Home NDC 65912-012 PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50
Product NDC 65912-012
11-digit product format 659120012
Labeler code 65912
Product ID 65912-012_440ead21-3238-12ec-e063-6394a90a4acb
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form CREAM
Route TOPICAL
Labeler Elemis Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 3; 5; 5; 7 mg/100g; mg/100g; mg/100g; mg/100g
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 PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 mg/100g HOMOSALATE 5 mg/100g OCTISALATE 5 mg/100g OCTOCRYLENE 7 mg/100g
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 65912-012-40 PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50 1 in 1 CARTON CREAM 1 2 65912-012-40 PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50 40 g in 1 TUBE CREAM 40 2 65912-012-41 PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50 40 g in 1 TUBE CREAM 40 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65912-012 PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) CREAM [ELEMIS LTD.] 1 Current NDC, 3 package rows 20250101_23f9222f-60ba-72fb-e063-6394a90a9965.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 65912-012-40 65912001240 1 TUBE in 1 CARTON (65912-012-40) / 40 g in 1 TUBE 1 tube 2025-01-01 No No Current 65912-012-41 65912001241 40 g in 1 TUBE (65912-012-41) 40 g 2025-01-01 No No Current