Home NDC 83127-101 ARAMORE MULTI-DEFENSE SUNSCREEN - AM
Product NDC 83127-101
11-digit product format 831270101
Labeler code 83127
Product ID 83127-101_4849ec6e-9a24-c7aa-e063-6394a90a070d
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler New Frontier Bio, Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-12-09
Substance ZINC OXIDE
Active strength 20 g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS FOR EXTERNAL USE ONLY. DO NOT USE ON DAMAGED OR BROKEN SKIN. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF RASH OCCURS.
Additional Listing Data#
Finished product Yes
Brand name base ARAMORE MULTI-DEFENSE SUNSCREEN - AM
Brand name suffix Broad Spectrum SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 g/100mL
Harmonized Identifiers# Field, Values table Field Values Unii SOI2LOH54Z
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83127-101-11 ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 30 50 mL in 1 TUBE LOTION 50 4 83127-101-12 ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 30 1 in 1 BOX LOTION 1 4 83127-101-13 ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 30 15 mL in 1 TUBE LOTION 15 4 83127-101-14 ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 30 1 in 1 BOX LOTION 1 4 83127-101-15 ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 30 5 mL in 1 TUBE LOTION 5 4 83127-101-16 ARAMORE MULTI-DEFENSE SUNSCREEN - AMBroad Spectrum SPF 30 1 in 1 BOX LOTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83127-101 ARAMORE MULTI-DEFENSE SUNSCREEN - AM BROAD SPECTRUM SPF 30 (ZINC OXIDE) LOTION [NEW FRONTIER BIO, INC] 3 Current NDC, Legacy NDC, 6 package rows 20240202_ef6c8443-fd10-2022-e053-2a95a90a45ea.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83127-101-11 83127010111 50 mL in 1 TUBE (83127-101-11) 50 ml 2022-12-09 0000-00-00 No No Current 83127-101-12 83127010112 1 TUBE in 1 BOX (83127-101-12) / 50 mL in 1 TUBE (83127-101-11) 1 tube 2022-12-09 No No Current 83127-101-13 83127010113 15 mL in 1 TUBE 15 ml Historical 83127-101-14 83127010114 1 TUBE in 1 BOX (83127-101-14) / 15 mL in 1 TUBE (83127-101-13) 1 tube 2022-12-09 No No Current 83127-101-15 83127010115 5 mL in 1 TUBE 5 ml Historical 83127-101-16 83127010116 1 TUBE in 1 BOX (83127-101-16) / 5 mL in 1 TUBE (83127-101-15) 1 tube 2022-12-09 No No Current