FDA.reportPublic FDA data

GroomWell Weightless with Mineral Broad Spectrum SPF 15 Sunscreen

Product NDC
42508-827
11-digit product format
425080827
Labeler code
42508
Product ID
42508-827_e3b232de-92f6-4220-b839-26701b62e0fd
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Arbonne International, LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-04-27
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
50 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42508-827DDiscontinued by firm2026-10-16
excluded packagepackage42508-82742508-827-23DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42508-827-23GroomWell Weightless with Mineral Broad Spectrum SPF 15 Sunscreen50 g in 1 JARCREAM504
42508-827-23GroomWell Weightless with Mineral Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42508-827GROOMWELL WEIGHTLESS WITH MINERAL BROAD SPECTRUM SPF 15 SUNSCREEN (ZINC OXIDE) CREAM [ARBONNE INTERNATIONAL, LLC]4Legacy NDC, 2 package rows20241115_3c0e3a90-1cfb-4a6a-b36b-931c839fec25.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42508-827-23425080827231 JAR in 1 CARTON (42508-827-23) > 50 g in 1 JAR1 jar2021-04-270000-00-00NoNoCurrent