Planning to sell sunscreen in the US? FDA regulations can be confusing, especially when choosing ingredients, testing SPF, and preparing product labels.
The FDA regulates sunscreen as an over-the-counter (OTC) drug. Your product must meet specific requirements for ingredients, testing, manufacturing, and labeling before entering the US market.
At TY Cosmetic, we’ve worked with third-party laboratories to evaluate sunscreen SPF, skin compatibility, and product performance. We know how much proper testing and clear documentation matter when developing products for different markets.
Below, we’ll explain the key FDA sunscreen requirements and what you should check before launching your brand.
1. What Are the FDA Regulations for Sunscreen?
In the US, sunscreen is an OTC drug, not just a cosmetic.
Why does this matter? Because sunscreen protects against UV radiation, the FDA regulates how it is formulated, tested, manufactured, and labeled.
The main framework is the FDA’s OTC Sunscreen Monograph M020, along with other applicable drug regulations.
Key FDA Sunscreen Requirements
| Requirement | What Your Brand Needs |
| Active Ingredients | UV filters permitted under applicable FDA rules |
| SPF Testing | Test results supporting the labeled SPF |
| Broad-Spectrum Testing | Required testing before making a Broad Spectrum claim |
| Labeling | Correct Drug Facts, directions, and warnings |
| Water Resistance | Testing to support 40- or 80-minute claims |
| Manufacturing | Compliance with applicable current Good Manufacturing Practices (cGMP) |
| Registration and Listing | Required drug establishment registration and product listing |
These requirements affect sunscreen lotions, creams, sprays, and other eligible formats.
Does FDA Registration Mean Your Sunscreen Is Approved?
No. FDA registration and FDA approval are different.
A manufacturer may have a registered facility, but that doesn’t automatically mean every sunscreen it produces is FDA-approved.
I often see brands misunderstand this distinction. Before placing an order, I recommend checking the manufacturer’s registration information, laboratory reports, and product compliance documents.
It’s a simple step that can prevent expensive problems later.
2. Which Sunscreen Ingredients Are Allowed by the FDA?
Not every sunscreen ingredient used internationally can be used in the US under the same conditions.
A formula developed for Europe or Asia may need changes before entering the American market.
Here are some common sunscreen ingredients and their regulatory status.
Common Sunscreen Active Ingredients
| Ingredient | Main Function | FDA Regulatory Status |
| Zinc Oxide | Broad UVA and UVB protection | Recognized as GRASE |
| Titanium Dioxide | Mineral UV protection | Recognized as GRASE |
| Avobenzone | UVA protection | Permitted under specified conditions; additional safety data under review |
| Octocrylene | Mainly UVB protection and formula stabilization | Permitted under specified conditions; additional safety data under review |
| Octisalate | UVB protection | Permitted under specified conditions; additional safety data under review |
| Homosalate | UVB protection | Permitted under specified conditions; additional safety data under review |
| Bemotrizinol | Broad UVA and UVB protection | Added to the monograph in June 2026, subject to specified conditions and temporary exclusivity |
GRASE means Generally Recognized as Safe and Effective.
The FDA continues reviewing sunscreen ingredients as new safety information becomes available.
Two important updates occurred in 2026:
- June 2026: The FDA added bemotrizinol to the sunscreen monograph.
- September 2026: The FDA finalized the removal of PABA and trolamine salicylate from ingredients permitted under the monograph.
These changes are explained in the FDA’s official sunscreen regulatory updates.
Does an ingredient being reviewed mean it’s unsafe? Not necessarily. Some ingredients remain permitted under existing conditions while the FDA evaluates additional safety data.
Our advice: Review every active ingredient against current US requirements before approving your formula.
This is especially important if you’re adapting an existing sunscreen for a different market.
3. What SPF and Broad-Spectrum Tests Does the FDA Require?
You can’t label a sunscreen SPF50 simply because the formula contains a certain amount of UV filters.
The finished product needs appropriate testing.
SPF Testing and Accuracy
SPF measures protection against sunburn-causing UV radiation, mainly UVB.
If you’re developing SPF50 sunscreen, you need test results supporting that rating.
TY Cosmetic’s product documentation includes human SPF testing conducted by independent laboratories.
