Home NDC 65912-003 Daily Defence Shield
Product NDC 65912-003
11-digit product format 659120003
Labeler code 65912
Product ID 65912-003_43f52c86-6ac3-110e-e063-6394a90a0d4a
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, OCTINOXATE, and OCTOCRYLENE
Dosage form CREAM
Route TOPICAL
Labeler ELEMIS Limited
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-06-04
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength 14; 14; 7 mg/g; mg/g; mg/g
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 Daily Defence Shield
Brand name suffix SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 14 mg/g OCTINOXATE 14 mg/g OCTOCRYLENE 7 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4Y5P7MUD51 Internal UNII lookup 5A68WGF6WM Internal UNII lookup
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 65912-003-41 Daily Defence ShieldSPF 30 1 in 1 CARTON CREAM 1 8 65912-003-41 Daily Defence ShieldSPF 30 40 g in 1 TUBE CREAM 40 8 65912-003-43 Daily Defence ShieldSPF 30 40 g in 1 TUBE CREAM 40 8 65912-003-52 Daily Defence ShieldSPF 30 40 g in 1 TUBE CREAM 40 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65912-003 DAILY DEFENCE SHIELD SPF 30 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) CREAM [ELEMIS LIMITED] 7 Current NDC, Legacy NDC, 4 package rows 20241215_b2b6de93-47c8-4b6e-9fb9-8bdc8909271a.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 65912-003-41 65912000341 1 TUBE in 1 CARTON (65912-003-41) / 40 g in 1 TUBE 1 tube 2018-06-04 0000-00-00 No No Current 65912-003-43 65912000343 40 g in 1 TUBE (65912-003-43) 40 g 2018-06-04 0000-00-00 No No Current 65912-003-52 65912000352 40 g in 1 TUBE (65912-003-52) 40 g 2018-06-04 0000-00-00 Yes No Current