FDA acceptance marks Alma’s first U.S. OTC drug listing, expanding the company beyond devices into regulated skincare innovation
CHICAGO, Feb. 5, 2026 /PRNewswire/ — Alma, a global leader in energy-based medical and aesthetic technologies, together with dermatological science brand Universkin, today announced a key regulatory milestone with the successful acceptance by the U.S. Food and Drug Administration (FDA) of the Product Listing SPL for Universkin by Alma, Daily Mineral Serum SPF 50 Broad Spectrum.
Universkin by Alma, Daily Mineral Serum SPF 50 establishes a new category in dermatological care, a high-performance, mineral serum engineered specifically for immediate post-procedure use following laser, RF, IPL, microneedling, and chemical peels, strengthening physician loyalty and enhancing treatment outcomes.
At the core of the product is Universkin’s proprietary DUAL-SHIELD 50 Technology, an advanced zinc-oxide dispersion architecture developed specifically for post-procedure skin. The system pairs a concentration of zinc oxide (24%) with an oil-continuous gel-emulsion structure that delivers broad-spectrum UV protection while actively managing residual heat in treated skin.
Unlike conventional mineral sunscreens that can trap heat and increase discomfort after laser or RF procedures, DUAL-SHIELD 50 incorporates micro-dispersed aqueous phases that function as thermal sinks, helping dissipate heat while maintaining photostability, transparency, and skin tolerance. This dual-layer approach enables the product to deliver an enhanced post-procedure comfort, positioning it as a dermatological recovery solution rather than a conventional cosmetic sunscreen.
As the global aesthetic procedures market continues to expand and regulatory scrutiny of chemical UV filters intensifies, demand for mineral-only, dermatologist-validated photoprotection is accelerating. Daily Mineral Serum SPF 50 positions Alma and Universkin at the convergence of medical aesthetics, dermatology, and premium skincare, a high-growth segment driven by physician recommendation and patient trust.
The FDA product listing acceptance represents the final regulatory step ahead of broad U.S. market visibility and supports near-term commercialization while reinforcing Alma’s long-term strategy of building integrated treatment ecosystems that extend beyond devices into outcome-driven skin recovery solutions.
About Alma
Alma is a global leader in medical aesthetic solutions, with over 25 years of innovation. The company empowers practitioners to deliver safe, effective, and transformative treatments through state-of-the-art, clinically proven solutions spanning energy-based lasers, skin analysis, and advanced skincare. Alma’s multiple award-winning products have set new benchmarks in the medical aesthetics industry, combining clinical excellence with groundbreaking innovation. For more information, visit the company’s website: almalasers.com
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