FDA.reportPublic FDA data

Broad Spectrum Water Resistant SPF 50 Mineral Sunscreen Faces

Product NDC
53675-175
Requested package NDC
53675-175-00
11-digit product format
536750175
Labeler code
53675
Product ID
53675-175_5c77b15c-50a5-2e00-e053-2a91aa0aee50
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
2017-10-25
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53675-17553675-175-00DDiscontinued 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
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-175-00Broad Spectrum Water Resistant SPF 50 Mineral Sunscreen Faces59 mL in 1 TUBECREAM592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-175BROAD SPECTRUM WATER RESISTANT SPF 50 MINERAL SUNSCREEN FACES (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ARUBA ALOE BALM NV]2Legacy NDC, 1 package rows20231108_33b08cf2-2be4-4b22-b1f8-7649c0df241e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-175-005367501750059 mL in 1 TUBE (53675-175-00) 59 ml2017-10-250000-00-00NoNoCurrent