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What to organize for each cosmetic product or SKU
FDA does not prescribe a universal 'per-SKU folder.' But a consistent product-level structure can make label and safety records easier to review, update, and retrieve.
Last reviewed: July 11, 2026
FDA says
FDA MoCRA overview ↗What FDA says about safety substantiation
FDA states that a responsible person must ensure and maintain records supporting adequate safety substantiation for cosmetic products. FDA also says that neither the law nor FDA regulations require a specific test for every individual cosmetic product or ingredient.
Relevant support can vary with the product and formulation. Scientific adequacy is a qualified-review question; a file's presence in an app does not establish that the evidence is sufficient.
Organizational suggestion
Anchor the record to a stable product identity
Use the Shopify product as an index, then record enough context to distinguish similar items and older versions. This helps prevent a document for one formula, shade, or package from being mistaken for another.
- Shopify product ID and product name.
- SKU, handle, or internal item code used by your team.
- Formula, shade, or packaging version when it changes the record set.
- Active, archived, or discontinued status.
- An internal owner and most recent review date.
Organizational suggestion
Preserve the label as a versioned record
Keep the current label copy with the product and retain older versions with dates rather than overwriting them. Record which version was in market during a particular period. That history is especially useful when investigating a complaint or assembling supporting information.
A label copy stored in MoCRA Ops Kit is an internal record. The app does not evaluate whether the label meets FDA or other labeling requirements.
Organizational suggestion
Index the evidence your reviewer actually relies on
Create an index rather than a universal required-document list. Depending on the product and your qualified review, possible supporting material might include supplier information, test reports, published data, formulation analyses, or records concerning similar formulations.
Do not mark an item 'complete' simply because a generic SDS, COA, stability report, or other file exists. Record what the file covers, its date, its version, and who decided it supports the product's safety review.
Organizational suggestion
Make the next action visible
A useful product view answers three operational questions: Is the current label attached? Are the chosen safety records indexed? Is anything expired or due for internal review? Link each gap directly to an upload or replacement action, then generate a product pack to confirm the record is retrievable.
Official sources
Related guides
Organize the records behind the workflow
Link product labels, safety documentation, adverse-event case files, and structured exports to your Shopify catalog.