Tinted Mineral Lip Sunscreen

Product NDC: 82746-212
11-digit product format: 827460212
Labeler code: 82746
Product ID: 82746-212_42663287-9c3d-f19a-e063-6394a90ac505
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: STICK
Route: TOPICAL
Labeler: Clove Hill LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-11-16
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 40; 55 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 16 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	82746-212-45	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	82746-212-45	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	82746-212-45	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	82746-212-45	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	82746-212-45	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	82746-212-45	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	82746-212-45	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	82746-212-45	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Tinted Mineral Lip Sunscreen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	40 mg/g
ZINC OXIDE	55 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	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
a37db64d-8b79-40f4-843f-f38949c5b9d2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82746-212-45	2025-01-30	C162847	48780-1	2cef2736-8bfd-d83d-e063-dadaa90ab31f	DRUG FACTS
82746-212-45	2025-01-30	C162847	48780-1	2cef2736-8bfd-d83d-e063-dadaa90ab31f	a37db64d-8b79-40f4-843f-f38949c5b9d2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82746-212-45	Tinted Mineral Lip Sunscreen	4.5 g in 1 TUBE	STICK	4.5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82746-212	TINTED MINERAL LIP SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [CLOVE HILL LLC]	2	Current NDC, 1 package rows	20231116_a37db64d-8b79-40f4-843f-f38949c5b9d2.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 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
(Re) Setting 100% mineral Powder Light Broad Spectrum SPF 35	ZINC OXIDE	Supergoop, LLC	aed5a7ef-5cf2-6738-e053-2a95a90aa7f7	2026-01-09	Warnings	Exact identifier application number: M020
Play Mineral Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	89088ac5-f1ee-1996-e053-2a95a90a8fdc	2026-01-09	Warnings	Exact identifier application number: M020
(RE) Setting 100% Mineral Powder Medium Broad Spectrum Sunscreen SPF 35	ZINC OXIDE	Supergoop, LLC	af4b0f17-43ec-a176-e053-2a95a90a7ac6	2026-01-09	Warnings	Exact identifier application number: M020
(Re) Setting 100% mineral Powder Deep Broad Spectrum SPF 35	ZINC OXIDE	Supergoop, LLC	af4cb85b-1275-2105-e053-2995a90a7e74	2026-01-09	Warnings	Exact identifier application number: M020
Play Lip Balm with Acai Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	9f5b54c7-a424-6917-e053-2a95a90ac627	2026-01-09	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82746-212-45	82746021245	4.5 g in 1 TUBE (82746-212-45)	4.5 g	2023-11-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tinted Mineral Lip Sunscreen	Clove Hill LLC \| Custom Analytics LLC \| Fragrance Manufacturing Inc. \| Fallien Cosmeceuticals Ltd.	2025-10-30	HUMAN OTC DRUG LABEL	4