OS-01 Face SPF BS SPF30 Untinted

Product NDC: 84451-003
11-digit product format: 844510003
Labeler code: 84451
Product ID: 84451-003_22060b23-45e8-c29d-e063-6294a90a4be6
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: 2023-08-15
Substance: ZINC OXIDE
Active strength: 17.5 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 Face SPF BS SPF30 Untinted
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	17.5 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
2205ec0e-ac3f-299f-e063-6294a90a2174	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84451-003-01	OS-01 Face SPF BS SPF30 Untinted	40 g in 1 TUBE	CREAM	40		1
84451-003-02	OS-01 Face SPF BS SPF30 Untinted	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
84451-003	OS-01 FACE SPF BS SPF30 UNTINTED (ZINC OXIDE) CREAM [ONESKIN INC.]	1	Current NDC, 2 package rows	20240915_2205ec0e-ac3f-299f-e063-6294a90a2174.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 345 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
H.E.B Solutions Sunscreen	COCONUT PINEAPPLE SCENTED SPF 50 STICK	H.E.B	29aef42c-f617-4c56-a166-8e1f0d6dbfd0	2021-07-09	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm Beige	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	58465981-e84c-4eaf-b7d5-fad1666f63fc	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Bamboo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	b2259b27-e1a5-482c-8916-356c1ee9774a	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Bronze	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	199dde64-1dd3-4eb6-baef-261c97162f79	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Creme	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	753c34f2-3cb8-4df7-9aeb-ea926fb0279a	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Dune	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	745dd675-86ee-4acc-8333-4870e0a57c75	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Latte	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	e66734e4-34e7-4674-bb98-bdca931a176d	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sand	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	bf78f7a7-93ca-425e-8571-175da6798e8e	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sepia	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	418cdd4a-23f7-4181-b734-5ab7456494a2	2021-06-29	Warnings	Exact identifier application number: M020
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Toffee	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	50138c51-f424-4b07-b3eb-c0d31d8ecf16	2021-06-29	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Cameo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	01a861b9-0ab6-4c4c-a407-428a64509a1c	2021-06-29	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Birch	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d5431d62-fded-4cdc-81a1-5b5e3eb92873	2021-06-29	Warnings	Exact identifier application number: M020
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	52c3378f-6b99-42fa-900e-8a693864c615	2021-06-29	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	FACE SPF 70 LOTION	H.E.B	73b49068-953b-496d-8ea9-404df7e79089	2021-01-19	Warnings	Exact identifier application number: M020
Think Every Day Face Sunscreen SPF 30	ZINC OXIDE	thinkOperations,LLC	afed91dd-8544-4b4b-e053-2995a90a2d16	2020-09-22	Warnings	Exact identifier application number: M020
THINKSPORT Kids sunscreen SPF 50	ZINC OXIDE	thinkOperations,LLC	8b5a147d-4126-4fc5-a73b-fd5a19ccfd3d	2020-09-08	Warnings	Exact identifier application number: M020
THINKBABY Baby Sunscreen SPF 50	ZINC OXIDE	thinkOperations,LLC	820317d2-1803-4949-bddf-09521a5d1750	2020-09-08	Warnings	Exact identifier application number: M020
THINKSPORT sunscreen SPF 50	ZINC OXIDE	thinkOperations,LLC	6b9b3ea2-65e5-4a51-a6e6-c79f89e5ccea	2020-08-03	Warnings	Exact identifier application number: M020
ESSENTIALS Face and Body Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Rodan & Fields	dfc44a01-e8fd-43fc-b3cd-5cac17e4a5a3	2020-04-02	Warnings	Exact identifier application number: M020
Thinksport Sunscreen SPF 18	ZINC OXIDE	thinkOperations,LLC	9cd5010c-0b23-2888-e053-2995a90adb72	2020-01-23	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
84451-003-01	84451000301	40 g in 1 TUBE	40 g				Historical
84451-003-02	84451000302	1 TUBE in 1 CARTON (84451-003-02) / 40 g in 1 TUBE (84451-003-01)	1 tube	2023-08-15	No	No	Current