Home NDC 65278-103 Intensive Age Defying Hydrating Complex SPF 25
Product NDC 65278-103
11-digit product format 652780103
Labeler code 65278
Product ID 65278-103_18f59d9d-1329-d815-e063-6294a90a3801
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octinoxate, Oxybenzone, Avobenzone
Dosage form CREAM
Route TOPICAL
Labeler June Jacobs Labs, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-10-23
Substance OCTINOXATE; AVOBENZONE; HOMOSALATE; OXYBENZONE
Active strength 3.549; 1.4196; 4.732; 2.366 g/47.32g; g/47.32g; g/47.32g; g/47.32g
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 Intensive Age Defying Hydrating Complex SPF 25
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 3.549 g/47.32g AVOBENZONE 1.4196 g/47.32g HOMOSALATE 4.732 g/47.32g OXYBENZONE 2.366 g/47.32g
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 65278-103-01 Intensive Age Defying Hydrating Complex SPF 25 47.32 g in 1 TUBE CREAM 47.32 1 65278-103-02 Intensive Age Defying Hydrating Complex SPF 25 47.32 g in 1 CARTON CREAM 47.32 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65278-103 INTENSIVE AGE DEFYING HYDRATING COMPLEX SPF 25 (HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE) CREAM [JUNE JACOBS LABS, LLC] 1 Current NDC, 2 package rows 20240530_18f59d9d-1328-d815-e063-6294a90a3801.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 65278-103-01 65278010301 47.32 g in 1 TUBE (65278-103-01) 47.32 g 2014-10-23 No No Current 65278-103-02 65278010302 47.32 g in 1 CARTON (65278-103-02) 47.32 g 2014-10-23 No No Current