Lip Clear Lysine Plus Coldstick

Product NDC: 70084-210
11-digit product format: 700840210
Labeler code: 70084
Product ID: 70084-210_419d7780-3a98-f9d0-e063-6394a90ad7f3
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate and Oxybenzone
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: Quantum, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1997-01-06
Substance: OCTINOXATE; OXYBENZONE
Active strength: 70; 50 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 24 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
2025-08-27 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	70084-210-01	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	70084-210-01	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	70084-210-01	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	70084-210-01	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	70084-210-01	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	70084-210-01	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	70084-210-01	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	70084-210-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70084-210-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70084-210-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70084-210-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	70084-210-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

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: Lip Clear Lysine Plus Coldstick
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	70 mg/g
OXYBENZONE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
95OOS7VE0Y	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
66f84e56-4a5d-4b71-8bd3-79961e7bf4fe	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	Lip Clear ® Lysine + ® Coldstick
2025-01-30	Lip Clear ® Lysine + ® Coldstick
2023-02-09	Lip Clear ® Lysine + ® Coldstick
2023-02-09	Lip Clear ® Lysine + ® Coldstick
2021-01-29	Lip Clear ® Lysine + ® Coldstick
2021-01-29	Lip Clear ® Lysine + ® Coldstick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70084-210-01	Lip Clear Lysine Plus Coldstick	5 g in 1 CYLINDER	LIPSTICK	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70084-210	LIP CLEAR LYSINE PLUS COLDSTICK (OCTINOXATE AND OXYBENZONE) LIPSTICK [QUANTUM, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20230211_66f84e56-4a5d-4b71-8bd3-79961e7bf4fe.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 209 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perfecting BB Beauty Balm Natural Tint SPF 30	ZINC OXIDE	Andalou naturals	16ca3790-9973-4a04-a43c-e0f7b384f147	2025-06-11	Warnings	Exact identifier application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR	AVOBENZONE, HOMOSALATE, OCTISALATE	PERENNEBELL Co., Ltd.	3690af2b-fe22-3a9a-e063-6294a90a709d	2025-06-10	Warnings	Exact identifier application number: M020
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEP	Pacifica Beauty, LLC	373901f7-0e32-0f32-e063-6394a90abe25	2025-06-10	Warnings	Exact identifier application number: M020
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TAN	Pacifica Beauty, LLC	37397b96-ef14-9098-e063-6294a90aafc9	2025-06-10	Warnings	Exact identifier application number: M020
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHT	Pacifica Beauty, LLC	373aba7c-2ae1-8726-e063-6294a90ae3d8	2025-06-10	Warnings	Exact identifier application number: M020
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUM	Pacifica Beauty, LLC	373c29b9-2f75-9777-e063-6394a90a68a6	2025-06-10	Warnings	Exact identifier application number: M020
Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30	AVOBENZONE, OCTISALATE, AND HOMOSALATE	MDSolarSciences	374395ea-ab91-de70-e063-6394a90aec56	2025-06-10	Warnings	Exact identifier application number: M020
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30	ZINC OXIDE	Andalou naturals	aa689e82-6512-46d8-aec9-269f9348d3f8	2025-06-09	Warnings	Exact identifier application number: M020
ALLIES OF SKIN The One SPF-50 Invisible Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	ALLIES GROUP PTE. LTD.	36e1c61c-33ab-4a5d-853d-119c29632b08	2025-06-09	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTION S	TITANIUM DIOXIDE AND ZINC OXIDE	Shiseido Americas Corporation	b2fae1ba-67fe-48ef-b31f-62db34349961	2025-06-09	Warnings	Exact identifier application number: M020
Olay Super Cream with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	372819f1-0813-2cd5-e063-6294a90ac5bf	2025-06-09	Warnings	Exact identifier application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-Clear	AVOBENZONE, HOMOSALATE, OCTISALATE	e.l.f. Cosmetics, Inc.	3806e2f2-ffd1-6d69-e063-6394a90acb44	2025-06-09	Warnings	Exact identifier application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-Getaway	AVOBENZONE, HOMOSALATE, OCTISALATE	e.l.f. Cosmetics, Inc.	3808613f-88d6-6c1a-e063-6294a90a5bb2	2025-06-09	Warnings	Exact identifier application number: M020
1000 Roses Daily Shade Facial SPF 18	OCTISALATE, OCTOCRYLENE, AND AVOBENZONE	Andalou naturals	0923e090-6834-4373-80fe-21f00b8c1c17	2025-06-09	Warnings	Exact identifier application number: M020
dAlba Vegan Fresh Sun Cushion	ZINC OXIDE, HOMOSALATE, OCTOCRYLENE	ADMTMAX LLC	20afcbab-a2f4-7965-e063-6294a90a83d1	2025-06-08	Warnings	Exact identifier application number: M020
dAlba Vegan Mild Sunscreen	ZINC OXIDE	ADMTMAX LLC	20ab5698-cd9f-0821-e063-6394a90a60d7	2025-06-08	Warnings	Exact identifier application number: M020
dAlba Vegan Fresh Sun Stick	HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE	ADMTMAX LLC	20ae82ae-bc8f-89d1-e063-6394a90afff2	2025-06-08	Warnings	Exact identifier application number: M020
dAlba Vegan Essence Sunscreen	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE	ADMTMAX LLC	1ccfa213-2f83-ad50-e063-6294a90a38bf	2025-06-08	Warnings	Exact identifier application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Medium	ZINC OXIDE	Pacifica Beauty, LLC	36ec6c9d-f7dc-0419-e063-6294a90a55e6	2025-06-06	Warnings	Exact identifier application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/Fair	ZINC OXIDE	Pacifica Beauty, LLC	36ed9101-249a-922c-e063-6394a90a2608	2025-06-06	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70084-210-01	70084021001	5 g in 1 CYLINDER (70084-210-01)	5 g	1997-01-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lip Clear ® Lysine + ® Coldstick	Quantum, Inc. \| Sun Deep Inc.	2025-10-20	HUMAN OTC DRUG LABEL	4