OS-01 Lip SPF BS SPF15

Product NDC: 84451-004
11-digit product format: 844510004
Labeler code: 84451
Product ID: 84451-004_351d69f9-5ae2-1dec-e063-6294a90ad7a1
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: ONESKIN INC.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-05-07
Substance: ZINC OXIDE
Active strength: 5.5 g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: OS-01 Lip SPF BS SPF15
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	5.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
351d55f6-fcd9-1d47-e063-6294a90a2cf0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84451-004-01	OS-01 Lip SPF BS SPF15	12 g in 1 TUBE	CREAM	12		1
84451-004-02	OS-01 Lip SPF BS SPF15	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84451-004	OS-01 LIP SPF BS SPF15 (ZINC OXIDE) CREAM [ONESKIN INC.]	1	Current NDC, 2 package rows	20250515_351d55f6-fcd9-1d47-e063-6294a90a2cf0.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 214 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lip Love Moisture Balm SPF30 - Watermelon	ZINC OXIDE	Koco Life LLC	3491fb2a-d55f-1736-e063-6294a90a594a	2025-05-07	Warnings	Exact identifier application number: M020
Abib Heartleaf mild sunscreen Relief tube	ZINC OXIDE	FOURCOMPANY CO., LTD.	34965587-c9b7-4066-e063-6394a90ab424	2025-05-07	Warnings	Exact identifier application number: M020
CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Laboratoires Clarins	157cb8ca-1a36-41fb-be9e-b157b146dc4d	2025-05-06	Warnings	Exact identifier application number: M020
Mango Bay SPF 50 Sport	AVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENE	Inspec Solutions	e25e4f76-8311-491b-e053-2a95a90a4fc8	2025-05-06	Warnings	Exact identifier application number: M020
Mango Bay SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Inspec Solutions LLC.	e260b901-5918-48df-e053-2a95a90a68c3	2025-05-06	Warnings	Exact identifier application number: M020
Mango Bay SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Inspec Solutions LLC.	e25cf8e4-93cd-f5f6-e053-2995a90a4545	2025-05-06	Warnings	Exact identifier application number: M020
Mango Bay SPF 30 Gallon	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Inspec Solutions LLC.	e260c1bc-8b79-abc7-e053-2a95a90ae4d2	2025-05-06	Warnings	Exact identifier application number: M020
Lip Love Moisture Balm SPF30 - Pink Strawberry	ZINC OXIDE	Koco Life LLC	347e665f-cb59-ab04-e063-6394a90ad0a6	2025-05-06	Warnings	Exact identifier application number: M020
Saucd Toasted Golden Tanning SPF 15 Caramel	AVOBENZONE, OCTISALATE, HOMOSALATE	SAUCD GENERAL TRADING COMPANY	e10d41cd-e03e-401c-9024-263350b3ec2a	2025-05-05	Warnings	Exact identifier application number: M020
Visor Clear Body Mist Hydrating Sunscreen SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	VISOR SKINCARE LLC	b2d7639c-cbfb-4127-8ee4-7355e0d021e1	2025-05-05	Warnings	Exact identifier application number: M020
Jacket Ultimate Performance Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BALSHI MD DERMACEUTICALS	d4d82c41-01da-40af-a22c-d4d57af7a2f2	2025-05-05	Warnings	Exact identifier application number: M020
All Good Mineral Sport Sunscreen Butter Stick SPF 50	ZINC OXIDE	Elemental Herbs, Inc.	114c6ac8-b133-cd16-e063-6294a90ac4f9	2025-05-05	Warnings	Exact identifier application number: M020
All Good kids mineral sunscreen butter stick SPF 50	ZINC OXIDE	Elemental Herbs, Inc.	feb94fd7-6727-6fb1-e053-6394a90a2af1	2025-05-05	Warnings	Exact identifier application number: M020
Vivier Sheer SPF 30 Mineral Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Vivier Pharma, Inc.	e12e3bcb-4c3d-41be-8e2b-12a817c8b367	2025-05-05	Warnings	Exact identifier application number: M020
EVERY DAY MINERAL SUN SCREEN SPF 45	ZINC OXIDE	Stream2Sea, LLC	7ec4954f-7d60-405b-8bff-cb602fc44a4e	2025-05-04	Warnings	Exact identifier application number: M020
ABIB QUICK AND AIRY SUNSTICK DUO SET	HOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONE	FOURCOMPANY CO., LTD.	34292261-4d05-e07d-e063-6294a90a4741	2025-05-02	Warnings	Exact identifier application number: M020
LION POSE UNGHOSTED TINTED MINERAL SPF 42 UVA UVB SUNSCREEN	ZINC OXIDE	Lion Pose Inc.	341b90b4-82ae-e8c6-e063-6394a90aeefd	2025-05-01	Warnings	Exact identifier application number: M020
LAPCOS DAILY SUNSCREEN SPF 50	SUNSCREEN	LAP USA, INC.	337c3528-5739-6b4a-e063-6294a90a3cb4	2025-05-01	Warnings	Exact identifier application number: M020
Hiya Kids SPF 40 Mineral Sunscren	ZINC OXIDE	Hiya Health Products LLC	33119ec6-2cd8-8978-e063-6394a90afd97	2025-05-01	Warnings	Exact identifier application number: M020
EltaMD UV AOX Elements	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc	d01756c0-1f82-4e08-b956-8000ecaddfd1	2025-05-01	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
84451-004-01	84451000401	12 g in 1 TUBE	12 g				Historical
84451-004-02	84451000402	1 TUBE in 1 CARTON (84451-004-02) / 12 g in 1 TUBE (84451-004-01)	1 tube	2025-05-07	No	No	Current