Home NDC 65112-304 Sunplus SPF50 Face Body Sunscreen
Product NDC 65112-304
11-digit product format 651120304
Labeler code 65112
Product ID 65112-304_4a08871f-25e4-215d-e063-6394a90ab8a8
Type HUMAN OTC DRUG
Nonproprietary name Sunscreen
Dosage form LOTION
Route TOPICAL
Labeler I.Shay Cosmetics
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-06-01
Substance OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE
Active strength .06; .05; .02; .15 g/118mL; g/118mL; g/118mL; g/118mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sunplus SPF50 Face Body Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE .06 g/118mL OCTISALATE .05 g/118mL AVOBENZONE .02 g/118mL HOMOSALATE .15 g/118mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65112-304-01 Sunplus SPF50 Face Body Sunscreen 118 mL in 1 TUBE LOTION 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65112-304 SUNPLUS SPF50 FACE BODY SUNSCREEN (SUNSCREEN) LOTION [I.SHAY COSMETICS] 1 Current NDC, 1 package rows 20241115_26d55baf-66dc-b1b8-e063-6394a90a670d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65112-304-01 65112030401 118 mL in 1 TUBE (65112-304-01) 118 ml 2004-06-01 No No Current