SPF 50 Face Sunscreen

Product NDC
49825-201
11-digit product format
498250201
Labeler code
49825
Product ID
49825-201_5ed59160-c864-4991-e063-6294a90aedc5
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
2027-12-31
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
2027-12-31

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#

Effective, Related label table
EffectiveRelated label
2024-08-27SPF 50 Face Sunscreen
2024-08-27SPF 50 Face Sunscreen
2024-01-30SPF 50 Face Sunscreen
2024-01-30SPF 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 260 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDEZINC OXIDE9055-7588 Quebec Inc. DBA Attitude06245c8c-93e8-4ebb-bab0-3db64dc178b92024-12-09WarningsExact identifier
application number: M020
BANANA BOAT KIDS SPF 65 CLEAR SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc7b0d17-d7c8-433f-e053-2995a90a477d2024-12-09WarningsExact identifier
application number: M020
Sheer Zinc SPF 30ZINC OXIDEAllure Labsb6b45dac-41d0-1b55-e053-2a95a90acf612024-12-09WarningsExact identifier
application number: M020
Broad Spectrum SPF30 Mineral SunscreenZINC OXIDEAllure Labsdafc8e62-7c99-1f6d-e053-2995a90a77912024-12-09WarningsExact identifier
application number: M020
Prevention Daily Tinted Moisturizer SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labsed883d63-777c-e924-e053-2995a90a162a2024-12-09WarningsExact identifier
application number: M020
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen MahoganyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdcba05ff-7a68-c5c0-e053-2a95a90a61292024-12-09WarningsExact identifier
application number: M020
Prevention Daily Matte Moisturizer SPF 30ZINC OXIDE AND HOMOSALATEAllure Labsf0fb1b69-53f2-efff-e053-2995a90af9d42024-12-09WarningsExact identifier
application number: M020
MD Restoring daily Defense Moisturizer SPF 50ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs Inceb8e7109-b5eb-5cc1-e053-2995a90a486f2024-12-09WarningsExact identifier
application number: M020
Prevention Sun Serum SPF 30 TintedZINC OXIDEAllure Labsf1761b09-9061-a052-e053-2a95a90a39c82024-12-09WarningsExact identifier
application number: M020
Prevention Sun Serum SPF30ZINC OXIDEAllure Labsf188669f-7b9f-6e01-e053-2995a90afa3c2024-12-09WarningsExact identifier
application number: M020
Prevention Clear Solar Gel SPF30AVOBENZON, OCTISALATE AND OCTOCRYLENEAllure LAbsf19f6d9b-5249-27a6-e053-2a95a90a8a392024-12-09WarningsExact identifier
application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen TintedZINC OXIDEAllure Labs02e7fb00-2039-c4f8-e063-6294a90a418f2024-12-09WarningsExact identifier
application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen UntintedZINC OXIDEAllure Labs02f9c859-8d7d-5146-e063-6394a90a57b52024-12-09WarningsExact identifier
application number: M020
Quench and Protect Hydrating SPF30ZINC DIOXIDE AND TITANIUM DIOXIDEAllure Labs.039e50c1-7b3d-d392-e063-6394a90a4b3c2024-12-09WarningsExact identifier
application number: M020
Tinted Face Cream SPF 15OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC0d7300ee-adf4-41be-bb9f-257cd2986c0f2024-12-06WarningsExact identifier
application number: M020
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50TITANIUM DIOXIDE, ZINC OXIDEBeautcella Inc.bad942d8-04da-31d2-e053-2a95a90a92752024-12-06WarningsExact identifier
application number: M020
TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDETOM FORD BEAUTY DIST289b824f-bb0b-313e-e063-6394a90ab7832024-12-06WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d840001-a648-df1b-e063-6294a90ab2992024-12-06WarningsExact identifier
application number: M020
Performance Face Sunscreen Broad Spectrum SPF 30ZINC OXIDE, OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC1629f061-b8fc-4fda-8378-c64e164d41bd2024-12-06WarningsExact identifier
application number: M020
Clear System Brightening Day Cream SPF 15OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC8cbc8fa4-469f-4fa3-bd8e-27e815989c3f2024-12-06WarningsExact 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