La Roche-Posay Cicaplast Balm B5: the skin-protectant label question

The first record names Cosmetique Active Production as packager and NDC 69625-743. The second names L’Oréal USA Products Inc. with NDC 49967-744. Both were labeled as updated September 10, 2026 when reviewed, and each uses B5 wording in the named dimethicone preparation. They are distinct labeler records, rather than two independent clinical tests. Cosmetique label record L’Oréal label record

These identifiers make a question about an actual package more concrete. They do not establish that an unseen tube corresponds to either record or that a B5+ title in another market has the same formula. The prescription questions guide likewise keeps a supplied preparation separate from a product name or a familiar commercial family.

Both US labels state dimethicone 1% as the active ingredient and skin protectant as the purpose. Their uses concern temporarily protecting and relieving chafed, chapped or cracked skin and protection from drying wind or cold, among the listed label uses. Those are the uses attached to the actual drug-label record, not a claim that the preparation treats menopausal hormone changes. Active ingredient and purpose

The useful professional question is which labeled purpose is relevant to the concern and what the exact package says. This review does not diagnose a skin problem, prescribe a way to apply the product or determine that a particular person falls within the label’s intended use. A retail purchase route cannot answer those individual questions by itself.

The inactive list includes panthenol, madecassoside, glycerin, shea butter and numerous other components. It does not give a panthenol percentage. The 1% figure in these records is attached to active dimethicone, and it should not be reassigned to another ingredient or used to calculate a different strength. Inactive declaration Stated active strength

The active and inactive roles are useful when explaining what the label actually names. They do not describe every biological contribution an ingredient might have, provide an assay of a supplied tube or establish that a highlighted ingredient delivers a particular facial result. The pharmacist or clinician can clarify the preparation and the purpose without relying on an unverified percentage from a different product title.

The Cosmetique label lists 40 mL and 100 mL tubes, alongside smaller 3 mL and 1 mL package entries. The package table identifies record options; it does not prove which item a retailer currently supplies or what is present in a reader’s possession. No purchase or dispensed container was inspected. Recorded package descriptions

The separate NDC and labeler information should remain part of any clarification, rather than treating a shared B5 name as proof that every package is interchangeable. Other named-product discussions can be followed in the RoC review and the CeraVe review. Those links offer additional reading, not evidence that their preparations serve the same labeled purpose.

The label’s marketing information states OTC Monograph Drug and cites M016. FDA explains that some OTC drugs conform to a monograph, while the New Drug Application pathway involves a different approval process. A DailyMed listing or NDC therefore should not be presented as an individual NDA approval of this B5 preparation. Label marketing category FDA approval and monograph distinctions

FDA also describes Drug Facts labeling requirements for OTC drugs. Here the active ingredient and purpose come from an actual US drug label, so the review preserves that role instead of treating the preparation only as an appearance moisturizer. The regulatory explanation gives context; it does not independently validate efficacy, audit manufacturing or settle eligibility for an individual. FDA labeling explanation

The B5 label contains warnings that need to be understood in the context of the actual skin concern and preparation. They were read as part of the source context, but this article does not turn them into a routine, a screening tool or clearance for use. The exact label is the place to identify the question that needs a professional answer. B5 label warning section

FDA’s medication-list guidance supports communication about prescription and nonprescription medicines. Our medication-list conversation guide keeps the named preparation visible alongside other care without deciding whether a combination is suitable. Our separate discussion of facial estriol and menopause treatment also keeps a skin-protectant purpose from becoming a substitute for a hormone-treatment decision. FDA communication guidance

This review is bounded to the B5-named US label records. The available manufacturer product context did not establish how those records correspond to every B5+ name or formula. That uncertainty is preserved rather than supplying a version history or borrowing a percentage from another market. The named B5 product and its label-based role remain the supported starting point. Exact B5 product identity

FDA’s intended-use framework explains why a product category cannot be chosen solely from retail placement. AAD’s general moisture explanation likewise does not supply a firmness, wrinkle or hormone-related outcome for this drug label. The professional question can stay with the exact package, labeled purpose and desired observation, while leaving an unresolved B5+ comparison open. FDA intended-use context AAD general moisture context