FDA.reportPublic FDA data

Broad Spectrum SPF 30 Water Resistant Mineral Sunscreen

Product NDC
53675-183
11-digit product format
536750183
Labeler code
53675
Product ID
53675-183_7ee43c86-0d48-d803-e053-2a91aa0a45dd
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
2019-01-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
100 mg/mL; mg/mL
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 productproduct53675-183DDiscontinued by firm2026-10-12
excluded packagepackage53675-18353675-183-30DDiscontinued 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
53675-183-30Broad Spectrum SPF 30 Water Resistant Mineral Sunscreen30 mL in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-183BROAD SPECTRUM SPF 30 WATER RESISTANT MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ARUBA ALOE BALM NV]3Legacy NDC, 1 package rows20231108_232f8af6-8fa5-4aee-be7a-40460c751ef6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-183-305367501833030 mL in 1 TUBE (53675-183-30) 30 ml2019-01-010000-00-00NoNoCurrent