FDA.reportPublic FDA data

Broad Spectrum SPF 50 Mineral Sunscreen

Product NDC
53675-189
11-digit product format
536750189
Labeler code
53675
Product ID
53675-189_ab800863-b0bf-5821-e053-2a95a90a3144
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-15
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
100 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53675-189DDiscontinued by firm2026-10-16
excluded packagepackage53675-18953675-189-02DDiscontinued by firm2026-10-16
excluded packagepackage53675-18953675-189-06DDiscontinued 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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-189-02Broad Spectrum SPF 50 Mineral Sunscreen59 mL in 1 TUBECREAM592
53675-189-06Broad Spectrum SPF 50 Mineral Sunscreen177 mL in 1 TUBECREAM1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-189BROAD SPECTRUM SPF 50 MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ARUBA ALOE BALM NV]2Legacy NDC, 2 package rows20231108_9c7bc563-6c52-4ad2-8205-41e50b889f6b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-189-025367501890259 mL in 1 TUBE (53675-189-02) 59 ml2020-06-150000-00-00NoNoCurrent
53675-189-0653675018906177 mL in 1 TUBE (53675-189-06) 177 ml2020-06-150000-00-00NoNoCurrent