Home NDC 68605-8640 Pro-Tect Sports Sunscreen SPF 20
Product NDC 68605-8640
11-digit product format 686058640
Labeler code 68605
Product ID 68605-8640_5ad6f8f7-a816-4270-9d5b-f908b94a746c
Type HUMAN OTC DRUG
Nonproprietary name Meradimate, Octinoxate, Octisalate, Oxybenzone
Dosage form LOTION
Route CUTANEOUS
Labeler ABBE Laboratories, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-01
Substance OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE
Active strength 75; 50; 30; 50 mg/g; mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-Tect Sports Sunscreen SPF 20
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 75 mg/g MERADIMATE 50 mg/g OXYBENZONE 30 mg/g OCTISALATE 50 mg/g
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68605-8640-2 Pro-Tect Sports Sunscreen SPF 20 907.2 g in 1 BOTTLE, PLASTIC LOTION 907.2 5 68605-8640-4 Pro-Tect Sports Sunscreen SPF 20 113.4 g in 1 BOTTLE, PLASTIC LOTION 113.4 5 68605-8640-8 Pro-Tect Sports Sunscreen SPF 20 226.8 g in 1 BOTTLE, PLASTIC LOTION 226.8 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68605-8640 PRO-TECT SPORTS SUNSCREEN SPF 20 (MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [ABBE LABORATORIES, INC.] 3 Current NDC, Legacy NDC, 3 package rows 20250213_35869e8d-8e48-4b22-8af3-6964fe8ac182.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 68605-8640-2 68605864002 907.2 g in 1 BOTTLE, PLASTIC (68605-8640-2) 907.2 g 2022-05-01 0000-00-00 No No Current 68605-8640-4 68605864004 113.4 g in 1 BOTTLE, PLASTIC (68605-8640-4) 113.4 g 2022-05-01 0000-00-00 No No Current 68605-8640-8 68605864008 226.8 g in 1 BOTTLE, PLASTIC (68605-8640-8) 226.8 g 2022-05-01 0000-00-00 No No Current