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 170 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vertra Pearl White Face Stick SPF 50	PADIMATE O, TITANIUM DIOXIDE	Toshiki Pigment Co., ltd.	b7163861-7084-5adf-e053-2995a90ae199	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 8	OCTINOXATE AND OXYBENZONE	Tropical Seas, Inc.	b5fa2883-998f-2128-e053-2995a90a5c84	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 15	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b557c9c5-6ea8-1d59-e053-2995a90aff68	2025-11-04	Warnings	Exact identifier application number: M020
Vertra Ehukai Beige Face Stick SPF 38	TITANIUM DIOXIDE	Toshiki Pigment Co., ltd.	b71619c4-a8ef-1dda-e053-2995a90aba50	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 45	OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE	Tropical Seas, Inc.	b4cafdf1-44e1-10c0-e053-2995a90ab3dc	2025-11-04	Warnings	Exact identifier application number: M020
Reef Kids SPF 30 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	e226b07a-9f44-4b17-8f26-c86dcfa5dcda	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 50	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b4cc95f0-d684-5331-e053-2995a90a3295	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 20	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b55792e6-2ead-1fb1-e053-2995a90ac915	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 8	OCTINOXATE AND OXYBENZONE	Tropical Seas, Inc.	b5e68448-4131-1c6c-e053-2a95a90a014a	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 40	ZINC OXIDE AND TITANIUM DIOXIDE	Tropical Seas, Inc.	d204c38c-b5d1-3511-e053-2a95a90a9dc8	2025-11-04	Warnings	Exact identifier application number: M020
Expedition BackCountry SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e4e63c-3e51-0a78-e053-2a95a90abd87	2025-11-04	Warnings	Exact identifier application number: M020
Reef Babies SPF 50 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	8cd68b09-2578-4519-b00e-e83e0e440815	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e44be7-3a46-34e2-e053-2a95a90a9660	2025-11-04	Warnings	Exact identifier application number: M020
Reef Kids SPF 30 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	005a9e7c-e392-4b9a-911f-d7586f7ae94e	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b559d349-2ffd-492c-e053-2995a90aab06	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark Zinky SPF 36 Pink Beach	ZINC OXIDE	Tropical Seas, Inc.	d240e6c9-d053-9924-e053-2a95a90a855a	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 15	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e49c6f-477b-aafc-e053-2a95a90a982a	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b559e03b-f5d3-bd72-e053-2995a90a31ca	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30 Clear Zinc	ZINC OXIDE AND TITANIUM DIOXIDE	Tropical Seas, Inc.	d128269b-73fa-e5f3-e053-2995a90af1ed	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 50 Sport	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e40a7c-b49d-cfc3-e053-2995a90ac27e	2025-11-04	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