| K-number | K250890 |
| Device name | SBC1 Cream |
| Applicant | Sioxmed, LLC |
| Product code | FRO |
| Device class | Class U |
| Decision date | Jan 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
SBC1 Cream is a fragrance-free, non-sterile topical skin emulsion indicated for managing itching and dryness in atopic dermatitis and allergic contact dermatitis. It should not be used on breached, compromised skin, or open sores. The product promotes a moist environment and is provided by prescription only in 1 oz and 8 oz jar sizes.
SBC1 Cream has the same indications for use and similar formulation as the predicate device (SiOxC Cream). Both are water-based emulsions containing emollients, humectants, structural and stabilizing agents, pH adjusters, surfactants/emulsifiers, antioxidants, and preservatives including a proprietary amorphous hydrated silica. Both use phenoxyethanol as the preservative and are non-sterile, single-patient-use products available in identical jar sizes.
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23 (biocompatibility testing); USP <51> (preservative effectiveness); USP <61>/<62> (microbial testing for total plate count and yeast/mold).
SBC1 Cream is substantially equivalent to SiOxC Cream based on identical indications for use, matching technological characteristics and composition, identical preservative systems, and non-clinical performance testing demonstrating equivalent biocompatibility and preservative effectiveness with microbial control meeting specifications.
View the full FDA submission: accessdata.fda.gov