# K050158: Sinclair Seborrhea Emulsion

- Pathway: 510(k) (Traditional)
- Applicant: Sinclair Pharmaceuticals, Ltd.
- Decided: Oct 11, 2006 after 624 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961758 (1996). 3 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024367: Sinclair Wound and Skin Emulsion, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.

## Most influential descendants
- K111168: Precision Skin Emulsion (2011), 5 descendants of its own
- K123724: Dermiseb Cream (2013), 4 descendants of its own
- K120730: Loutrex Topical Cream (2012), 4 descendants of its own
- K121134: TL Triseb Cream (2012), 4 descendants of its own
- K152945: Alevicyn SG Antipruritic Gel (2015), 3 descendants of its own

## Indications for use
FOR TOPICAL DERMATOLOGICAL USE ONLY Description Rx Product: Under the supervision of a healthcare professional, Sinclair Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Sinclair Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process. Directions For Use (Rx and OTC): Apply Sinclair Skin Emulsion to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover Sinclair Skin Emulsion with a dressing of choice. Description OTC Product: Sinclair Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation and wounds.

Source page: https://510kreport.com/device/K050158
Methodology: https://510kreport.com/methodology