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 237 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Baby Donna SHeer SPF Sunscreen StickZINC OXIDEStream2Sea, LLCa1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe2025-01-12WarningsExact identifier
application number: M020
SUN PROTECT LIP BALM SPF 30ZINC OXIDE AND TITANIUM DIOXIDEStream2Sea, LLC21386652-b952-48be-b077-1acecc7f0eb02025-01-12WarningsExact identifier
application number: M020
Equate Beauty Daily Moisturizer SPF-30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEWal-Mart Stores, Inc.00abd6d0-c467-4885-80fe-b062622147d72025-01-10WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b5aebed-49f6-7bb8-e063-6294a90a85212025-01-10WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Drops Face SerumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b5c69e4-2819-94ef-e063-6394a90a68e72025-01-10WarningsExact identifier
application number: M020
Dermaroller Anhydrous Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.04e82f1b-c893-4795-b7a9-0523e3ec75522025-01-10WarningsExact identifier
application number: M020
Skinfuse Shield SPF 30ZINC OXIDEOwen Biosciences, Inc.b8e4c11a-4b4f-4e36-a75e-0a73913113d52025-01-10WarningsExact identifier
application number: M020
Correct and Protect Serum Broad Spectrum SPF 45ZINC OXIDEMurad, LLC60c62108-6806-4722-a44b-f1c300d59c1e2025-01-10WarningsExact identifier
application number: M020
Multi Vitamin Clear Coat Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLCe023c874-c89d-4bd0-a0b9-a8161c2614572025-01-10WarningsExact identifier
application number: M020
CoTZ BabyZINC OXIDEFallien Cosmeceuticals, LTD17cc12c7-5af8-413f-b205-31ac150583e22025-01-09WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.2b3bdbe1-ede9-cd60-e063-6394a90ab2f32025-01-09WarningsExact identifier
application number: M020
JAFRA ROYAL REVITALIZE 4 TUBE SETAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca982025-01-09WarningsExact identifier
application number: M020
glo SKIN BEAUTY Moisturizing Tint SPF 30GLO SKIN BEAUTY MOISTURIZING TINT SPF 30Hayden Caleel LLC2b464a70-8f40-3148-e063-6394a90ac18c2025-01-09WarningsExact identifier
application number: M020
Sunscreen and insect repellent Bull frogSPF 50Bullfrog Brands, LLCd65d15a6-0a32-1203-e053-2995a90aa6c52025-01-09WarningsExact identifier
application number: M020
Sunscreen and insect repellent Bull frogSPF 50Bullfrog Brands, LLCd5fb3632-24da-2c7a-e053-2a95a90a50812025-01-09WarningsExact identifier
application number: M020
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENEW SEASON DERMATOLOGY, PLLCfecd72a3-c7e5-3dfa-e053-6394a90a73572025-01-09WarningsExact identifier
application number: M020
ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L41b3cf18-dc11-4e1d-802e-5ba25bd87adb2025-01-09WarningsExact identifier
application number: M020
ECLIPSE SPF 50 PERFECTINT BEIGETITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLCb69dda25-372f-15d9-e053-2995a90a8d3e2025-01-09WarningsExact identifier
application number: M020
PerfecTint Powder SPF 40 All ShadesZINC OXIDEScience of Skincarebb26c010-299e-3dc5-e053-2995a90a2c892025-01-09WarningsExact identifier
application number: M020
Extreme Protect SPF 40 All ShadesZINC OXIDE, TITANIUM DIOXIDEScience of Skincare, LLC.b69db78b-5f0e-8ca2-e053-2a95a90ac88c2025-01-09WarningsExact 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