FDA.reportPublic FDA data

Sun Bum Face 50 Premium Sunscreen SPF 50

Product NDC
44717-080
11-digit product format
447170080
Labeler code
44717
Product ID
44717-080_40d36900-8fdd-17ae-e063-6394a90ab565
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalte, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Wasatch Product Development, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Sun Bum Face 50 Premium Sunscreen SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4ac746a-a50a-8041-e053-2a95a90a8ea6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44717-080-01Sun Bum Face 50 Premium Sunscreen SPF 5088 mL in 1 TUBELOTION883

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44717-080SUN BUM FACE 50 PREMIUM SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) LOTION [WASATCH PRODUCT DEVELOPMENT, LLC]2Current NDC, 1 package rows20241024_f4ac746a-a50a-8041-e053-2a95a90a8ea6.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 304 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BB Tint 30 BS SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs1212448c-db88-26e6-e063-6294a90a3b9e2024-02-23WarningsExact identifier
application number: M020
Daily Prevention Pure Mineral Hydrating Moisturizer SPF30ZINC OXIDEAllure Labs11fce5ec-66e8-9eac-e063-6394a90aaf3a2024-02-22WarningsExact identifier
application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEPHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarinsbf31d19d-9520-4ac0-a4fd-2c285545f1b82024-02-20WarningsExact identifier
application number: M020
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint MediumHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins2c0964cd-607c-4219-b66e-cc99ada804342024-02-20WarningsExact identifier
application number: M020
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHTHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins6259442e-0c39-4887-8083-89253b64b5ff2024-02-20WarningsExact identifier
application number: M020
Meijer SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCSTISALATE 5%, OCTOCRYLENE 6%Meijer074b6340-0482-ab05-e063-6294a90adedb2024-02-19WarningsExact identifier
application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.11c37acc-abb8-8c38-e063-6294a90a79322024-02-19WarningsExact identifier
application number: M020
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltd11c461f7-0f34-65ff-e063-6294a90a3da72024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.11c61b92-89f4-692f-e063-6394a90a69cd2024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd11c651e2-072e-770e-e063-6394a90ad6fa2024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.11c65e7f-fe11-8115-e063-6394a90a85942024-02-19WarningsExact identifier
application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd11c6cf95-8923-af79-e063-6294a90a4f442024-02-19WarningsExact identifier
application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.118842ce-9d9b-80ce-e063-6394a90ab9862024-02-16WarningsExact identifier
application number: M020
CNP Laboratory Sun Care Milky Light Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd11894c1d-c199-dfc0-e063-6394a90a3f152024-02-16WarningsExact identifier
application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.711aa92c-81b0-42e4-b83f-9ce95116ec032024-02-16WarningsExact identifier
application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b8bc0021-bb4d-45f2-a570-3f2e61edf21d2024-02-16WarningsExact identifier
application number: M020
Meijer SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Meijer075dddd5-46ea-282a-e063-6294a90a28fd2024-02-15WarningsExact identifier
application number: M020
Sheet SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma Inc.bbb5b87c-d641-3ba2-e053-2a95a90a0f702024-02-14WarningsExact identifier
application number: M020
sheer tint SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b7c5cedd-ff68-74de-e053-2a95a90a37962024-02-14WarningsExact identifier
application number: M020
Weightless Protection SPF 45SUNSCREEN BROAD SPECTRUMCP Skin Health Group, Inc.b6bee26d-bffd-a8ee-e053-2a95a90affc52024-02-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44717-080-014471700800188 mL in 1 TUBE (44717-080-01) 88 ml2023-02-01NoNoCurrent