FDA.reportPublic FDA data

Cream

Product NDC
61354-115
11-digit product format
613540115
Labeler code
61354
Product ID
61354-115_08a1e862-b55b-fb84-e063-6294a90a016a
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Oxygen Development LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-26
Substance
ZINC OXIDE
Active strength
21.76 mg/100mg
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
Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE21.76 mg/100mg

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
08a1e862-b55a-fb84-e063-6294a90a016aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-115-01Cream100 mg in 1 TUBECREAM1001
61354-115-02Cream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-115CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC]1Current NDC, 2 package rows20231030_08a1e862-b55a-fb84-e063-6294a90a016a.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 92 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f4599b-de62-2bc7-e063-6394a90a69ab2025-12-31WarningsExact identifier
application number: M020
Hawaiian Tropic Everyday Active SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc8e2ee8-e67f-ef5d-e053-2995a90a15202025-12-31WarningsExact identifier
application number: M020
Sunscreen Glowing, SPF 30SUNSCREEN GLOWING LOTIONCardinal Health, Inc28ed3b60-1139-f657-e063-6394a90a52fa2025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYCardinal Health, inc.293e9656-8644-b9aa-e063-6294a90a5b272025-12-31WarningsExact identifier
application number: M020
Sunscreen Setting Spritz, SPF 45SUNSCREEN SETTING SPRAYFSA Store Inc473d6804-8d20-6899-e063-6294a90a31312025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47428cd4-fbad-ba7a-e063-6394a90a1c5c2025-12-31WarningsExact identifier
application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47433a62-91e0-b031-e063-6294a90a0d492025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4743b6a9-4d79-1b2b-e063-6394a90a97102025-12-31WarningsExact identifier
application number: M020
Royal Jelly Radiance Foundation Broad Spectrum SPF 20 EarthOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.0edc7bd4-9350-48e1-bbfe-e6450458ae592025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - BronzeOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.90fbf555-106c-4131-b572-ead9bbb246e62025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - HoneyOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.1accbe67-c722-4af7-8422-0559ac4a987a2025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - BareOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5c0805c7-9b92-4c08-877c-64e7203084302025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20- NaturalOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.0cc5429d-ace4-4060-b993-1b607218eaf82025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20-NudeOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.b1851c5d-32ad-482a-bd24-2f280a68ef9e2025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 -SpiceOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.6164dc23-81c2-48b8-b309-2c5a81fe13a42025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4744e501-f12a-6d25-e063-6394a90a25742025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - TawnyOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.d7c4e758-3af2-40c6-bbe1-37e6fd0a5eb62025-12-31WarningsExact identifier
application number: M020
Radiance Foundation Broad Spectrum SPF 20 - CappuccinoOCTINOXATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.30601a73-089e-4fa7-8fb7-6b108498934a2025-12-31WarningsExact identifier
application number: M020
Good Karma Dry Oil Mineral Sunscreen SPF-30ZINC OXIDE SUNSCREENSOLARA SUNCARE, INC.209c4913-29e6-24ca-e063-6294a90a68722025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47456bf5-9f6c-e6a5-e063-6294a90a70542025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61354-115-0161354011501100 mg in 1 TUBE100 mgHistorical
61354-115-02613540115021 TUBE in 1 CARTON (61354-115-02) / 100 mg in 1 TUBE (61354-115-01) 1 tube2023-10-26NoNoCurrent