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 309 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Sugar SparkleHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE6174 INDUSTRIES, LLCcfd1e0c7-7e4c-41c1-8788-b73f83bf38c92024-03-06WarningsExact identifier
application number: M020
TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance FreeHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE6174 INDUSTRIES, LLC658b1b20-6540-4f3a-ac9a-170bc8fcba112024-03-06WarningsExact identifier
application number: M020
Daily Facial Moisturizer SPF 15 EQBAVOBENZONE 3% OCTOCRYLENE 10%Walmarta0c452a9-3e99-41b8-b9b2-c1b57b66f1832024-03-06WarningsExact identifier
application number: M020
Target Up and Up Sport SPF 50AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENETARGET CORPORATIONb81b2e7e-6d7f-fa1d-e053-2995a90a7d152024-03-06WarningsExact identifier
application number: M020
Target Up and Up Reef Conscious Formula SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENETARGET CORPORATIONb5fd43ee-9fa1-13c1-e053-2995a90a364a2024-03-06WarningsExact identifier
application number: M020
Vacation SPF 30 Baby OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f6030311-5287-3aa3-e053-2995a90a1b872024-03-06WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Nude TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e5493f-6478-0ff4-e063-6394a90af4f52024-03-05WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil CoralTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e65634-2e6d-b030-e063-6294a90ad1c42024-03-05WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil FigTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e7507d-6612-fda4-e063-6294a90a1db72024-03-05WarningsExact identifier
application number: M020
Dermachange SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPrivate Label Beauty and Wellness12f00cee-dd9b-19b1-e063-6294a90adccb2024-03-05WarningsExact identifier
application number: M020
Brush On Block Quick Stick SPF 40 Mineral StickZINC OXIDESPF Ventures LLC12d10ec9-847a-7483-e063-6294a90a42a72024-03-04WarningsExact identifier
application number: M020
Lucin Organics Tinted Sunscreen SPF 30 Non Nano Zinc OxideZINC OXIDELucin Organics, LLCd717dda8-60bb-40a0-86f9-6d724d695d162024-03-04WarningsExact identifier
application number: M020
Brush On Block Bounce Butter SPF 30 Moisturizing MousseZINC OXIDESPF Ventures LLC12956754-b4e5-0203-e063-6294a90a2b962024-03-01WarningsExact identifier
application number: M020
Derma E Sun Protection Mineral SPF 30ZINC OXIDEderma ebb8e3df2-23e8-4ad0-a662-ff02d156e7b12024-02-26WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEEdgewell Personal Care Brands, LLC39a5a3be-f9a7-4fa1-e054-00144ff88e882024-02-23WarningsExact identifier
application number: M020
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

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