Home Applications 021502 Application 021502
Type NDA
Sponsor LOREAL USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ANTHELIOS SX AVOBENZONE; ECAMSULE; OCTOCRYLENE CREAM;TOPICAL 2%;2%;10% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021502-001 ANTHELIOS SX AVOBENZONE; ECAMSULE; OCTOCRYLENE 2%;2%;10% CREAM / TOPICAL RLD, RS 2006-07-21
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-09-29 23:25 UTC 2022-09 N021502-001 ANTHELIOS SX 2%;2%;10% CREAM / TOPICAL RLD, RS 2006-07-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021502-001 ANTHELIOS SX 2%;2%;10% CREAM / TOPICAL RLD, RS 2006-07-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021502-001 ANTHELIOS SX 2%;2%;10% CREAM / TOPICAL RLD, RS 2006-07-21 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49967-017 La Roche Posay Laboratoire Dermatologique Anthelios SX Daily Moisturizing Sunscreen Broad Spectrum SPF 15 Avobenzone, Ecamsule and Octocrylene L'Oreal USA Products Inc NDA Current 49967-017 La Roche Posay Laboratoire Dermatologique Anthelios SX Daily Moisturizing Sunscreen Broad Spectrum SPF 15 Avobenzone, Ecamsule and Octocrylene L'Oreal USA Products Inc NDA Current 49967-017 La Roche Posay Laboratoire Dermatologique Anthelios SX Daily Moisturizing Sunscreen Broad Spectrum SPF 15 Avobenzone, Ecamsule and Octocrylene L'Oreal USA Products Inc NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 37081 SUPPL 2007-03-15 5558 SUPPL 2007-03-15 27940 SUPPL 2007-01-25 15610 SUPPL 2007-01-17 27939 SUPPL 2006-12-28 5557 SUPPL 2006-12-28 5556 SUPPL 2006-12-28 21699 SUPPL 2006-12-26 15609 SUPPL 2006-12-26 37080 SUPPL 2006-12-14 42195 ORIG 2006-09-15 5555 ORIG 2006-07-25