FDA.reportPublic FDA data

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
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
2205ec0e-ac3f-299f-e063-6294a90a2174Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84451-003-01OS-01 Face SPF BS SPF30 Untinted40 g in 1 TUBECREAM401
84451-003-02OS-01 Face SPF BS SPF30 Untinted1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84451-003OS-01 FACE SPF BS SPF30 UNTINTED (ZINC OXIDE) CREAM [ONESKIN INC.]1Current NDC, 2 package rows20240915_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 236 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc50182-30f5-b77e-e063-6394a90a63552025-01-15WarningsExact identifier
application number: M020
MEDIFORDEAR CICA CALMING SUNSCREENHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, AVOBENZONEYoungwon Costech Co.,ltd.2bc94923-b221-5159-e063-6394a90ab8ff2025-01-15WarningsExact identifier
application number: M020
Meaningful Beauty Cindy Crawford Anti-Aging Day Creme with Environmental Protection Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONEMeaningful Beauty, LLC6423e1c7-85cd-46f8-8fc9-a7284e3577d12025-01-15WarningsExact identifier
application number: M020
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESpectrum Aesthetics Laser Training LLC026b9b30-ef08-bf2e-e063-6394a90a54a62025-01-14WarningsExact identifier
application number: M020
Daily Sunscreen Broad Spectrum SPF 30 UVA UVBMINERAL SUNSCREEN SPF 30IHerb, LLC2d8101ef-96a3-1463-e063-6294a90add4d2025-01-14WarningsExact identifier
application number: M020
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d85b0a1-3705-2829-e063-6394a90a0ed72025-01-13WarningsExact identifier
application number: M020
Attitude mineral sunscreen orange blossom SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0b85ea68-6113-4e92-a10a-39d13099d12d2025-01-13WarningsExact identifier
application number: M020
Skinfuse Shield SPF 30ZINC OXIDEOwen Biosciences, Inc.02d46d44-2476-4f96-9c72-783c392317de2025-01-13Exact identifier
application number: M020
Chem Free SPF 30ZINC OXIDEOwen Biosciences, Inc.7e5930fe-eb0f-4a21-8065-8831dd5b351c2025-01-13WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 ShellZINC OXIDEEVER FAME PTE. LTD.2b9b5a73-858e-78dd-e063-6394a90ad0822025-01-13WarningsExact identifier
application number: M020
Tula Skincare protect and go dewy glow sunscreen stick broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company2b9acb63-b32c-336c-e063-6394a90a4a9c2025-01-13WarningsExact identifier
application number: M020
Brush and Go All Skin typesTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd9ee5b3c2-4369-4c4b-ab55-b52661b821882025-01-13WarningsExact identifier
application number: M020
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Inc5c4219ac-d65f-43a5-8ec4-8732b9b344cf2025-01-13WarningsExact identifier
application number: M020
Brush and Go Oily Problematic SkinTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdb4295453-f193-4bed-be5b-efcd917721072025-01-13WarningsExact identifier
application number: M020
Zealios SPF LipGuardOCTISALATE AND AVOBENZONEPersonal Best Products Inc. dba Zealios3a07822b-a7c9-40af-a8f7-bea591c7a49b2025-01-13WarningsExact identifier
application number: M020
SPF-30 BBZINC OXIDEZION HEALTH66d33d8c-8900-4698-98fe-0dedafe674d82025-01-13WarningsExact identifier
application number: M020
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Incb2addf27-9139-48b4-85e6-618f4b5311cc2025-01-13WarningsExact identifier
application number: M020
Skin Apeel Ageless Defense SPF 40 Broad SpectrumZINC OXIDESkin Apeel, Inc.c3bbe779-b012-4f19-8b90-2c7a4dd886172025-01-13WarningsExact identifier
application number: M020
UNCOMPLIKATED MAKEUP SETTING SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEKATE SOMERVILLE SKINCARE LLC1a33cb41-440a-41cb-9832-24255bfa2b7c2025-01-12WarningsExact identifier
application number: M020
ALLSWELL MINERAL SUNSCREEN SPF 30ZINC OXIDEStream2Sea, LLC03bee988-d6e3-4290-a926-9c5366649cba2025-01-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84451-003-018445100030140 g in 1 TUBE40 gHistorical
84451-003-02844510003021 TUBE in 1 CARTON (84451-003-02) / 40 g in 1 TUBE (84451-003-01) 1 tube2023-08-15NoNoCurrent