Anthelios 20

NDA 21471, held by Loreal USA. Avobenzone; Ecamsule; Octocrylene; Titanium Dioxide.

As of Nov 14, 2026, NDA 21471 (Anthelios 20), held by Loreal USA, was first approved by FDA on Oct 5, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 5, 2006
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 5, 2006	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Anthelios 202%;2%;10%;2% · cream;topical	Avobenzone; Ecamsule; Octocrylene; Titanium Dioxide	OTCReference drug

All 3 submissions, including labeling and manufacturing supplements


Feb 21, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 17, 2008	Supplement 4Labeling · Standard review	Approved	Letter
Oct 5, 2006	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21471
Drugs@FDA: Overview at FDA
Company: L'Oréal USA

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