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 198 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	1dd9fe59-9e40-fd06-e063-6394a90a4ca2	2025-08-12	Warnings	Exact identifier application number: M020
Coola Anti-Aging Hand Cream Sunscreen	AVOBENZONE, OCTOCRYLENE, OCTISALATE	COOLA LLC	3c2fbf10-d68e-c601-e063-6294a90a09a3	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 15mL with Pink Algae SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	24ea340a-06cd-b085-e063-6394a90adff9	2025-08-12	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	15536331-fec5-4daa-824d-2e32d63e6452	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	1ddad045-7703-ea7e-e063-6394a90a2a5a	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 15mL SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	0cf45fbf-b257-f16a-e063-6294a90a8794	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 40mL SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	1ddb1f53-69dd-643a-e063-6394a90ad600	2025-08-12	Warnings	Exact identifier application number: M020
Earth Mama Lady Face Mineral Sunscreen - Medium/Dark Tint Broad Spectrum SPF 40	ZINC OXIDE	Earth Mama Angel Baby LLC	908c41fd-0496-4237-813b-1135e10ae0c5	2025-08-12	Warnings	Exact identifier application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40	ZINC OXIDE	Earth Mama Angel Baby, LLC	74475fba-4cdd-4b27-8ea4-646f4016580c	2025-08-12	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 25	ZINC OXIDE	Earth Mama Angel Baby, LLC	2aa44439-663a-400b-b432-e2dc5ac2a3d1	2025-08-12	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40	ZINC OXIDE	Earth Mama Angel Baby, LLC	afc88e77-a4a1-49ec-b021-bb468fd0ac68	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	31049b45-0f5e-58b6-e063-6394a90ae52c	2025-08-12	Warnings	Exact identifier application number: M020
Earth Mama Lady Face Mineral Sunscreen - Light/Medium Tint Broad Spectrum SPF 40	ZINC OXIDE	Earth Mama Angel Baby LLC	bd71a814-c0b4-428b-987e-72f7f55f998f	2025-08-12	Warnings	Exact identifier application number: M020
earth mama UBER-SENSITIVE MINERAL Sunscreen SPF 40	ZINC OXIDE	Earth Mama Angel Baby, LLC	e9a88a57-5733-489d-a459-dd74c04daff2	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	1ddae545-99db-144b-e063-6294a90adae5	2025-08-12	Warnings	Exact identifier application number: M020
Sun Bum Protecting Scalp and Hair Mist SPF 30 sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3aa05afb-c843-f38f-e063-6294a90a1cdf	2025-08-12	Warnings	Exact identifier application number: M020
Sun Bum High Performance Sunscreen Signature Clear 50	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	Sun Bum, LLC	390c6afd-e2be-414c-e063-6294a90ae119	2025-08-12	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Mosturizing Sunscreen 1 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c32d2c0-0dbe-42e3-e063-6294a90aa993	2025-08-12	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c342e57-cf85-b423-e063-6394a90a61b9	2025-08-12	Warnings	Exact identifier application number: M020
MATTE UNIVERSAL TINTED MOISTURIZER SPF46	ZINC OXIDE, OCTINOXATE	Drmtlgy, LLC	8e284afd-b90f-41d5-b334-e5cf4440b4d3	2025-08-12	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