NDA 22009, held by Loreal USA. Avobenzone; Ecamsule; Octocrylene; Titanium Dioxide.
As of Nov 13, 2026, NDA 22009 (Anthelios 40), held by Loreal USA, was first approved by FDA on Mar 31, 2008, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 29, 2009 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 31, 2008 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Anthelios 402%;3%;10%;5% · cream;topical | Avobenzone; Ecamsule; Octocrylene; Titanium Dioxide | OTCReference drug |
| Anthelios 402%;3%;10%;5% · cream;topical | Avobenzone; Ecamsule; Octocrylene; Titanium Dioxide | OTCReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 21, 2014 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Apr 9, 2010 | Supplement 4Labeling | Approved | |
| Oct 29, 2009 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | None posted |
| Oct 21, 2008 | Supplement 1Labeling · Standard review | Approved | |
| Mar 31, 2008 | 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
