Drugs@FDA: FDA-Approved Drugs
Company: LOREAL USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ANTHELIOS 40 | AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE | 2%;3%;10%;5% | CREAM;TOPICAL | Over-the-counter | None | Yes | Yes |
ANTHELIOS 40 | AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE | 2%;3%;10%;5% | CREAM;TOPICAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/31/2008 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
Review Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022009s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022009_avobenzone_ecamsule_octocrylene_titanium_dioxide_cream_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022009s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/21/2014 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/09/2010 | SUPPL-4 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022009s004ltr.pdf |
10/29/2009 | SUPPL-2 | Efficacy-Manufacturing Change With Clinical Data |
Label is not available on this site. |
||
10/21/2008 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022009s001ltr.pdf |
ANTHELIOS 40
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;TOPICAL; 2%;3%;10%;5%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ANTHELIOS 40 | AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE | 2%;3%;10%;5% | CREAM;TOPICAL | Over-the-counter | Yes | 022009 | LOREAL USA |
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CREAM;TOPICAL; 2%;3%;10%;5%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ANTHELIOS 40 | AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE | 2%;3%;10%;5% | CREAM;TOPICAL | Over-the-counter | Yes | 022009 | LOREAL USA |