PRODUCT RECALL INVESTIGATION REPORT

Report Number: PRI-2026-045
Product: Spray Sunscreen SPF50+ PA+++
Batch Number: SSA-2026-07
Production Date: July 5, 2026
Units Distributed: 18,240
Units Recalled: 18,240
Recall Initiated: August 25, 2026
Report Date: September 4, 2026
Prepared By: Quality & Regulatory Affairs Department
Classification: Class I – Serious Adverse Health Risk

1. Executive Summary

This report documents the investigation into the SPF test failure of Spray Sunscreen SPF50+ PA+++, Batch SSA-2026-07. The batch was manufactured at [Redacted] in Guangzhou, China, and distributed to 7 countries: USA, Canada, UK, Australia, Singapore, Japan, and South Korea.

Problem Summary:

• Labeled SPF: 50+

• Laboratory tested SPF: 26.8 (average of 10 samples)

• Reduction from labeled SPF: 46%

• PA rating test: PA+++ (from PA+++)

• No change in PA rating. UVB protection only affected.

Recall Scope:

• 18,240 units distributed

• 18,240 units recalled

• Estimated recall cost: $276,000 (product replacement + logistics + customer notification)

• Estimated brand impact: Not quantified.

Root Cause: Incorrect valve selection in the aerosol can. The valve selected for Batch SSA-2026-07 had higher product output per spray. The higher output reduced the film thickness on the skin. Film thickness affects SPF. Thinner film = lower SPF.

Recommendation: The supplier's valve selection process must be revised. All future batches must be tested with the production valve before batch release.

2. Product Description

3. Quality Issue Identification

3.1 Initial Detection

On August 15, 2026, the Quality Assurance laboratory conducted routine post-market SPF testing on retained samples from Batch SSA-2026-07.

Test Parameters:

Observation: The average SPF was 26.8, below the minimum acceptable of 50. The product failed to meet the labeled claim.

3.2 Confirmation Testing

Retained samples from the same batch were tested by an independent laboratory (SGS, Shanghai) using the same ISO methods.

The independent test confirmed the internal results. The batch was failing the SPF claim.

4. Investigation Scope

The investigation examined the following areas:

1. Raw material testing records

2. Production process and valve calibration

3. Filling and packaging records

4. Storage and transport conditions

5. Comparison with previous successful batches

6. Supplier valve specifications

7. Laboratory testing procedures

5. Findings

5.1 Raw Materials

All raw materials used in Batch SSA-2026-07 were tested and passed. Active ingredient concentrations were within specification.

Conclusion: Raw materials are not the cause of the failure.

5.2 Production Process

The production process was reviewed. The batch was manufactured using the standard process.

Observation: Valve identification records for Batch SSA-2026-07 show a different valve part number than the previous three batches.

Finding: The valve was changed for Batch SSA-2026-07. The new valve (V-200B) has a different orifice size.

5.3 Valve Specification Comparison

The V-200B valve has a 50% larger orifice. It delivers 52% more product per spray. The additional product per spray, combined with the lower pressure, creates a thicker droplet size and different film formation.

5.4 Film Thickness Correlation

The relationship between film thickness and SPF was measured in the laboratory. The lab applied the product to artificial skin at varying thicknesses and measured SPF.

The V-200B valve produces a thinner film (1.6 microns vs. 2.0 microns). Thinner film = lower SPF.

5.5 Supplier Change Notification

The contract manufacturer changed the valve supplier from Supplier X to Supplier Y. Supplier Y's valve design was similar but not identical. The contract manufacturer did not test the new valve with the existing formulation before using it on Batch SSA-2026-07.

Root Cause: The contract manufacturer changed the valve supplier without conducting a compatibility test with the product formulation.

6. Root Cause Summary

7. Corrective Action Plan

8. Financial Impact Summary

9. Regulatory Implications

The product was recalled in all 7 markets. Regulatory notifications were filed in each market. No adverse health events were reported. The product failed the SPF claim but did not cause harm.

Regulatory Status:

10. Conclusion

The failure of Batch SSA-2026-07 was caused by the contract manufacturer's change of valve supplier without the brand's knowledge and without compatibility testing. The new valve produced a thinner film on the skin, resulting in lower SPF.

Actions Taken:

1. Batch SSA-2026-07 was recalled from all markets.

2. The contract manufacturer has been notified and has accepted responsibility.

3. The contract manufacturer has committed to notifying the brand of any valve or component changes in the future.

Actions Pending:

1. Valve compatibility testing must be completed before the next batch is produced.

2. Film thickness testing must be added to the batch release criteria.

Recommendation:
The brand should consider adding a "supplier change notification" clause to the manufacturing agreement with the contract manufacturer. This clause would require the contract manufacturer to notify the brand of any changes to components, materials, or suppliers that could affect product performance.

Report Prepared By:

Dr. Linda Wei, Regulatory Affairs Manager
September 4, 2026

Reviewed By:

Michael Chen, Quality Director
September 5, 2026

Approved By:

Sarah Lee, VP of Product Development
September 6, 2026

This report is confidential and intended for internal use only. Distribution to third parties is prohibited without the written consent of the Regulatory Affairs Department.

SPF testing of Batch SSA-2026-07 showed 26.8 SPF vs. labeled 50+. 18,000 units distributed in 7 countries. Full investig

SPF50+ sunscreen spray tested at 26.8 SPF. 18,000 units recalled across 7 countries. Investigation identified root cause. Full report.

Jangan direproduksi tanpa izin：Blog-Pulviso » Product Recall Investigation Report: Spray Sunscreen SPF50+ – Batch SSA-2026-07