NDA 21501, held by Loreal USA. Avobenzone; Ecamsule; Octocrylene.
As of Nov 14, 2026, NDA 21501 (Capital Soleil 15), held by Loreal USA, was first approved by FDA on Oct 2, 2006, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Capital Soleil 152%;3%;10% · cream;topical | Avobenzone; Ecamsule; Octocrylene | OTCReference drug |
| Feb 21, 2014 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jun 5, 2007 | Supplement 3Labeling · Standard review | Approved | |
| Apr 24, 2007 | Supplement 1Labeling · Standard review | Approved | |
| Oct 2, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
