Structured Product Labeling (SPL)

Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven International (HL7) and adopted by the FDA as the required format for electronic submission of product information. In the cosmetics context, SPL XML is used for MoCRA facility registration and product listing submissions through the Electronic Submissions Gateway (ESG NextGen).

SPL documents encode product information in a structured, machine-readable XML format. For cosmetic product listings, the SPL includes the product name, category, responsible person information, facility where the product is manufactured, and the complete ingredient list using standardized nomenclature.

While brands can submit facility registrations and product listings through the FDA's web-based Cosmetics Direct portal (which generates SPL internally), the SPL/ESG pathway is preferred for bulk submissions, automated workflows, and integration with compliance management systems.

The FDA publishes SPL implementation guides specific to cosmetics submissions, along with XML schemas and validation rules. Third-party software including Cosmetica can generate compliant SPL XML automatically from product data and submit it programmatically through the ESG NextGen API.