Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection

Product NDC
53675-165
Requested package NDC
53675-165-00
11-digit product format
536750165
Labeler code
53675
Product ID
53675-165_5fc8ccf5-f578-048e-e053-2a91aa0a6263
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-06-10
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
30 mg/mL; mg/mL; mg/mL; mg/mL; 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 packagepackage53675-16553675-165-00DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-165-00Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection59 mL in 1 TUBECREAM594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-165SUNSCREEN SPF 50 PLUS BROAD SPECTRUM UVA UVB PROTECTION (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) CREAM [ARUBA ALOE BALM NV]3Legacy NDC, 1 package rows20231108_1068ef02-983a-49be-89b2-0ec33fa369e1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-165-005367501650059 mL in 1 TUBE (53675-165-00) 59 ml2017-06-100000-00-00NoNoCurrent