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 73 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade FourZINC OXIDEClean Beauty For All, Inc (dba Saie)1922e001-e699-7ac5-e063-6394a90a25d92026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade SixZINC OXIDEClean Beauty For All, Inc (dba Saie)a9350360-7932-459f-806c-399fa265e6c02026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade ThreeZINC OXIDEClean Beauty For All, Inc (dba Saie)1923067f-1ab9-d168-e063-6394a90adbd02026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922ee84-d7d0-80b1-e063-6394a90acf7b2026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade SevenZINC OXIDEClean Beauty For All, Inc (dba Saie)310a07bb-d32a-401f-955e-4c2860148a302026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade FiveZINC OXIDEClean Beauty For All, Inc (dba Saie)39ae4a97-7f96-4c95-a6de-0c779764fb022026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc3e-055c-e51d-e063-6294a90a00f52026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade NineZINC OXIDEClean Beauty For All, Inc (dba Saie)9c7a31df-5bdd-403b-b807-1d1a801e1bb62026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade OneZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc51-ae53-acb8-e063-6394a90a14eb2026-01-20WarningsExact identifier
application number: M020
Wrinkle Repair Moisturizer SPF 30 EQBAVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2%Walmarta067e968-e598-40ef-95f2-c338b5e413dd2026-01-20WarningsExact identifier
application number: M020
Welmedix HomeCare PRO Fragile Skin Dual Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEWelmedix LLC48da4589-0f5a-c25b-e063-6394a90ac18b2026-01-20WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen KidsZINC OXIDE 14.69%S&C Hampton Sun LLC0bdb7d15-dc52-4e23-9417-fe73f17f61102026-01-20WarningsExact identifier
application number: M020
DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICKOCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATEDEWYTREE CO. ,LTD48406e68-eefd-d2c2-e063-6394a90a4ad92026-01-20WarningsExact identifier
application number: M020
KONEUK SUNSCREEN SPF50KONEUK SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.48dd7f6e-2a4d-2c92-e063-6294a90a42552026-01-20WarningsExact identifier
application number: M020
CHUDAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEPremier Ocher LLC1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f2026-01-20WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
application number: M020
PROJECT REEF SPF-30 Mineral SunscreenZINC OXIDEProject Reef LLCa6077e6f-d987-4159-946f-3e23972476592026-01-19WarningsExact identifier
application number: M020
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
application number: M020
SABAL Mineral Sunscreen Broad Sprectrum SPF 30ZINC OXIDESABAL SUN LLCf917b446-4e10-4231-826e-fdac32e111862026-01-19WarningsExact identifier
application number: M020
Plius Daily SPF Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEPLIUS, Inc31866de9-afa0-4c11-be65-b613735514932026-01-19WarningsExact 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