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 262 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Babo Botanicals Super Shield Sport Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.e3ca7840-4882-d605-e053-2a95a90af6ab2024-12-12WarningsExact identifier
application number: M020
Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural GlowMINERAL SUNSCREENBabo Botanicals, Inc.ab39d9f0-d869-6f33-e053-2995a90a08d42024-12-12WarningsExact identifier
application number: M020
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs88dedeb8-963f-5849-e053-2995a90aab722024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Extra Light TintZINC OXIDEMV Advanced7834c649-5f6d-b005-e053-2a91aa0a10842024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Light TintZINC OXIDEMV Advanced783649af-d746-84a3-e053-2991aa0a9e3d2024-12-12WarningsExact identifier
application number: M020
Everyday Coverage Tinted Sunscreen - Medium TintZINC OXIDEMV Advanced783649af-d768-84a3-e053-2991aa0a9e3d2024-12-12WarningsExact identifier
application number: M020
Babo SPF 30 Clear Zinc Fragrance Free SportMINERAL SUNSCREENBabo Botanicals, Inc.b1a9f76d-0cef-29da-e053-2995a90af34c2024-12-12WarningsExact identifier
application number: M020
Babo Baby Face Mineral SunscreenMINERAL SUNSCREENBabo Botanicals, Inc.b131664d-1ad2-0a2f-e053-2995a90acbda2024-12-12WarningsExact identifier
application number: M020
Babo SPF 30 Clear Zinc Fragrance FreeMINERAL SUNSCREENBabo Botanicals, Inc.b3e40cb0-dbfd-955c-e053-2995a90af8482024-12-12WarningsExact identifier
application number: M020
DOCTOR BABOR SOLAR DEFENSE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30ZINC OXIDEBABOR Cosmetics America Corp291ec801-ee15-06a4-e063-6294a90ab32b2024-12-12WarningsExact identifier
application number: M020
All Calm Clinical Redness Corrector SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColorescience68b95e94-3686-4d11-9952-ec86394376ee2024-12-12WarningsExact identifier
application number: M020
Method Men Face with Zinc Oxide SunscreenZINC OXIDEMethod Products Inc.cce5f8e1-cf40-4524-af2b-1d49309e28092024-12-12WarningsExact identifier
application number: M020
Sunforgettable Tint du Soleil Foundation SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEColorescience219e2ef4-e977-4527-8999-14b27d5a7a332024-12-12WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 50Plus SunscreenZINC OXIDEAbsolutely Natural4855c2c7-1516-4857-b103-2eb72a60d5d02024-12-11WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 30 SunscreenZINC OXIDEAbsolutely Naturalb6e8f361-fd31-4f21-9095-c5159a8261752024-12-11WarningsExact identifier
application number: M020
Walgreens Scar Cream w/SPF 30AVOBENZONE3%,OCTOCRYLENE10%,OXYBENONE 6%Walgreenscc72c8c5-f3e9-e8e0-e053-2a95a90ae0b02024-12-11WarningsExact identifier
application number: M020
ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lee9ae84b-c8fc-4a87-8910-46ec8ccfe1a92024-12-11WarningsExact identifier
application number: M020
ERBORIAN - BB CREME AU GINSENG DORE SPF 20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L121aa873-5ca6-426b-8ece-dcb5a9f82a032024-12-11WarningsExact identifier
application number: M020
ERBORIAN - CC CREME HIGH DEFINITION SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L3421b9a3-6551-406f-af3a-b3da8a01d2b22024-12-11WarningsExact identifier
application number: M020
ERBORIAN CC RED CORRECT SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELaboratoires M&L21530925-03b7-40bb-9836-6ee4011c4a792024-12-11WarningsExact 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