Home NDC 67879-309 SUN THERAPE FACE AND BODY
Product NDC 67879-309
11-digit product format 678790309
Labeler code 67879
Product ID 67879-309_1f947bfc-53ab-1cbe-e063-6294a90aebb1
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form LOTION
Route TOPICAL
Labeler PHARMAGEL INTERNATIONAL INC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-06-18
Substance OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE
Active strength 7.5; 5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 SUN THERAPE FACE AND BODY
Brand name suffix SPF-35
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 7.5 g/100mL OCTISALATE 5 g/100mL OXYBENZONE 3 g/100mL AVOBENZONE 3 g/100mL
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67879-309-12 SUN THERAPE FACE AND BODYSPF-35 125 mL in 1 TUBE LOTION 125 8 67879-309-51 SUN THERAPE FACE AND BODYSPF-35 1 in 1 BOX LOTION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67879-309 SUN THERAPE FACE AND BODY SPF-35 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [PHARMAGEL INTERNATIONAL INC] 8 Current NDC, Legacy NDC, 2 package rows 20240815_6a96623f-c37c-4e67-925e-f133461d726d.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 Marketing end Sample Exclude flag Status 67879-309-12 67879030912 125 mL in 1 TUBE 125 ml Historical 67879-309-51 67879030951 1 TUBE in 1 BOX (67879-309-51) / 125 mL in 1 TUBE (67879-309-12) 1 tube 2016-06-10 0000-00-00 No No Current