public consultation, the final version of the FDA’s requirements for sunscreens is expected to be fully implemented in 2026. These adjustments are designed to ensure that sunscreen products on the market are both safe and effective, while providing consumers with clearer and more useful information.
Key Changes to the FDA Sunscreen Requirements in 2026
1. Upgraded Ingredient Safety Standards
Under the latest FDA requirements for sunscreens, multiple chemical sunscreen ingredients previously deemed safe and effective will face stricter scrutiny. Common ingredients such as oxybenzone and octinoxate, which have been detected to be absorbed and retained by the human body, will be required to provide additional safety data. If manufacturers cannot demonstrate the safety of these ingredients with long-term use, they may be removed from the Generally Recognized as Safe and Effective (GRASE) list.
Meanwhile, mineral sunscreen ingredients such as zinc oxide and titanium dioxide will continue to be classified as GRASE, as they remain on the skin’s surface and are not absorbed by the body. This change in the FDA’s sunscreen requirements will prompt manufacturers to reevaluate product formulations and shift toward safer ingredient options.
2. Standardization and Transparency of Sunscreen Labeling
The new FDA requirements for sunscreens will overhaul product labeling rules significantly. All sunscreen products must clearly indicate their protection range:
- The “broad spectrum” label will be restricted to products that protect against both UVA and UVB radiation.
- Products with an SPF value above 60 will be limited to labeling “SPF 60+” to avoid giving consumers a false sense of security.
- All products must include a “skin cancer/skin aging warning” to remind consumers that sunscreen alone is not sufficient for full protection against UV damage.
These labeling changes are a critical part of the FDA’s sunscreen requirements, designed to help consumers make more informed purchasing decisions.
3. Clear Regulations on Dosage Forms and Application Methods
Under the new FDA requirements for sunscreens, only products in specific dosage forms may be classified as sunscreens, including creams, gels, sprays, sticks, and powders. However, spray sunscreen products will face additional regulations and must demonstrate that they can be applied evenly and achieve the labeled SPF value when used as directed.
In addition, the FDA’s sunscreen requirements will, for the first time, define standards for claims such as “waterproof” and “sweat-resistant.” If a product is labeled “waterproof,” it must specify the duration of effective protection (40 minutes or 80 minutes) and may not use misleading terms such as “all-day waterproof” or “completely waterproof.”
4. Strengthened Safety Testing Requirements
The FDA’s sunscreen requirements to be implemented in 2026 will include stricter safety assessment standards. All sunscreen active ingredients and finished products must undergo more comprehensive testing, including:
- Skin penetration studies to evaluate whether ingredients are absorbed into the bloodstream
- Photostability testing to ensure ingredients do not break down into harmful substances when exposed to sunlight
- Safety data from long-term repeated use
- Safety considerations for special populations (e.g., children, pregnant women)
These testing requirements are a core component of the FDA’s sunscreen requirements to ensure public health and safety.
Impact of the New Regulations on the Industry and Consumers
Impact on Manufacturers and Brands
The new FDA requirements for sunscreens mean many existing products may need reformulation or relabeling. Industry estimates suggest a transition period of 12–24 months may be required for full compliance. Smaller manufacturers may face greater challenges, as safety testing and formulation adjustments will increase costs. However, this also creates opportunities for innovation, driving the industry to develop safer and more effective sunscreen products.
Benefits to Consumers
The updated FDA requirements for sunscreens will ultimately benefit consumers. Stricter ingredient standards mean the overall safety of products on the market will improve. Standardized labeling will make it easier for consumers to compare different products and understand their actual protection capabilities. Clear warning statements will also help consumers recognize that sunscreen is only part of a comprehensive sun protection strategy, which should also include seeking shade, wearing protective clothing, and other measures.
How to Prepare for the 2026 Changes
Advice for Consumers
As the FDA’s sunscreen requirements are set to be updated, consumers can:
- Check product ingredient lists and prioritize mineral sunscreens containing zinc oxide or titanium dioxide
- Learn to read sunscreen labels correctly and understand the meaning of SPF values and broad-spectrum protection
- Build comprehensive sun protection habits and not rely solely on sunscreen
- Follow official FDA announcements for the latest safety information and recommendations
Preparation Advice for the Industry
Sunscreen product manufacturers should:
- Begin reviewing existing product formulations to assess their compliance with the new FDA sunscreen requirements
- Invest in necessary research and testing to ensure ingredient safety
- Design product packaging that meets the new labeling requirements in advance
- Consider a gradual transition to safer, more sustainable formulations
Summary
The 2026 FDA requirements for sunscreens mark a significant advancement in the regulation of sunscreen products in the United States. These evidence-based updates will elevate product safety standards, strengthen consumer protection, and drive product innovation. As the implementation date approaches, both consumers and the industry should proactively understand these changes to prepare for a smooth transition.
It is important to note that the FDAs requirements for sunscreens may continue to evolve. Further adjustments could be made in the future as scientific research progresses. Therefore, staying informed through official FDA communications is critical for all stakeholders.
Overall, the 2026 changes to the FDA’s sunscreen requirements represent the agency’s commitment to public health. By ensuring the safety and efficacy of sunscreen products, they help the public better protect themselves from UV damage, reducing the risk of skin cancer and premature aging. This series of updates to the FDA’s sunscreen requirements will ultimately create a more transparent and safer sunscreen market, enabling everyone to make more informed sun protection choices.
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