A Rinse-Off Claim on a Leave-On Product
A brand plans a body lotion marketed as 'apply generously and leave on'. The fragrance concentrate was originally developed and assessed for a shower gel in the rinse-off category, where a particular restricted material is permitted at a higher level. The lotion uses the same concentrate at 8% loading in the finished product. The regulatory team notices the marketing copy says 'rinse-off formula' in one place and 'leave-on body lotion' in another. The perfumer argues that because the product is used in the shower, it should be treated as rinse-off. The safety assessor must decide the correct category before the launch artwork is signed off.
1. Which category should apply, and why does the marketing wording not determine it?
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The correct category is leave-on, because the product is a body lotion intended to remain on the skin. Category assignment follows the actual use and exposure pattern, not the marketing phrase. A product used in the shower but left on the skin is leave-on for exposure purposes.
The phrase 'rinse-off formula' in the copy is therefore both a compliance risk and a consumer-information problem: it misdescribes use and could be read as an attempt to obtain a more permissive limit. The assessor should require the copy to be corrected to describe leave-on use and should assess the product against the leave-on limit.
2. How should the assessor handle the fact that the concentrate was previously assessed for rinse-off use?
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The prior assessment is not transferable. The assessor must re-evaluate the concentrate at 8% loading against the leave-on category limits. If the restricted material's leave-on maximum is lower than its rinse-off maximum, the finished-product concentration may now exceed the leave-on limit even though it complied in the shower gel.
The assessor should calculate the finished-product concentration, compare it with the leave-on limit, and if it exceeds, require reformulation or a lower loading. The prior rinse-off assessment can be retained as history but must not be cited as the basis for the lotion. This is a classic trap: reusing an assessment across categories without re-checking the limit.
3. What should the assessor require before artwork sign-off?
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Require: (1) corrected marketing copy that consistently describes leave-on use; (2) a category determination recorded in the safety file; (3) a fresh calculation of the restricted material at 8% loading against the leave-on limit; (4) if non-compliant, a reformulation or loading change with a new calculation; (5) confirmation that no other restricted materials in the concentrate were assessed only under rinse-off assumptions. Only when the file shows a leave-on assessment and consistent copy should artwork be approved.