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 83 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunscreen Lotion118mL	ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	46355437-4068-9d03-e063-6394a90ae52c	2026-01-09	Warnings	Exact identifier application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30	SUNCARE FACE SUNSCREEN SPF30	Aopline Biotechnology (Guangzhou) Co., Ltd.	47f26af6-4d02-3506-e063-6294a90a0fe6	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care Carrot	OCTINOXATE	Farmasi US LLC	67de9257-70f3-4444-a4a2-a8d7425fcc0e	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad Spectrum	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE	Farmasi US LLC	d9197dce-20a3-4d10-807c-ec84ab902165	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Lumi Radiance Brightening	OCTOCRYLENE, OCTINOXATE, AVOBENZONE	Farmasi US LLC	adf5621b-7cf0-53b3-e053-2a95a90a8058	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15	HOMOSALATE, OCTINOXATE	FARMASI US LLC	1dbd5e83-2248-4751-88d9-b446ccc3c61e	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body Sun	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE	Farmasi US LLC	27fdbd2b-60de-4906-a176-5c5198d9925b	2026-01-09	Warnings	Exact identifier application number: M020
Skin Metal Stealth	ZINC OXIDE	Skin Metal	47f5d7de-5d32-041a-e063-6394a90ab6f9	2026-01-09	Warnings	Exact identifier application number: M020
Salt and Blue Body Sunscreen SPF 30	ZINC OXIDE 20%	Salt + Blue LLC	47f764a0-e9ad-ef66-e063-6394a90a8de5	2026-01-09	Warnings	Exact identifier application number: M020
City Sunscreen serum Broad Spectrum SPF 30 Supergoop	HOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENE	Supergoop, LLC	61766f7b-512d-45b5-b652-e09975a3d3fc	2026-01-09	Warnings	Exact identifier application number: M020
Defense Refresh (Re)Setting Mist SPF 40	AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENE	Supergoop LLC	b95ad8e3-978b-b721-e053-2a95a90a1e54	2026-01-09	Warnings	Exact identifier application number: M020
Daily Dose Vitamin C and Broad Spectrum SPF 40 Serum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop LLC	aed0dd03-1695-a5a9-e053-2995a90acfdc	2026-01-09	Warnings	Exact identifier application number: M020
Hand Screen Broad Spectrum Sunscreen SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	972ebab9-3f2f-6716-e053-2a95a90a5c75	2026-01-09	Warnings	Exact identifier application number: M020
Glow Oil Broad Spectrum Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	972c68e7-b137-34c6-e053-2a95a90a77d6	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip Gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ee045b64-7a95-4378-8183-e6e556f3b184	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	967d0657-18fc-4e4a-b52d-442df43329f1	2026-01-09	Warnings	Exact identifier application number: M020
PLAY SPF 30 Lip Shield Coconut	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b0b8b850-bdfe-5563-e053-2995a90a51a7	2026-01-09	Warnings	Exact identifier application number: M020
Play SPF 30 Lip Shield Strawberry	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b0a49142-53c3-5b7a-e053-2995a90a581d	2026-01-09	Warnings	Exact identifier application number: M020
Glow Stick Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	61e543e3-9ace-6440-e053-2991aa0a9647	2026-01-09	Warnings	Exact identifier application number: M020
(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35	ZINC OXIDE	Supergoop, LLC	af5c9801-26ce-5c60-e053-2995a90ab457	2026-01-09	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