FDA.reportPublic FDA data

Mineral Sunscreen Lip Balm SPF 15

Product NDC
53675-184
11-digit product format
536750184
Labeler code
53675
Product ID
53675-184_7ee4548f-2c90-7bea-e053-2991aa0ab0c2
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-01-05
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
80 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct53675-184DDiscontinued by firm2026-10-12
excluded packagepackage53675-18453675-184-17DDiscontinued by firm2026-10-12

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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-184-17Mineral Sunscreen Lip Balm SPF 154.8 g in 1 APPLICATORLIPSTICK4.82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-184MINERAL SUNSCREEN LIP BALM SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [ARUBA ALOE BALM NV]2Legacy NDC, 1 package rows20231108_ac87fe83-dd4c-44c8-9ad8-3416fa88d71e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-184-17536750184174.8 g in 1 APPLICATOR (53675-184-17) 4.8 g2019-01-050000-00-00NoNoCurrent