SPF 50 Face Sunscreen

Product NDC
49825-201
11-digit product format
498250201
Labeler code
49825
Product ID
49825-201_462ab8c8-dd89-a7d5-e063-6394a90a6c66
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Bioelements, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-04
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
3; 10; 7; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49825-201-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49825-201-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49825-201-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49825-201-021332a3947898…d4bfe170f9cd…

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
SPF 50 Face Sunscreen
Brand name suffix
Bioelements
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE10 g/100mL
OCTINOXATE7 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE5 g/100mL
OXYBENZONE6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
981c7b3c-d7d6-483d-bf32-10d526be5b3fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-201-022024-08-27C16284748780-11030e365-45af-111a-e063-dadaa90a10e2SPF 50 Face Sunscreen
49825-201-022024-01-30C16284748780-11030e365-45af-111a-e063-dadaa90a10e2SPF 50 Face Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-201-01SPF 50 Face SunscreenBioelements68 mL in 1 TUBECREAM685
49825-201-02SPF 50 Face SunscreenBioelements1 in 1 BOXCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-201SPF 50 FACE SUNSCREEN BIOELEMENTS (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [BIOELEMENTS, INC]4Current NDC, Legacy NDC, 2 package rows20240829_981c7b3c-d7d6-483d-bf32-10d526be5b3f.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 201 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 07N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Ld4c76bc5-205b-45fd-8a02-4f4b174585032025-08-04WarningsExact identifier
application number: M020
AHAVA Extreme Daily Firmness And Protection Broad Spectrum SPF30HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltdb22af9ef-4b69-4e70-a65d-f421e1d178af2025-08-01WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC3b4dbc5a-0754-0e71-e063-6394a90aa63c2025-08-01WarningsExact identifier
application number: M020
Kids Tallow Sunscreen SPF50NON-NANO ZINC OXIDE 25%FOUNDATION COMMERCE INC3b4eca91-965f-66c6-e063-6394a90a78ca2025-08-01WarningsExact identifier
application number: M020
Vigority Tallow Sunscreen SPF30NON-NANO ZINC OXIDE 19%FOUNDATION COMMERCE INC3b4f5941-15ae-a760-e063-6394a90a2abe2025-08-01WarningsExact identifier
application number: M020
Pipette Mineral Sunscreen SPF 50ZINC OXIDEPipette LLC3a10657a-bc16-181d-e063-6294a90a485b2025-08-01WarningsExact identifier
application number: M020
No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3f0500cc-013b-7069-e063-6294a90a1a5f2025-08-01WarningsExact identifier
application number: M020
Daily Antioxidant Mineral SunscreenZINC OXIDEMONIKA G KIRIPOLSKY MD INC.3b3d7ff2-1463-8d8e-e063-6394a90a5ac82025-07-31WarningsExact identifier
application number: M020
Shaklee Shield Sheer Mineral Body Sunscreen SPF 30ZINC OXIDEShaklee Corpc9b8e04c-11ee-4c4f-8693-aa4dc6e66aca2025-07-31WarningsExact identifier
application number: M020
Equate SUNSCREEN spf 50 SPORT broadspectrumAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEWalmart4e5280b2-1437-4d97-bb4c-db1a1632fea72025-07-31WarningsExact identifier
application number: M020
Tallow Sunscreen SPF 30NON-NANO ZINC OXIDE 19%FOUNDATION COMMERCE INC3b410ed7-c629-e39c-e063-6294a90a12f62025-07-31WarningsExact identifier
application number: M020
Face Reality Brilliant Defense Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce42025-07-29WarningsExact identifier
application number: M020
Face Reality Power Mineral Sunscreen SPF 50ZINC OXIDEFace Reality,LLC8c502e11-6e97-46d6-8775-1bbafaeb18f82025-07-29WarningsExact identifier
application number: M020
SPF30 unseen sunscreen stick 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3afa3bdb-e924-55c1-e063-6394a90af3522025-07-28WarningsExact identifier
application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC003123d2-9675-fdd2-e063-6294a90a01302025-07-28WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20e0badf-fe25-1d27-e063-6294a90a7cfe2025-07-28WarningsExact identifier
application number: M020
Basin Santas Cookies SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b016dcf-fb74-916f-e063-6294a90a683d2025-07-28WarningsExact identifier
application number: M020
Basin Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3b01c6a4-2230-c83e-e063-6294a90aa66d2025-07-28WarningsExact identifier
application number: M020
Basin Peppermint Swirl SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b022c84-00a5-ece9-e063-6294a90a09bd2025-07-28WarningsExact identifier
application number: M020
Basin Winter Berry Blast SPF15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b02c3f2-a43a-0d29-e063-6394a90a76b52025-07-28WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49825-201-014982502010168 mL in 1 TUBE68 mlHistorical
49825-201-02498250201021 TUBE in 1 BOX (49825-201-02) / 68 mL in 1 TUBE (49825-201-01) 1 tube2016-01-040000-00-00NoNoCurrent