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 239 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheglam Dew and Done Skin Tint with SPF 20 NudeZINC OXIDEEVER FAME PTE. LTD.2abd8527-72a5-1564-e063-6294a90ad8d32025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 NutmegZINC OXIDEEVER FAME PTE. LTD.2abdda5e-0f52-ae46-e063-6394a90ae6f52025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 PorcelainZINC OXIDEEVER FAME PTE. LTD.2abdddbc-d891-7c4d-e063-6294a90a81622025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 RussetZINC OXIDEEVER FAME PTE. LTD.2abe084b-7478-e923-e063-6394a90ac9412025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 PeachZINC OXIDEEVER FAME PTE. LTD.2abdca50-ffc4-8c36-e063-6394a90af7662025-01-02WarningsExact identifier
application number: M020
Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3bacceb-63a8-098c-e053-2995a90acd642025-01-02WarningsExact identifier
application number: M020
Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16ZINC OXIDEREJUVA MINERALS INC3d83c220-1801-4193-b6a8-c777f412c1732025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SaddleZINC OXIDEEVER FAME PTE. LTD.2abf69c5-07d7-252d-e063-6394a90a292b2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SandZINC OXIDEEVER FAME PTE. LTD.2abf7869-4418-7738-e063-6394a90ae89d2025-01-02WarningsExact identifier
application number: M020
Good Weather Skin The One Daily Sun SPF 30ZINC OXIDEGood Weather Inc.2ac30544-5ece-18ed-e063-6394a90a6a0d2025-01-02WarningsExact identifier
application number: M020
Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plusOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.283c2780-5ad5-38f1-e063-6294a90ac3362025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aabf782-65f9-e894-e063-6394a90a1ea32025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aad5b97-e64b-c678-e063-6294a90aa8c62025-01-01WarningsExact identifier
application number: M020
TIBENA ALWAYS REAL SUN BLOCK UV SPF 45AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEKONAD CO LTD2aafbd33-710a-201e-e063-6294a90ab1bb2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30ac897-3a30-7bba-e053-2995a90ac3422025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30b0588-b0f4-39a8-e053-2a95a90abb352025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30aeaa6-3423-401c-e053-2a95a90a8fe92025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30afd94-8bcd-01bc-e053-2a95a90afb492025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b156a-b9b1-499b-e053-2a95a90ada6a2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b183d-a54d-752c-e053-2a95a90a24fc2025-01-01WarningsExact 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