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 173 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e l f Camo Semi Matte CC SPF 30 Rich 660 N	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	853100ea-a9dc-43eb-9715-125b543d2be0	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 400 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	e4f2b579-4886-4e20-a527-c033e9d60bf5	2025-10-31	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 460 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	49255019-fa24-4667-b527-ef7189a51f12	2025-10-31	Warnings	Exact identifier application number: M020
SEKKISEI HERBAL UV DEFENSE gel	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	KOS America, Inc.	cb0faa3a-68f8-49c5-8c28-3338b1b27cd8	2025-10-31	Warnings	Exact identifier application number: M020
Perricone MD Hypoallergenic Clean Correction Ultra-Lightweight Calming SPF 35 Veil	ZINC OXIDE	THG Beauty USA LLC	2c749a52-adaa-2609-e063-6294a90a8fc2	2025-10-30	Warnings	Exact identifier application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	4260e410-d2d5-71b4-e063-6294a90a05b8	2025-10-30	Warnings	Exact identifier application number: M020
Clove Hill Tinted Mineral Sunscreen SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	eb2ff5a7-384f-4379-b149-47c1c8c2291d	2025-10-30	Warnings	Exact identifier application number: M020
Tinted Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	a37db64d-8b79-40f4-843f-f38949c5b9d2	2025-10-30	Warnings	Exact identifier application number: M020
WEIGHTLESS PROTECTION SPF 30	OCTINOXATE, ZINC OXIDE, OCTISALATE	Botanical Science Technologies	de9a97b8-6633-4d71-e053-2995a90a5e8f	2025-10-30	Warnings	Exact identifier application number: M020
Avinichi Noni Sol Shield Cream SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	9e534e32-efea-4dcf-adc1-18de3847ac04	2025-10-30	Warnings	Exact identifier application number: M020
MOOYAM Dark Skin Sunscreen	SUNSCREEN	Guangdong Bisutang Biotechnology Co., LTD	4246e9f1-1c51-d888-e063-6394a90abda0	2025-10-29	Warnings	Exact identifier application number: M020
Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	THG Beauty USA LLC	1cd10158-c346-60c9-e063-6294a90a54bd	2025-10-29	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	0fb5a140-838d-3226-e063-6294a90a8860	2025-10-29	Warnings	Exact identifier application number: M020
non-tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Clove Hill LLC	311b270f-b9e2-2374-e063-6294a90af581	2025-10-29	Warnings	Exact identifier application number: M020
Hello Bello Kids Mineral Sunscreen	ZINC OXIDE TITANIUM OXIDE	Hello Bello	3e7a3e8e-eacf-0a30-e063-6294a90ab7ec	2025-10-29	Warnings	Exact identifier application number: M020
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25	TITANIUM DIOXIDE	THG Beauty USA LLC	23f4cf41-0eed-2df3-e063-6294a90ad402	2025-10-28	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	0fb58346-a638-3091-e063-6394a90ad754	2025-10-28	Warnings	Exact identifier application number: M020
TIBENA EVERYTHING MULTI CUSHION SPF50	HOMOSALATE, TITANIUM DIOXIDE	KONAD CO LTD	421eda8f-62b2-30fb-e063-6394a90a4947	2025-10-27	Warnings	Exact identifier application number: M020
Bondi Sands Broad Spectrum SPF 60 Sunny Drops Face Serum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	289efa6d-427b-8be6-e063-6394a90adae3	2025-10-27	Warnings	Exact identifier application number: M020
goPure Sunscreen	ZINC OXIDE	Natural Lifestyle Brands, LLC dba GoPure beauty	a74ec20b-8436-4030-820c-01fd88134f40	2025-10-27	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