Sourcing sunscreen sprays for the US market requires careful attention to FDA labeling requirements and the specific usage warnings mandated for over-the-counter (OTC) products. Failure to meet these standards can lead to costly relabeling, shipment holds, or brand reputation issues. This guide outlines the critical elements buyers should watch when developing, sourcing, or importing sunscreen sprays.
Key Labeling Elements for Sunscreen Sprays
- Drug Facts Panel – The FDA requires a standardized format including active ingredients, purpose, uses, warnings, directions, and inactive ingredients.
- SPF Value Claim – Must be supported by valid SPF testing results; false SPF claims risk enforcement action.
- Water Resistance Statement – Can only be included if substantiated by standardized water resistance testing.
- Active Ingredient Declaration – Precisely matched to OTC sunscreen monograph-adopted names.
- Lot Code & Expiration Date – Ensures traceability and confirms stability testing has validated the product shelf life.
Mandatory Usage Warnings
The FDA imposes specific warning statements for spray-format sunscreens to address inhalation and flammability concerns.
- Flammability: “Keep away from heat, sparks, open flame, and temperatures above 120°F.”
- Inhalation: “Do not spray directly into face; spray on hands then apply to face.”
- General Safety: “Avoid breathing spray mist” and “Use only as directed.”
- Children: “Keep out of reach of children” and usage guidance for children under 6 months (“Ask a doctor”).
Common Buyer Pitfalls
- Assuming sunscreen gel or lotion labeling rules automatically apply to sprays—spray formats have extra inhalation and flammability warnings.
- Omitting the exact mandated wording—paraphrasing can fail FDA label review.
- Skipping compatibility checks between propellants and packaging—may result in leaks or altered spray pattern.
- Neglecting revalidation of water resistance when changing formula or propellant.
Label Verification Table
| Element |
Evidence to Request |
Reason |
| SPF Claim |
SPF test report from ISO or FDA-recognized lab |
Proves label accuracy and legal compliance |
| Water Resistance |
Water resistance test results & protocol |
Allows inclusion of “Water Resistant” statement |
| Flammability Warning |
Label artwork with mandated warning text |
Ensures compliance for spray formats |
| Inhalation Warning |
FDA OTC sunscreen monograph excerpt |
Guarantees correct phrasing |
Best Practices for Buyers
- Request a full label proof from your manufacturer before approving production.
- Cross-check all warning statements with the latest FDA OTC monograph requirements.
- Ensure the Drug Facts panel formatting follows FDA guidelines exactly; avoid creative design changes that break compliance.
- Lock formulations before running SPF or water resistance testing—the label must reflect tested formula.
- Ask for mock-ups showing full wrap labels, including space for lot codes and expiration date.
FAQ
- Do I need FDA approval before selling sunscreen spray?
No premarket approval is required for compliant OTC sunscreen products, but your label and claims must follow the FDA sunscreen monograph and regulations.
- Can I change the warning wording to match brand tone?
No—mandated warnings must remain exactly as written in regulation for legal compliance.
- What if my sunscreen has multiple SPF strengths?
Each strength requires its own validated test data and separate Drug Facts panel reflecting the correct values.
- Is testing different for sprays vs lotions?
SPF and water resistance methods are similar, but sprays require extra safety testing for flammability and inhalation considerations.
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Hi, I'm Alex Zong, hope you like this blog post.
With more than 20 years of experience in OEM/ODM/Private Label Cosmetics, I'd love to share valuable knowledge related to cosmetics & skincare products from a top-tier Chinese supplier's perspective.
