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 111 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b0ac77-13d8-4259-e063-6394a90a893b2025-12-17Exact identifier
application number: M020
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b000e3-2516-932c-e063-6294a90a0e412025-12-17Exact identifier
application number: M020
Moisturizing Mineral Sunscreen TintedZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b12dbc-5edc-aad1-e063-6394a90a42ea2025-12-17Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b1a6c8-b4ff-089a-e063-6394a90a24692025-12-17Exact identifier
application number: M020
Badger SPF 40 Tinted Mineral FaceZINC OXIDEW.S. Badger Company, Inc.4628c04f-b7a6-b3fe-e063-6294a90a16752025-12-17WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc0a5a4d0e-8ab2-3d79-e063-6394a90a70062025-12-17WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 10%, OCTOCRYLENE 5%Beiersdorf Inc0a5a42a3-6fe4-2980-e063-6394a90a54fe2025-12-17WarningsExact identifier
application number: M020
Coppertone Glow Suncreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdord Incb65c117d-f200-bb22-e053-2995a90ab71d2025-12-17WarningsExact identifier
application number: M020
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shadesZINC OXIDE AND TITANIUM DIOXIDENoxell2cdbeb73-b805-f144-e063-6294a90a088d2025-12-17WarningsExact identifier
application number: M020
Covergirl Clean Fresh Blurring Skintint SPF 30 Mineral Sunscreen Liquid Foundation- All shadesZINC OXIDENoxell3fa58ac5-f45c-369a-e063-6294a90a46e42025-12-17WarningsExact identifier
application number: M020
Ray Defense Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBioelements807db1ff-a64a-44e4-a786-f88cd45184332025-12-17WarningsExact identifier
application number: M020
SPF 50 Face Sunscreen BioelementsAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBioelements, Inc981c7b3c-d7d6-483d-bf32-10d526be5b3f2025-12-17WarningsExact identifier
application number: M020
Glow Oil SPF 50 Beach FlowerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC2a46d7d2-293f-5024-e063-6294a90a31aa2025-12-17WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Inc0f114022-daaa-1834-e063-6394a90afd1d2025-12-17WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Inc0f113048-adfb-7d2a-e063-6294a90a20122025-12-17WarningsExact identifier
application number: M020
Coppertone Oil Free and Shine Control Face Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incf3d163b4-6774-4c2e-e053-2a95a90afd592025-12-17WarningsExact identifier
application number: M020
Coppertone EveryTone Face Sunscreen SPF 55AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc04b12f39-778c-ecee-e063-6394a90afa242025-12-17WarningsExact identifier
application number: M020
Skin On Skin BC Foundation SPF 40 - Fair CoolOCTISALATE, HOMOSALATE, ZINC OXIDEYENSA Beauty, LLC462e9a4a-ef28-0e0e-e063-6394a90ab4f82025-12-17WarningsExact identifier
application number: M020
Mattifying Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienceb27d7df0-3c84-4cc5-9ef3-07105311fed92025-12-17WarningsExact identifier
application number: M020
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.45d101be-2b88-4759-9ccc-556f5ec0553d2025-12-17WarningsExact 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