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 184 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVEAVOBENZONE, HOMOSALATE, OCTISALATEMDSolarSciences3fa810b0-0211-f2a7-e063-6294a90a0b722025-09-25WarningsExact identifier
application number: M020
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
application number: M020
HygieneLab Face and Body Mineral Sunscreen SPF 50ZINC OXIDEHYGIENELAB, INC7db103da-b434-433a-a18f-a727165640c02025-09-24WarningsExact identifier
application number: M020
Eve Lom Daily Protection Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENESpace Brands Limited0e2c9ffb-036d-49c5-abdb-2ee8888df3182025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint DG6ZINC OXIDEPUR Minerals3f8e97a7-2023-ba9c-e063-6294a90ac9c92025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN7ZINC OXIDEPUR Minerals3f0717c7-f43f-e3b1-e063-6394a90a74dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN2ZINC OXIDEPUR Minerals3f06ed2f-f43f-53d4-e063-6294a90af0dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint MN4ZINC OXIDEPUR Minerals3f06f618-f7b2-53d0-e063-6294a90a829c2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint MN3ZINC OXIDEPUR Minerals3f06df49-5ed2-44ca-e063-6294a90a1fda2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LN2ZINC OXIDEPUR Minerals3f069dfe-289d-8d3b-e063-6394a90a04962025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint LG3ZINC OXIDEPUR Minerals3f06ec3e-fc15-9f7b-e063-6394a90a07332025-09-24WarningsExact identifier
application number: M020
Volition Prismatic Luminizing ShieldZINC OXIDEVolition1a633c24-b9d9-4732-e063-6294a90af4c02025-09-24WarningsExact identifier
application number: M020
Alleyoop Sunsational Broad SpectrumZINC OXIDENewAlley Innovations Inc248419c4-8044-402c-e063-6394a90a00f82025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 30 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 7.5%, OCTISALATE 5.0%Aloe Upf7b2d4a2-3a0d-4239-b7e5-8de2f6ac2e922025-09-24WarningsExact identifier
application number: M020
pavise Dynamic Age DefenseZINC OXIDEB.A.I BIOSCIENCES, INCf4e9f95c-6b1e-d5f7-e053-2a95a90a93ce2025-09-24WarningsExact identifier
application number: M020
Aloe Up SPF 50 coco-mango mistAVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%Aloe Upd535b711-c54e-4447-9907-ca9d829d13192025-09-24WarningsExact identifier
application number: M020
ESPOIR WATER SPLASH SUN SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEESPOIR Corporation1c4e7ba2-05e8-f949-e063-6394a90a699d2025-09-23WarningsExact identifier
application number: M020
Banana BoatZINC OXIDEEdgewell Personal Care Brands LLC1d11c3d0-5f4e-0ed0-e063-6294a90abc752025-09-23WarningsExact identifier
application number: M020
Dewscreen Daily Hydrator and Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3f7c84e3-0e4f-b7e9-e063-6294a90a12952025-09-23WarningsExact identifier
application number: M020
Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC15d8574d-94bb-4842-e063-6394a90a15e62025-09-23WarningsExact 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