Anthelios 40
Avobenzone; Ecamsule; Octocrylene; Titanium Dioxide
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Oct 29, 2009
16 yr 11 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE
Strength
2%;3%;10%;5%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 022009
Product number
002
Marketing status
Over-the-counter
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Other strengths in NDA 022009
Active-ingredient family
This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
View full Avobenzone; Ecamsule; Octocrylene; Titanium Dioxide familyListed patents
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Anthelios 40 — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Avobenzone; Ecamsule; Octocrylene; Titanium Dioxide active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
