FDA.reportPublic FDA data

SPF-30 BB

Product NDC
69090-0100
11-digit product format
690900100
Labeler code
69090
Product ID
69090-0100_8161e716-0188-41c2-b2c9-7041d34503db
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
ZION HEALTH
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-20
Substance
ZINC OXIDE
Active strength
20 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct69090-0100UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69090-010069090-0100-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
SPF-30 BB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100mL

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
66d33d8c-8900-4698-98fe-0dedafe674d8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69090-0100-12023-02-23C16284748780-1f386c649-decd-0266-e053-dadaa90a7c1aSPF-30 BB CREAM
69090-0100-12023-01-30C16284748780-1f386c649-decd-0266-e053-dadaa90a7c1aSPF-30 BB CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69090-0100-1SPF-30 BB110 mL in 1 TUBELOTION1105

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQYSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
MONTMORILLONITEINACTIVE INGREDIENTA585MN1H2LSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
POLYGLYCERYL-10 LAURATEINACTIVE INGREDIENTMPJ2Q8WI8GSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ASPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YISPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8SPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1
WATERINACTIVE INGREDIENT059QF0KO0RSPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69090-0100SPF-30 BB (ZINC OXIDE) LOTION [ZION HEALTH]5Current NDC, Legacy NDC, 1 package rows20250116_66d33d8c-8900-4698-98fe-0dedafe674d8.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 130 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Matte Velvet TintTITANIUM DIOXIDE, ZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359641c5-0e19-f243-e063-6394a90aeebc2025-12-12Exact identifier
application number: M020
Satin TintZINC OXIDEBrent Loftis, D.O., Inc., A California Medical Corporation359684cf-ca11-f9af-e063-6394a90ac4c12025-12-12Exact identifier
application number: M020
TINTED MINERAL SUNSCREEN SPF 40TITANIUM DIOXIDE, ZINC OXIDEDERMATOLOGY ARTS35814d5d-fd34-05b3-e063-6294a90aadd12025-12-12Exact identifier
application number: M020
JAYSUING Rice Probiotics SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.45cdc741-9ce0-fd6c-e063-6294a90adc0b2025-12-12WarningsExact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELA HAIR DESIGN36eb4cd3-778c-362f-e063-6294a90a059c2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37630c6c-f768-7b3e-e063-6394a90af5652025-12-11Exact identifier
application number: M020
Signature Tint SPF 40ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348f1bd3-1245-2d9a-e063-6394a90a47872025-12-11Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEADVANCED AESTHETICS SKIN CARE STUDIO, INC348fcc63-d8e3-90a1-e063-6294a90ade112025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a54441-c741-0c46-e063-6294a90a9be82025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37620171-140d-e096-e063-6294a90af93b2025-12-11Exact identifier
application number: M020
SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique Aesthetics Pllc34a49563-c74b-2fd1-e063-6394a90a6c562025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a52011-b781-75cf-e063-6394a90ae0f42025-12-11Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a632f5-4458-e335-e063-6394a90a9bcb2025-12-11Exact identifier
application number: M020
D FEND DAILYZINC OXIDECLEAN BEAUTY BY ANAK LLC3762dc16-055e-43fd-e063-6394a90ad3c82025-12-11Exact identifier
application number: M020
Tinted SunscreenZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a66140-0d36-005a-e063-6394a90a2a0b2025-12-11Exact identifier
application number: M020
Instant GlowZINC OXIDECLEAN BEAUTY BY ANAK LLC37634726-fb70-f209-e063-6294a90a5d3b2025-12-11Exact identifier
application number: M020
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
application number: M020
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
application number: M020
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69090-0100-169090010001110 mL in 1 TUBE (69090-0100-1) 110 ml2014-01-200000-00-00NoNoCurrent