FDA.reportPublic FDA data

OS-01 Face SPF BS SPF30 Tinted

Product NDC
84451-002
11-digit product format
844510002
Labeler code
84451
Product ID
84451-002_2204e135-6a11-68a2-e063-6394a90ac019
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
2023-09-13
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 Tinted
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
2204e776-b1a1-be15-e063-6294a90af5deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84451-002-01OS-01 Face SPF BS SPF30 Tinted40 g in 1 TUBECREAM401
84451-002-02OS-01 Face SPF BS SPF30 Tinted1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84451-002OS-01 FACE SPF BS SPF30 TINTED (ZINC OXIDE) CREAM [ONESKIN INC.]1Current NDC, 2 package rows20240915_2204e776-b1a1-be15-e063-6294a90af5de.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 192 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coco and Eve Sunny Honey Protect SPF 50 Highlighter Body SPF 50SUNSCREENSoleil Collective LLC3d4c90e7-0716-4d57-e063-6394a90a43fa2025-08-26WarningsExact identifier
application number: M020
Sun Bum 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c4433e2-d383-8326-e063-6294a90aaf982025-08-26WarningsExact identifier
application number: M020
Coco and Eve Sunny Honey Protect SPF 50 Coconut Milk Body SPF 50SUNSCREENSoleil Collective LLC3d4d1b94-b1ce-cf94-e063-6394a90a61ba2025-08-26WarningsExact identifier
application number: M020
naked TURTLE 30ZINC OXIDENAKED TURTLE SUNSCREEN LLC65f1570a-6156-40e6-a792-e0707607dc2f2025-08-26WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF 50ZINC OXIDEDelta Ecommerce LLC2d490531-af38-87d0-e063-6394a90acf492025-08-25WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC20d24c9d-9558-156d-e063-6294a90a2d1a2025-08-25WarningsExact identifier
application number: M020
Neutrogena Sport Face Oil Free Sunscreen Broad Spectrum SPF 70 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC413275e8-0011-471e-9539-ea95ed8384132025-08-25WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - BananaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d34d144-2515-d7fa-e063-6294a90abb3f2025-08-25WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 sunscreenAVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 8.0%Florida Squeezed393b59aa-6d5a-4757-9f6d-59f7533aee862025-08-25WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d37ec29-8d15-c716-e063-6394a90ae7092025-08-25WarningsExact identifier
application number: M020
RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN ADOREZINC OXIDERms organics LLC3d386cc9-e097-dacf-e063-6294a90a8fe22025-08-25WarningsExact identifier
application number: M020
Baby Bum Mineral 50 Mineral Sunscreen Face StickZINC OXIDESun Bum, LLC3d3a0d5c-a366-22fc-e063-6394a90a308b2025-08-25WarningsExact identifier
application number: M020
BOB Kids Sun Balm SPF 40ZINC OXIDE 23%SPF Ventures, LLCefa5c501-273c-5e97-e053-2995a90a865b2025-08-24WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCe4a2e6e4-5c35-4178-b341-65644233b7b82025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC57f91218-2477-4495-98e8-c512d823e1582025-08-22WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCc358745d-b9c0-4a9e-9a83-caffa04ea2e52025-08-22WarningsExact identifier
application number: M020
Neutrogena Age Shield Face Oil Free Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC050c2997-3ec0-4515-8a67-709b07a5010f2025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf3e27d-ab16-4f12-e063-6394a90a70e22025-08-22WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC3cf42e31-4e11-9b6d-e063-6294a90aa7412025-08-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84451-002-018445100020140 g in 1 TUBE40 gHistorical
84451-002-02844510002021 TUBE in 1 CARTON (84451-002-02) / 40 g in 1 TUBE (84451-002-01) 1 tube2023-09-13NoNoCurrent