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 163 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunsolve MD Volumize and Condition LipZINC OXIDESunsolve MD396b7462-d597-4bf7-e063-6394a90ab58d2025-11-14WarningsExact identifier
application number: M020
Sunsovle MD Volumize and RestoreZINC OXIDESunsolve MD Inc26f3cdda-b990-15cb-e063-6394a90ade292025-11-14WarningsExact identifier
application number: M020
Naturium Dew-Glow Moisturizer SPF 50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc0a5b80fb-caeb-eb56-e063-6294a90a238b2025-11-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d82f310-f87a-f76d-e063-6294a90af2512025-11-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-deepHOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d865e74-1baf-6a44-e063-6394a90a37ac2025-11-14WarningsExact identifier
application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-mediumHOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc.0d8616a8-2eab-c85c-e063-6294a90a39842025-11-14WarningsExact identifier
application number: M020
Naturium UV Reflect Antioxidant SPF 50HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f. Cosmetics, Inc0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c2025-11-14WarningsExact identifier
application number: M020
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc372894af-bed7-474f-95d4-69a8c3f215ef2025-11-14WarningsExact identifier
application number: M020
HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEONEAND CO., LTD.2dc41560-f4a7-5f0b-e063-6294a90a06302025-11-13WarningsExact identifier
application number: M020
Covey Sun and Done Daily MoisturizingZINC OXIDECovey Skinfbcf8204-0673-99aa-e053-6294a90ac26e2025-11-13WarningsExact identifier
application number: M020
SOL Science The FiftyZINC OXIDEBeauty Pie01548858-8b0e-494a-e063-6294a90a8e992025-11-13WarningsExact identifier
application number: M020
Balmere Mineral Sunscreen Moisturizer PrimerZINC OXIDEBalmere00d813e0-eb97-a6ba-e063-6394a90aa5252025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION FRESH PEACH DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever437eb2a8-428c-8339-e063-6394a90a74b22025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION ORIGINAL CLEAN DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever437f4db5-552f-1550-e063-6394a90aaedb2025-11-13WarningsExact identifier
application number: M020
Depology Essential Mineral UV CareZINC OXIDEDepology Holdings LLC1d48cdee-be67-14c0-e063-6294a90a74222025-11-13WarningsExact identifier
application number: M020
Hanalei Face MoisturizingZINC OXIDEHanalei Beauty Company LLC1f7c1a68-5aea-0deb-e063-6394a90a3a432025-11-13WarningsExact identifier
application number: M020
Glo SkinTITANIUM DIOXIDE, ZINC OXIDEGlo Skin Beautyf4bed574-68c1-0d2c-e053-2a95a90a15ff2025-11-13WarningsExact identifier
application number: M020
Dove Clinical Care96H PROTECTION SOFT SENSITIVE DRY SPRAY ANTIPERSPIRANT DEODORANTConopco d/b/a Unilever4380036a-7698-03e7-e063-6294a90a73012025-11-13WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL AIR FIT SUNSCREENSUNSCREENTPERENNEBELLfe2148db-9020-9343-e053-6294a90adf702025-11-13WarningsExact identifier
application number: M020
skin MDOCTINOXATE, OCTISALATE, HOMOSALATE21st Century Formulationse809e1d3-0a6d-730d-e053-2a95a90aedb92025-11-13WarningsExact 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