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 238 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECLIPSE SPF 50 ALL SHADESTITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLC49df51e6-be9a-41be-b3e1-bfc062aaceaa2025-01-09WarningsExact identifier
application number: M020
CoTZ Mineral Suns Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD44a6ff9b-8067-4f32-acb2-4ede54c79e6e2025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNKISSEDZINC OXIDE SUNSCREENBentley Laboratories, LLCc45b59d8-0196-4dce-bfaa-57c47f655fe82025-01-09WarningsExact identifier
application number: M020
TiZO Tinted Lip Protection SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a22025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1088fbf6-5790-490d-b272-ec281b4b76fa2025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDf106f52b-2157-46c7-9f7c-50f43a6490502025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKSZINC OXIDE SUNSCREENBentley Laboratories, LLC5c98bacb-8bbd-47b8-8987-50be1ed34fc02025-01-09WarningsExact identifier
application number: M020
CoTZ Face MoistureZINC OXIDEFallien Cosmeceuticals, LTDdb682516-6c8f-4009-a9ec-e21dfc64ce152025-01-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light MediumOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautybcd22c9a-2db6-4653-9ab5-825f3f5cc4202025-01-08WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 LightOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautyc66c2a54-97c8-4904-a44a-b3cf790837f52025-01-08WarningsExact identifier
application number: M020
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETempo Industries, Inc.af9aa56d-2f8a-55b9-e053-2a95a90a32582025-01-08WarningsExact identifier
application number: M020
Baby Mineral Sunscreen Probiotics SPF55ZINC OXIDEHello Bello0191b2e4-bcc5-541a-e063-6294a90a0e782025-01-08WarningsExact identifier
application number: M020
Kids Face and Body Sunscreen SPF 50ZINC OXIDEHello Bello01cc4ea0-e3de-32f1-e063-6394a90a13752025-01-08WarningsExact identifier
application number: M020
Baby Mineral Sunscreen SPF55ZINC OXIDEHello Bello0190eeaf-c5a0-3253-e063-6294a90a43c42025-01-08WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50ZINC OXIDEHello Bello01cc205b-a345-262a-e063-6394a90a955c2025-01-08WarningsExact identifier
application number: M020
Eco Lips Zinc SPF 30 Broad Spectrum Sunscreen UnscentedZINC OXIDEEco Lips, Inc.febabad6-0bf2-a3f8-e053-6294a90a3aeb2025-01-08WarningsExact identifier
application number: M020
LESS EVERY TONE SPF 30ZINC OXIDEHappy Farm Botanicals, Inc.e91ded4b-987d-17a8-e053-2995a90adc2e2025-01-08WarningsExact identifier
application number: M020
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEETHEREAL AESTHETICS LLC065d17cf-bea5-137f-e063-6394a90aeeb32025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESERRAO, E JOHN MD FACOGfea61544-6684-ad34-e053-6294a90a48f32025-01-08WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENew Beginnings Tattoo Removalfea87de3-116f-4774-e053-6394a90a0aad2025-01-08WarningsExact 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