Replenix Lip Therapy

Product NDC: 51326-102
11-digit product format: 513260102
Labeler code: 51326
Product ID: 51326-102_cda6e73e-8e21-48d6-bd98-282e4a06ff32
Type: HUMAN OTC DRUG
Nonproprietary name: homosalate
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: Topiderm, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-01-02
Substance: HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength: 150; 75; 50; 30 mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51326-102-04	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51326-102-04	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51326-102-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51326-102-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51326-102-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51326-102-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51326-102-04	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51326-102-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51326-102-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Replenix Lip Therapy
Brand name suffix: homosalate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	150 mg/g
OCTINOXATE	75 mg/g
OCTISALATE	50 mg/g
AVOBENZONE	30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b60dc004-d713-47bc-a6e9-ea4783aa7019	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51326-102-04	2025-01-30	C162847	48780-1	2cef2736-80c4-d83d-e063-dadaa90ab31f	REPLENIX ® Lip Therapy homosalate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51326-102-04	Replenix Lip Therapyhomosalate	4 g in 1 BOTTLE	LIPSTICK	4		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51326-102	REPLENIX LIP THERAPY HOMOSALATE (HOMOSALATE) LIPSTICK [TOPIDERM, INC.]	5	Current NDC, 1 package rows	20230209_b60dc004-d713-47bc-a6e9-ea4783aa7019.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 66 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN	HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE	Oracle Cosmetic Co., Ltd.	21424f78-f8d5-6a9b-e063-6294a90ab7dc	2026-02-02	Warnings	Exact identifier application number: M020
HAMPTON SUN SPF50 SUNSHIELD BODY GLOW	HOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%	S&C Hampton Sun LLC	26190992-9463-47ae-86a5-0dbc05be8773	2026-02-02	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE	Rite Aid Corporation	fe9146ec-b85d-43da-a391-377960f2c772	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M020
sheer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rite Aid Corporation	299a6690-9746-4410-a625-7636f0b4a754	2026-02-02	Warnings, Adverse reactions	Exact identifier application number: M020
Dr. C. Tuna Sun Stick SPF 50	AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE	Farmasi US LLC	49dc6040-b400-7f5b-e063-6394a90ac7d7	2026-02-02	Warnings	Exact identifier application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50	ZINC OXIDE	e.l.f. Cosmetics, Inc	535f798f-d21d-92b2-e063-6294a90a72c7	2026-02-02	Warnings	Exact identifier application number: M020
Sol de Janiero Rio Radiance SPF 50 Body	ZINC OXIDE	Cosmetic Solutions LLC	2d54727d-5dcc-4792-85e8-1a2f21fe9e3d	2026-02-02	Warnings	Exact identifier application number: M020
Sky and Sol Face and Body Sunscreen Spf 50	ZINC OXIDE	Delta Ecommerce LLC	47d9dc66-328f-4cab-e063-6394a90a279d	2026-02-01	Warnings	Exact identifier application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f cosmetics,Inc.	4b801bb3-8930-7e04-e063-6294a90adaa1	2026-02-01	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEAR	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	cedd7a3e-3334-437f-a283-482bcd0064ee	2026-01-30	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	bf16e8b5-b717-4255-a7da-9abe3d1ad8b4	2026-01-30	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rite Aid Corporation	372a8fba-b190-40fe-a1fc-fecf7f7afc35	2026-01-30	Warnings, Adverse reactions	Exact identifier application number: M020
ALOE UP MEDICATED LIP BALM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Aloe Care International, LLC	859b6d3f-b1ca-4966-8f0c-f9afa0d5864c	2026-01-30	Warnings	Exact identifier application number: M020
ALOE UP SPORT NATURAL BALM SPF-15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Aloe Care International, LLC	3de029ed-97f7-4cb3-a32e-d412bf3b5874	2026-01-30	Warnings	Exact identifier application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01	TITANIUM DIOXIDE, ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	49a77ad4-508c-9617-e063-6394a90a5623	2026-01-30	Warnings	Exact identifier application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetic Solutions LLC	d65ae1c9-dff5-4612-b8be-fa59bba03b81	2026-01-30	Warnings	Exact identifier application number: M020
Touch in SOL No Poreblem Airbrushed Primer	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	BONNE Co., Ltd	4685ff24-0bb0-3502-e063-6394a90abfee	2026-01-29	Warnings	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Aldi, Inc	c7650d20-7cb9-4861-8a30-cf4a9cd424e9	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Aldi, Inc	32c0613e-0f5a-47f5-b2f3-f32ae07cbc76	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M020
Vacation Original Coconut SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Vacation INC.	a9a0b558-b8e6-44ea-9b57-6938837a04fb	2026-01-29	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51326-102-04	51326010204	4 g in 1 BOTTLE (51326-102-04)	4 g	2022-01-02	No	No	Current