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 95 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd474fea9-65a7-672b-e053-2a95a90ab9892025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 40AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incd4d9ad73-6394-2391-e053-2a95a90a2df62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incdf498e82-e1c9-51eb-e053-2a95a90a49b62025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd3984138-763b-1002-e053-2995a90acefc2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd8b0d5ad-a82c-5304-e053-2a95a90afa632025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incd8d80a15-8282-a18e-e053-2a95a90a2c6c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd915cb28-2813-5a38-e053-2a95a90a45c62025-12-31WarningsExact 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