FDA.reportPublic FDA data

Application 021501

Type
NDA
Sponsor
LOREAL USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAPITAL SOLEIL 15AVOBENZONE; ECAMSULE; OCTOCRYLENECREAM;TOPICAL2%;3%;10%YesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021501-001CAPITAL SOLEIL 15AVOBENZONE; ECAMSULE; OCTOCRYLENE2%;3%;10%CREAM / TOPICALRLD, RS2006-10-02

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021501-001CAPITAL SOLEIL 152%;3%;10%CREAM / TOPICALRLD, RS2006-10-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021501-001CAPITAL SOLEIL 152%;3%;10%CREAM / TOPICALRLD, RS2006-10-02cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021501-001CAPITAL SOLEIL 152%;3%;10%CREAM / TOPICALRLD, RS2006-10-02a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21698ORIG2009-05-27
27938SUPPL2007-06-07
15608SUPPL2007-06-07
27937SUPPL2007-05-01
37079SUPPL2007-04-25
27936ORIG2006-10-05