FDA.reportPublic FDA data

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 130 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359641c5-0e19-f243-e063-6394a90aeebc2025-12-12Exact identifier
application number: M020
Satin TintZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359684cf-ca11-f9af-e063-6394a90ac4c12025-12-12Exact identifier
application number: M020
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
application number: M020
JAYSUING Rice Probiotics SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.45cdc741-9ce0-fd6c-e063-6294a90adc0b2025-12-12WarningsExact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
application number: M020
Signature Tint SPF 40ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348f1bd3-1245-2d9a-e063-6394a90a47872025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a54441-c741-0c46-e063-6294a90a9be82025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37620171-140d-e096-e063-6294a90af93b2025-12-11Exact identifier
application number: M020
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a52011-b781-75cf-e063-6394a90ae0f42025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a632f5-4458-e335-e063-6394a90a9bcb2025-12-11Exact identifier
application number: M020
D FEND DAILYZINC OXIDECLEAN BEAUTY BY ANAK LLC3762dc16-055e-43fd-e063-6394a90ad3c82025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a66140-0d36-005a-e063-6394a90a2a0b2025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37634726-fb70-f209-e063-6294a90a5d3b2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
application number: M020
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact 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