Actual Sunscreen SPF Testing Results
| Sunscreen Product | Labeled SPF | Reported Test Results | Testing Institution |
| Anti-Wrinkle, Brightening & Sun Protection Lotion | SPF50 | Measured SPF56 | Guangdong Weipu Testing Technology |
| Children’s Gentle Sunscreen Lotion | SPF26 | SPF26 | Guangdong Fangtu Testing |
| Snow Skin Charm Whitening Sunscreen Spray | SPF50+ before water exposure | SPF38 after water exposure | Testing details not supplied |
The Anti-Wrinkle, Brightening & Sun Protection Lotion reportedly achieved SPF56 against its SPF50 label.
The supporting documentation identifies report number GT03292023367722.
Why is this useful? It shows the value of testing the actual product instead of estimating SPF from the ingredients alone.
However, testing reports prepared for other markets still need to be reviewed against FDA methods before being used to support US labeling.
What About Broad-Spectrum Protection?
SPF isn’t the whole story.
Sunscreen also needs to address UVA protection if the brand wants to make a Broad Spectrum claim.
Here’s the difference:
- UVB: Mainly causes sunburn.
- UVA: Contributes to skin aging and damage.
- Broad Spectrum: Indicates the product passed the FDA’s required test for the claim.
Our technical documentation describes sunscreen formulas covering the 280–400 nm UV range.
It also includes the following UVA protection factor results.
| Product | Measured PFA | Reported Rating |
| Anti-Wrinkle, Brightening & Sun Protection Lotion | 14 | PA++++ claimed in source; rating needs verification |
| Children’s Gentle Sunscreen Lotion | 8 | PA+++ |
PFA values help evaluate UVA protection, but international PA ratings do not replace FDA broad-spectrum testing.
For Broad Spectrum SPF15 or higher sunscreens, the FDA permits an additional claim about reducing skin cancer and early skin aging risks when the sunscreen is used as directed with other sun protection measures.
The takeaway: Before approving your sunscreen label, ask for both the SPF report and the appropriate broad-spectrum test results.
4. How Should Sunscreen Be Labeled for the US Market?
Your sunscreen might perform well in testing, but an incorrect label can still cause compliance problems.
The FDA requires specific information on OTC sunscreen packaging.
Essential Sunscreen Label Information
| Label Element | What to Include |
| SPF Rating | Tested SPF value |
| Broad Spectrum | Claim supported by the required test |
| Active Ingredients | Names and concentrations of UV filters |
| Uses | Applicable FDA-permitted uses |
| Warnings | Required safety statements |
| Directions | How and when to apply |
| Water Resistance | Tested 40- or 80-minute duration, if applicable |
| Drug Facts | Required ingredient, use, warning, direction, and other information |
Want to check the rules yourself? The FDA’s labeling and effectiveness testing guide explains the required information and test procedures.
One common mistake is copying a label designed for another country.
Our product documentation includes two useful labeling examples.
Sample A: Anti-Wrinkle Shield Sunscreen Lotion SPF50 PA++++
This draft uses an FDA OTC-style label format.
It includes:
- Active ingredient information
- Application directions
- Required warnings
- Water-resistance information
It’s a useful reference during packaging development, but the final US label still needs a regulatory review.
Sample B: Radiant Bright Sun Lotion SPF50 PA+++
This foreign-trade packaging includes:
- SPF50 and PA+++ markings
- Broad Spectrum wording
- 50 ml net content
- Formula code GW250716-02#B
These details are useful for international packaging, but they don’t automatically make the label US-compliant.
How Often Should Sunscreen Be Reapplied?
FDA sunscreen directions generally include:
- Apply liberally before sun exposure, commonly 15 minutes beforehand.
- Reapply at least every two hours.
- For water-resistant products, reapply after the labeled 40 or 80 minutes of swimming or sweating.
- Reapply immediately after towel drying.
- Use water-resistant sunscreen when swimming or sweating.
Avoid claims such as “waterproof,” “sweatproof,” or “all-day protection without reapplication.”
Even water-resistant sunscreen needs regular reapplication.
Our recommendation? Review the final label before printing thousands of bottles or tubes. Fixing a design file is much easier than correcting finished packaging.
5. What Safety and Stability Testing Should Sunscreen Undergo?
SPF testing shows how well sunscreen protects against UV radiation.
But what happens when the product is exposed to heat? What if someone has sensitive skin?
These questions matter too.
Human Skin Compatibility Testing
Patch testing helps evaluate possible skin reactions under specific study conditions.
