Replenix Lip Therapy homosalate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Replenix Lip Therapy homosalate
Generic name: HOMOSALATE
Manufacturer: Topiderm, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: b60dc004-d713-47bc-a6e9-ea4783aa7019
SPL ID: cda6e73e-8e21-48d6-bd98-282e4a06ff32
Version: 7
Effective date: 2023-02-02
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:47:53

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M020	openfda.application_number
brand name		Replenix Lip Therapy homosalate	openfda.brand_name
generic name		HOMOSALATE	openfda.generic_name
manufacturer name		Topiderm, Inc.	openfda.manufacturer_name
ndc	package	51326-102-04	openfda.package_ndc
ndc	product	51326-102	openfda.product_ndc
ndc11	package	51326010204	derived:openfda.package_ndc
spl id		cda6e73e-8e21-48d6-bd98-282e4a06ff32	id
spl set id		b60dc004-d713-47bc-a6e9-ea4783aa7019	set_id
unii		V06SV4M95S	openfda.unii
unii		G63QQF2NOX	openfda.unii
unii		4X49Y0596W	openfda.unii
unii		4Y5P7MUD51	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For lip application only. This product delivers a temporary tingling sensation to the lips. Only apply product inside the line of your lips. When using this product keep out of eyes, rinse with water to remove. Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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