FDA.reportPublic FDA data

Mineral Sunscreen SPF 50

Product NDC
54136-351
11-digit product format
541360351
Labeler code
54136
Product ID
54136-351_5dd63829-942f-d0f2-e063-6394a90a4c55
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Better Planet Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
ZINC OXIDE
Active strength
22 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Mineral Sunscreen SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE22 g/100g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54136-351-92Mineral Sunscreen SPF 5092 g in 1 TUBECREAM924

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54136-351MINERAL SUNSCREEN SPF 50 (ZINC OXIDE) CREAM [BETTER PLANET BRANDS LLC]3Current NDC, 1 package rows20250130_1d8e727c-8b50-9cf2-e063-6394a90a2e15.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 179 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kinesys Broad Spectrum SPF 50 Alcohol Free SunscreenOCTOCRYLENE, OCTINOXATE, HOMOSALATE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc998fe524-6469-4c9b-889b-3191882149ce2025-10-13WarningsExact identifier
application number: M020
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 BuffZINC OXIDECosmetic Enterprises Ltd265bc5e0-0a2a-842e-e063-6394a90aae0a2025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 MochaZINC OXIDECosmetic Enterprises Ltd2748b6bc-e80b-ce66-e063-6394a90a400a2025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 BronzeZINC OXIDECosmetic Enterprises Ltd265bf123-c4c3-8414-e063-6394a90a47302025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 IvoryZINC OXIDECosmetic Enterprises Ltd2748c351-0a7d-6913-e063-6394a90a6ef22025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 NudeZINC OXIDECosmetic Enterprises Ltd265bd73f-2509-90c6-e063-6294a90a2e192025-10-13WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCdad4b244-2d34-40cb-88dc-991358df83b02025-10-10WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeafc00ce-12e7-921f-e053-2995a90a241a2025-10-10WarningsExact identifier
application number: M020
KinesysOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc50adf1db-118f-4843-b356-e239931606732025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance FreeOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Ince0949325-7de1-4da4-82b6-8004916412a02025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d0294b-e937-336d-e063-6294a90a5c3c2025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free SunscreenOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc9adea1a4-efa6-4fe1-85e8-ed69fa098a872025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc60e7ed8e-f421-4e08-97a8-af647200e4ae2025-10-10WarningsExact identifier
application number: M020
KINeSYS Pro Sport Lip Balm with Shea Butter Broad Spectrum 30ZINC OXIDEWilc Healthcare Ince5820376-897f-4c77-aadc-7991137870b72025-10-10WarningsExact identifier
application number: M020
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45ZINC OXIDEWilc Healthcare Inc247a323f-9a08-4717-8553-ebc9c519817b2025-10-10WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d15366-85b8-f5e8-e063-6294a90a5fd82025-10-10WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4369f2f-fdc3-e48e-e053-2995a90a07f72025-10-10WarningsExact identifier
application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4ac746a-a50a-8041-e053-2a95a90a8ea62025-10-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54136-351-925413603519292 g in 1 TUBE (54136-351-92) 92 g2024-02-01NoNoCurrent