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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021502
Company: LOREAL USA

Products on NDA 021502

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANTHELIOS SX	AVOBENZONE; ECAMSULE; OCTOCRYLENE	2%;2%;10%	CREAM;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021502

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/2006	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021502s000_AntheliosTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
08/27/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/14/2007	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021502s006ltr.pdf
01/12/2007	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s004_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021502s004ltr.pdf
12/13/2006	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502s003ltr.pdf
12/12/2006	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502s002ltr.pdf
12/14/2006	SUPPL-1	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021502s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021502s001lbl.pdf

Labels for NDA 021502

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/14/2007	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s006lbl.pdf
01/12/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021502s004_LBL.pdf
12/13/2006	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s003lbl.pdf
12/12/2006	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021502s002lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

ANTHELIOS SX

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%;2%;10%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ANTHELIOS SX	AVOBENZONE; ECAMSULE; OCTOCRYLENE	2%;2%;10%	CREAM;TOPICAL	Over-the-counter	Yes	021502	LOREAL USA

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