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 294 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BiocorneumAVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENEBiodermis LLCef95f2b7-e438-4990-880d-81621edb20022024-08-13WarningsExact identifier
application number: M020
TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and EZINC OXIDEFallien Cosmeceuticals, Ltd1f417082-5fd1-c95e-e063-6394a90a16ab2024-08-09WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1f4491ab-95b0-cc14-e063-6394a90a73ca2024-08-09WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb737146d-fb50-4ed6-ab5e-6aff3393992a2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior54b07420-6a30-4481-99f5-a7d6a4df898c2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65659277-cd30-453c-929e-3651c9f19da82024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior28ae9c39-eb79-4a19-8149-af8d8e7901ae2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior05f7119a-0c92-4393-a62d-8e84ec451d202024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb90ee1ba-17b5-4367-9df3-e9e27217960c2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorad5c5121-d75d-449d-a4db-a7b074787f682024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00OCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0018573d-922b-4642-9513-63481e9131d52024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior83b20b0d-c2db-4720-8434-57b73847ebca2024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior105651f2-3c99-4ff3-b67b-350a40dc88882024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7b1b551b-e78d-47ff-bb91-0d5f676c73fc2024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2411e8e6-a958-4fd9-b5e9-b9a32020ce542024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior062f61d2-a9a7-46e1-92e4-a6bdf257c1882024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9c3d513f-8331-4155-a77b-c358093a607c2024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2CROCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb7f8d1d0-1734-46a5-82fe-b0ac140175222024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3COCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc3849d5c-4f91-4147-aeb2-7461a3a943092024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4COCTISALATE, TITANIUM DIOXIDEParfums Christian Diore8f29488-10f8-4df6-b1f5-d9a670f60fca2024-08-06WarningsExact 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