Our product documentation includes several human skin compatibility tests.
| Sunscreen Product | Participants | Reported Results |
| Anti-Wrinkle, Brightening & Sun Protection Lotion SPF50 | 20 people | 0 adverse reactions |
| Gentle Refreshing Sunscreen Lotion SPF50 | 30 people | 0 adverse reactions |
| Children’s Gentle Sunscreen Lotion SPF26 | 31 sensitive-skin participants | 0 adverse reactions during a 14-day test |
These results provide useful evidence about the tested products.
However, zero reactions in a small study don’t mean that every person will have the same experience.
For children’s sunscreen, sensitive-skin testing is especially useful during development. It should still be considered alongside the full product safety assessment.
What About Sunscreen Stability?
Sunscreen should maintain its quality during storage, shipping, and normal use.
Here are the main stability checks.
| Stability Test | What It Checks |
| Temperature Stability | Separation, thickening, and changes under heat |
| Light Stability | Formula changes caused by UV or other light exposure |
| Physical Stability | Crystallization, precipitation, and texture consistency |
| Packaging Compatibility | Reactions between the formula and its container |
| Shelf-Life Testing | Whether product quality remains acceptable over time |
Our formulation research includes approaches designed to reduce UV filter crystallization and improve sunscreen film stability.
We also have Antera 3D color-change data from separate foundation products tested at room temperature, 45°C, and under UV exposure.
The tests measured color changes at baseline, two, four, and six hours. Reported ΔE values were approximately 1.2–1.3, which the source describes as slight visual changes.
These results illustrate a testing approach, but they are not sunscreen-specific stability results.
For your sunscreen brand, request testing reports for the actual finished formula and packaging.
6. How Does Water Resistance Affect Sunscreen Performance?
Planning to develop sunscreen for swimming, running, or outdoor sports?
Then water resistance should be part of your product testing plan.
The FDA permits 40-minute and 80-minute water-resistance claims when supported by standardized testing.
Sunscreen Water-Resistance Categories
| Water Resistance | Suitable Activities | What to Verify |
| 40 Minutes | Recreational swimming, running, and beach activities | Standardized 40-minute testing |
| 80 Minutes | Longer swimming sessions and outdoor activities | Standardized 80-minute testing |
| No Water-Resistance Claim | Ordinary daily activities | Appropriate labeling without water-resistance claims |
Our sunscreen portfolio includes formulations developed for different outdoor conditions.
For example, the Whitening, Barrier-Protecting & Soothing Shake-Up Sunscreen Lotion SPF50+ PA++++ is positioned for demanding outdoor use, with an 80-minute water-resistance claim in its technical materials.
Other formulas target everyday outdoor activities, including products described as offering 40-minute resistance.
These claims still need the required finished-product evidence before appearing on US packaging.
How Does TENGYU-AGEL Technology Work?
Our TENGYU-AGEL formulation technology uses a structured sunscreen film designed to improve water resistance and UV filter distribution.
Instead of relying only on filters dispersed in liquid oil droplets, the system is designed to hold sunscreen ingredients within a structured network.
According to our technical materials, the approach aims to:
- Improve sunscreen film retention during water exposure.
- Reduce unwanted crystallization and precipitation.
- Support lightweight, even application.
The technology documentation describes the filters as being held within a hexagonal lattice-like structure.
It also reports a water-repellent surface with a contact angle greater than 90 degrees, compared with less than 90 degrees for the conventional emulsion used in the comparison.
7. Why Do Sunscreen Texture and Makeup Compatibility Matter?
Strong UV protection matters, but customers also want sunscreen that feels comfortable.
Does it leave a white cast? Feel greasy? Cause foundation to pill?
These details can affect how often people use the product.
Common Sunscreen Texture Problems
| Problem | What to Improve |
| White Cast | UV filter selection and dispersion |
| Pilling | Film-forming system and skincare compatibility |
| Greasy Finish | Oil-phase balance and formula texture |
| Slow Film Formation | Film-forming ingredients and application properties |
| Makeup Separation | Compatibility with foundation and primer |
Our sunscreen formulations include several products developed for daily use and makeup layering.
Yaobai Anti-Wrinkle Essence Sunscreen Lotion SPF50 PA++++
This oil-in-water formula is designed to feel lightweight, spread easily, and work under makeup without noticeable pilling.
Brightening Anti-Wrinkle Shield Sunscreen Lotion SPF50 PA++++
This product uses our TENGYU-AGEL formulation approach, with a lightweight finish and a film designed to adhere closely to the skin.
