FDA.reportPublic FDA data

Hylands Naturals Vanilla Sunscreen Lip Balm SPF 15

Product NDC
54973-4123
Requested package NDC
54973-4123-1
11-digit product format
549734123
Labeler code
54973
Product ID
54973-4123_49100eb3-33a0-4547-aeeb-b7a920932517
Type
HUMAN OTC DRUG
Nonproprietary name
Broad Spectrum SPF 15 Vanilla Lip Balm
Dosage form
STICK
Route
TOPICAL
Labeler
Hylands
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-18
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength
20 mg/g; mg/g; mg/g; mg/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54973-412354973-4123-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4123HYLANDS NATURALS VANILLA SUNSCREEN LIP BALM SPF 15 (BROAD SPECTRUM SPF 15 VANILLA LIP BALM) STICK [HYLANDS]2Legacy NDC20231104_fc5693f7-2785-4cda-89fb-8a9c17ea927d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-4123-1549734123014.25 g in 1 TUBE (54973-4123-1) 4.25 g2022-10-180000-00-00NoNoCurrent