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 146 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Safe Sea SPF sport 65	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	0ed3242b-ac35-4d98-a777-1e44bb32a467	2025-12-08	Warnings	Exact identifier application number: M020
Safe Sea SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	46641a33-d658-4ef0-9b7a-062adc401dde	2025-12-08	Warnings	Exact identifier application number: M020
Skin Filter Glow SPF	ZINC OXIDE	MALORIE MILES	36485f44-a6bd-9529-e063-6294a90af7a4	2025-12-08		Exact identifier application number: M020
Skin Filter Matte SPF	TITANIUM DIOXIDE, ZINC OXIDE	MALORIE MILES	3647f983-9e75-8955-e063-6294a90af162	2025-12-08		Exact identifier application number: M020
Body-Screen	ZINC OXIDE	MALORIE MILES	36499be5-d680-92bf-e063-6394a90a89db	2025-12-08		Exact identifier application number: M020
Skin Filter Matte SPF	TITANIUM DIOXIDE, ZINC OXIDE	MALORIE MILES	3649f758-e31b-3c6a-e063-6294a90a5c36	2025-12-08		Exact identifier application number: M020
Body-Screen	ZINC OXIDE	MALORIE MILES	364ae392-480a-14ea-e063-6394a90a3883	2025-12-08		Exact identifier application number: M020
Personalized Moisturizer SPF 30	ZINC OXIDE 10.00%	Proven Skincare	d3cf8f81-d6ae-4570-ad86-43415e973e13	2025-12-08	Warnings	Exact identifier application number: M020
GLOW SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2f9d087c-b2b3-5654-e063-6294a90a94e5	2025-12-08	Warnings	Exact identifier application number: M020
MATTE SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2faee7ef-fc0c-6d01-e063-6294a90a6d68	2025-12-08	Warnings	Exact identifier application number: M020
GLOW SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2faf530d-5574-b702-e063-6294a90ad6fd	2025-12-08	Warnings	Exact identifier application number: M020
MATTE SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2fb00db0-4c37-56c6-e063-6294a90a8aff	2025-12-08	Warnings	Exact identifier application number: M020
Matte Shield SPF	TITANIUM DIOXIDE, ZINC OXIDE	ACNE SOLUTIONS NYC INC	3bb582ec-71e7-4ad8-e063-6394a90a94d4	2025-12-08	Warnings	Exact identifier application number: M020
SPF 101 Lightly Tinted	ZINC OXIDE	The Acne Lab LLC	334afdc8-1e12-d787-e063-6294a90aed7c	2025-12-08		Exact identifier application number: M020
SPF 101 Non-Tinted	ZINC OXIDE	The Acne Lab LLC	334bf8ea-2485-84e8-e063-6294a90aefa6	2025-12-08		Exact identifier application number: M020
SPF 101 Lightly Tinted	ZINC OXIDE	The Acne Lab LLC	334d694a-f9e4-ae86-e063-6394a90abfe1	2025-12-08		Exact identifier application number: M020
SPF 101 Non-Tinted	ZINC OXIDE	The Acne Lab LLC	334e32a4-c3a5-e37d-e063-6294a90ad6cf	2025-12-08		Exact identifier application number: M020
Mineral Based Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3245561d-a90c-7bf0-e063-6394a90ab3b6	2025-12-08		Exact identifier application number: M020
Mineral Based Sunscreen Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3245c1f7-2c1b-b6ad-e063-6394a90aaee6	2025-12-08		Exact identifier application number: M020
Mineral Based Facial Sunscreen	ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3e8981ed-5847-7009-e063-6394a90a49a1	2025-12-08	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