Foreign-Trade Brightening Sunscreen Lotion SPF50 PA+++
Its product materials describe film formation in approximately 30 seconds and compatibility with foundation.
These are manufacturer-reported product characteristics. Finished-product trials are still important before confirming performance.
What Do Consumers Look for in Sunscreen?
Our source materials include consumer preference data showing what buyers value.
| Consumer Priority | Reported Percentage |
| Gentle formula and safe ingredients | 45.86% |
| Sufficient sun protection | 43.35% |
| Refreshing, non-sticky feel | 40.85% |
| Cost-effectiveness | 36.03% |
| Sunscreen technology and ingredients | 29.29% |
| Easy application and cleaning | 28.32% |
| Brand reputation | 24.28% |
| Makeup compatibility and no pilling | 22.93% |
| Additional skincare benefits | 14.45% |
The same source reports a 16.16% year-on-year increase in consumer interest in lightweight, breathable sunscreen textures.
The survey date and methodology were not provided, so these figures should be treated as indicative rather than representative of the entire US market.
What does this mean for your brand?
Don’t test sunscreen only by itself. Try it with moisturizer, primer, and foundation to see how it performs in a normal skincare routine.
8. How Can TY Cosmetic Support Sunscreen Brand Development?
Developing sunscreen for the US market involves more than choosing an SPF rating.
You need the right ingredients, testing, manufacturing controls, and documentation.
TY Cosmetic provides OEM/ODM and private-label sunscreen development services, covering different formulas, textures, and product formats.
Our development work includes daily facial sunscreen, children’s products, outdoor protection, and water-resistant formulations.
Sunscreen Products You Can Develop
| Sunscreen Type | Development Options | Target Market |
| Daily Sunscreen Lotion | Lightweight texture and makeup-friendly finish | Everyday skincare |
| High-SPF Sunscreen | SPF50-focused formulas and performance testing | Daily and outdoor protection |
| Children’s Sunscreen | Mineral-based formulations and sensitive-skin development | Family skincare |
| Sunscreen Spray | Fine mist and quick film formation | Outdoor and convenient use |
| Water-Resistant Sunscreen | Formulations developed for 40- or 80-minute testing targets | Sports and outdoor activities |
| Sunscreen Stick or Paste | Portable, high-adherence formulas | Targeted outdoor protection |
Not every formulation or product format is automatically eligible for the US OTC market. Each needs an appropriate regulatory review.
Testing and Manufacturing Support
Our technical documents identify several third-party laboratories.
| Testing Organization | Reported Testing Activities |
| Guangdong Weipu Testing Technology | Human SPF testing and skin patch testing |
| Guangdong Fangtu Testing | Children’s SPF and sensitive-skin testing |
| SGS | Confocal Raman spectroscopy assessments |
Selected TENGYU-AGEL formulations have also undergone reported SGS confocal Raman spectroscopy assessments over eight hours.
These assessments were intended to examine sunscreen ingredient distribution within the skin.
However, the findings should not be described as proof of zero systemic absorption or guaranteed safety without reviewing the complete reports.
Our product materials also report a formulation approach intended to reduce sunscreen agent usage by 20% while improving protection efficiency by 20%.
These technology claims require formula-specific supporting evidence before promotional use.
Depending on your project, our development support can include:
- Custom sunscreen formulation and texture development.
- Product sampling and performance evaluation.
- Third-party SPF and UVA testing coordination.
- Skin compatibility and stability testing support.
- Water-resistance evaluation.
- Packaging design and market-specific label preparation.
- Technical documentation for regulatory review.
Our company materials also reference ISO 22716, Halal, and amfori BSCI certifications or audits. Brands should confirm their current validity and scope during supplier qualification.
In our experience, discussing testing requirements before designing packaging makes a project much easier to manage.
A clear plan helps avoid unnecessary reformulation and labeling changes later.
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Conclusion
FDA sunscreen compliance starts with choosing the right ingredients, but proper testing and labeling are just as important.
Before launching, check your SPF results, broad-spectrum testing, safety data, water-resistance claims, manufacturing standards, and packaging. A reliable manufacturer should help you understand which documents your product needs.
At TY Cosmetic, we support sunscreen brands with formulation development, product testing coordination, and customized packaging options.
If you’re planning your own sunscreen line, contact our team to discuss your formula, target market, and compliance requirements before production.
