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 198 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ScarAid SPF	SILICONE STICK WITH SPF	Biodermis, LLC	3c19063a-cdde-1bbe-e063-6294a90aa8a2	2025-08-11	Warnings	Exact identifier application number: M020
Pro-Sil SPF	SILICONE STICK WITH SPF	Biodermis, LLC	3be06f82-935d-b1c2-e063-6294a90a953c	2025-08-11	Warnings	Exact identifier application number: M020
Curology Daily Moisturizing	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Curology, Inc	3c1967fc-bb89-2f7e-e063-6394a90a2512	2025-08-11	Warnings	Exact identifier application number: M020
ScarAid US SPF	SILICONE STICK WITH SPF	Biodermis, LLC	3c196fa4-1bd3-7a43-e063-6294a90a4fb7	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 23W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	96973dee-681b-4c5d-b31f-de05cd79fa18	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 24N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ecda3658-eca1-48c2-9eff-e22fd1ff70df	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c6f27df4-6de4-45e4-90cb-ea8b0d29dbd3	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	968abacd-8b99-4529-a627-2b56cdf99e1b	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	a9068dc0-bc48-498b-adc9-57ff810384af	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37f01f66-c604-4fc3-a263-2089db91283f	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	bca57893-bd2d-44ac-a503-2f11c3b62bf2	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37188b77-ab0b-4bea-b839-99e589600a2b	2025-08-11	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c89e45d6-2322-4913-a557-e1780a86fd63	2025-08-11	Warnings	Exact identifier application number: M020
Sun Bum Face 70 Premium Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c1ed89c-6d50-6400-e063-6294a90a1433	2025-08-11	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 15mL with Pink Algae SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	24e9ea4d-3073-c126-e063-6394a90a7c6e	2025-08-10	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM PEACH SHAKE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	d1c5b7a5-73f9-4df6-9469-ce42e4f33ae8	2025-08-08	Warnings	Exact identifier application number: M020
GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTE	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	96efeb92-a276-4ac9-b30a-11b4fa367263	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER PEACH SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	edeb2ee1-cc84-4254-80c1-6410cd77c422	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER STRAWBERRY SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	7abe936b-a4d5-457c-9cdd-761b201bb046	2025-08-08	Warnings	Exact identifier application number: M020
GR LIP BUTTER BLUEBERRY SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	e4eb80d8-e75c-4bb7-b3bc-9f05a0f23bab	2025-08-08	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