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 156 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OUHOE SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.42fcc9ed-083c-6582-e063-6394a90ae9e62025-11-27WarningsExact identifier
application number: M020
EELHOE Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305cb87e-450f-840a-e063-6294a90a883f2025-11-27WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.349a3d72-9969-855d-e063-6394a90a281c2025-11-27WarningsExact identifier
application number: M020
EELHOE Cica Cooling Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305c13af-0843-f478-e063-6394a90a42de2025-11-27WarningsExact identifier
application number: M020
EELHOE Quick Sun Stick Protection BarTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.3578c958-a457-402b-e063-6394a90a73422025-11-27WarningsExact identifier
application number: M020
EELHOE Matte Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.42cfa690-15fe-e5de-e063-6394a90a8e712025-11-27WarningsExact identifier
application number: M020
JAYSUING Moisturiser Sun StickTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.42c307d9-aaa9-30df-e063-6294a90aa1142025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE4494bea6-ab1f-aae6-e063-6394a90a184d2025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44853202-6873-0bc8-e063-6394a90a05f02025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE43f43c5a-2680-f549-e063-6394a90aade32025-11-27WarningsExact identifier
application number: M020
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Tropical cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44954d7c-2a78-3df4-e063-6294a90ab56f2025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Watermelon and CocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE449712ab-5c23-7d50-e063-6394a90ab7fe2025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44991f67-9160-ccce-e063-6394a90ada1f2025-11-27WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Sprayer SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE4499bcda-f0ba-878e-e063-6394a90a5fc02025-11-27WarningsExact identifier
application number: M020
EcoZinc Kids Natural Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED44615ae4-8206-122d-e063-6294a90a0b2c2025-11-27WarningsExact identifier
application number: M020
HANCHOBIT SunscreenTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.42fd5d3e-4e98-86d7-e063-6294a90a45c22025-11-27WarningsExact identifier
application number: M020
HANCHOBIT SunscreenTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.375b60f1-ad33-578a-e063-6294a90a1fc62025-11-27WarningsExact identifier
application number: M020
EcoZinc x DSO Welders 98 percent UVC Protection Sunscreen for WeldingZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386e35de-cd13-f430-e063-6394a90acc842025-11-27WarningsExact identifier
application number: M020
HANCHOBIT Matte Sun StickTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.375bacf7-9372-bff7-e063-6294a90ae67c2025-11-27WarningsExact 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