FDA.reportPublic FDA data

OS-01 FACE SPF BS SPF 30 TINTED DEEP

Product NDC
84451-005
11-digit product format
844510005
Labeler code
84451
Product ID
84451-005_3581efdc-41fa-a450-e063-6294a90a4e56
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
2025-05-12
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 SPF 30 TINTED DEEP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3581f578-e19e-9ace-e063-6294a90acc34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84451-005-01OS-01 FACE SPF BS SPF 30 TINTED DEEP40 g in 1 TUBECREAM401
84451-005-02OS-01 FACE SPF BS SPF 30 TINTED DEEP1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84451-005OS-01 FACE SPF BS SPF 30 TINTED DEEP (ZINC OXIDE) CREAM [ONESKIN INC.]1Current NDC, 2 package rows20250521_3581f578-e19e-9ace-e063-6294a90acc34.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 16 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair LightZINC OXIDEREJUVA MINERALS INC2abccc86-01d4-e45c-e063-6294a90a7f8b2026-07-02WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
application number: M020
Sunscreen SPF 50AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf5e2a412-e891-411d-85da-89f38cd61a9b2026-07-02WarningsExact identifier
application number: M020
Bath and Body Works SPF Bronze KissAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.5606c57b-7fdb-4317-e063-6294a90a996c2026-07-02WarningsExact identifier
application number: M020
Evereden Kids Mineral Sunscreen SPF 30ZINC OXIDEEden Brands Incbba219a4-de83-76fd-e053-2995a90a2d692026-07-01WarningsExact identifier
application number: M020
Kids Mineral Face Cream SPF20ZINC OXIDEEden Brands Incfbfccb0c-e459-3282-e053-6394a90ad95d2026-07-01WarningsExact identifier
application number: M020
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50The Beach Roosterc2e57236-f184-4fa8-8fd5-c44cbf2300582026-07-01WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.557477a2-def8-740b-e063-6294a90ad2872026-06-30WarningsExact identifier
application number: M020
HealthyDerm tallow mineral sunscreen SPF50ZINC OXIDE 25%VIRENTIA LLC557b0b1f-8cd9-735a-e063-6294a90ad60e2026-06-30WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
application number: M020
Christian Dior Invisible UV Stick Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior8e3840b2-b404-474f-aff7-dec3a64a70a42026-06-29WarningsExact identifier
application number: M020
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
application number: M020
Sun Bum Coconut Lip 30 Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC20d942fa-93de-45a8-e063-6294a90a2b492026-06-29WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDETHE AVON COMPANY54f7c1d1-acdb-fd25-e063-6294a90a81732026-06-29WarningsExact identifier
application number: M020
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.55364026-c55a-b370-e063-6294a90ae0d12026-06-27WarningsExact identifier
application number: M020
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
application number: M020
ORLASKIN HYDRATING SUNSCREEN SPF 50OCTOCRYLENE ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE AVOBENZONEGuangzhou Yapheon Health Industry Co., Ltd.552b4c87-4621-d5a7-e063-6294a90a042e2026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Waikiki Beach CoconutAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c30de8a-4d29-bbac-e063-6294a90a84d92026-06-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84451-005-018445100050140 g in 1 TUBE40 gHistorical
84451-005-02844510005021 TUBE in 1 CARTON (84451-005-02) / 40 g in 1 TUBE (84451-005-01) 1 tube2025-05-12NoNoCurrent