FDA.reportPublic FDA data

SABIYA Broad Spectrum SPF-50

Product NDC
84307-486
11-digit product format
843070486
Labeler code
84307
Product ID
84307-486_18020632-3cf1-4562-e063-6294a90ab1ad
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
SABIYA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-20
Substance
ZINC OXIDE
Active strength
180 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
SABIYA Broad Spectrum SPF-50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE180 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4264f23f-4f2a-4fd1-ad35-e7d649ee3f5cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84307-486-00SABIYA Broad Spectrum SPF-50100 mL in 1 TUBECREAM1001
84307-486-00SABIYA Broad Spectrum SPF-501 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84307-486SABIYA BROAD SPECTRUM SPF-50 (ZINC OXIDE) CREAM [SABIYA, LLC]1Current NDC, 2 package rows20240520_4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c.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 302 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burts Bees SPF 30 Untinted Lip Balm Beaches and CreamBURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAMAutumn Harp1ac89261-eeae-567c-e063-6294a90ad45f2024-06-13WarningsExact identifier
application number: M020
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.1acd3f09-87f2-75e4-e063-6394a90a0cd92024-06-13WarningsExact identifier
application number: M020
Mara Clear Skin Mineral Milk Acne TreatmentSALICYLIC ACIDMara Beauty LLC3823024e-81b4-4e29-af76-82231e09407c2024-06-13WarningsExact identifier
application number: M020
BOB KIDS SPF 30 Zinc onlyZINC OXIDESPF Ventures, LLC1aae0291-f16f-7840-e063-6394a90a34432024-06-12WarningsExact identifier
application number: M020
Glossier Invisible Shield SPF 50GLOSSIER INVISIBLE SHIELD SPF 50Autumn Harp1ab39eae-06e9-0e4c-e063-6394a90ad8aa2024-06-12WarningsExact identifier
application number: M020
BrushOnBlock Mineral Powder Sunscreen Broad Spectrum SPF30 TranslucentAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBrownkind Dermascience Inc.87ce977a-0ed2-451e-a0ac-976caf7424cc2024-06-10WarningsExact identifier
application number: M020
Thinksport SPF 50ZINC OXIDEthinkOperations,LLC2e83e382-8eb0-40f2-bdca-2db5e184661e2024-06-10WarningsExact identifier
application number: M020
Thinkkids SPF 50ZINC OXIDEthinkOperations,LLC09f9d9bb-c08b-401c-bbf1-640f1c8ec6782024-06-07WarningsExact identifier
application number: M020
NAELI Day Moisturizer Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEALLI LLCf2cebdc7-c96e-46cf-9b5c-b4965ddd2aec2024-06-06WarningsExact identifier
application number: M020
Youth 3 Activating BB Cream SPF 30 MediumZINC OXIDE, TITANIUM DIOXIDEShaklee Corporationccc80ea4-f270-4fd4-970c-eaa63df936e42024-06-06WarningsExact identifier
application number: M020
Thinkbaby SPF 50ZINC OXIDEthinkOperations,LLCf2788a1a-daf6-4b7d-8333-585a380ebe572024-06-05WarningsExact identifier
application number: M020
RMS SUNCOVERUP SUPER TINT SPF 50 ALABASTERZINC OXIDERms organics LLC1a11c884-d6ba-d77f-e063-6394a90a5bd22024-06-04WarningsExact identifier
application number: M020
toty Solaria BodyOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDECHIPICAN LLC1a121b17-3621-6bc1-e063-6394a90ac9a12024-06-04WarningsExact identifier
application number: M020
RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANYZINC OXIDERms organics LLC1a1aebea-ed0c-ac92-e063-6294a90aeae62024-06-04WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc OnlyZINC OXIDESPF Ventures, LLC1a1bf910-f1bc-bd75-e063-6294a90a663f2024-06-04WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
application number: M020
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEDerma Research Group Inc.19b19023-1340-6609-e063-6394a90a6eaf2024-05-30WarningsExact identifier
application number: M020
EltaMD UV Sport SPF50ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREENCP Skin Health Group, Inc.dffc3fde-5b6e-4a62-8289-9733be43455b2024-05-30WarningsExact identifier
application number: M020
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.aef8388f-84bb-4e2b-8ae2-aa64f415a6322024-05-28WarningsExact identifier
application number: M020
SPF50 Sunscreen CariposaZINC OXIDETalent Brands Company LLC1938fa13-875a-140e-e063-6294a90a55142024-05-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84307-486-00843070486001 TUBE in 1 BOX (84307-486-00) / 100 mL in 1 TUBE1 tube2024-05-20NoNoCurrent