Broad Spectrum SPF 50 Mineral Sunscreen

Product NDC
53675-189
11-digit product format
536750189
Labeler code
53675
Product ID
53675-189_098627cf-f8e3-2a19-e063-6394a90ab53f
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
100; 80 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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]2Current NDC, Legacy 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