Aruba Aloe SPF 50 Mineral Sunscreen

Product NDC: 53675-194
11-digit product format: 536750194
Labeler code: 53675
Product ID: 53675-194_d8284b18-33a7-7f40-e053-2a95a90a51e8
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: 2022-01-20
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 100 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53675-194		D	Discontinued by firm		2026-10-05
excluded package	package	53675-194	53675-194-01	D	Discontinued by firm		2026-10-05

Adverse event summaries are temporarily unavailable. Other product information remains available.

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53675-194-01	Aruba Aloe SPF 50 Mineral Sunscreen	177 mL in 1 TUBE	CREAM	177		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53675-194	ARUBA ALOE SPF 50 MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ARUBA ALOE BALM NV]	2	Legacy NDC, 1 package rows	20231108_d8283ab0-b3e1-e4a0-e053-2a95a90a7cae.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53675-194-01	53675019401	177 mL in 1 TUBE (53675-194-01)	177 ml	2022-01-20	0000-00-00	No	No	Current