Home NDC 84061-128 Australian Gold SPF 15 Lip Balm
Product NDC 84061-128
11-digit product format 840610128
Labeler code 84061
Product ID 84061-128_49020aaa-0208-4943-e063-6394a90abaef
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly
Dosage form STICK
Route TOPICAL
Labeler Australian Gold
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-01
Substance OCTINOXATE; OXYBENZONE; PETROLATUM; OCTOCRYLENE; OCTISALATE
Active strength 7.5; 5; 30; 7; 5 mg/g; mg/g; mg/g; mg/g; mg/g
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 Australian Gold SPF 15 Lip Balm
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 7.5 mg/g OXYBENZONE 5 mg/g PETROLATUM 30 mg/g OCTOCRYLENE 7 mg/g OCTISALATE 5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84061-128-01 Australian Gold SPF 15 Lip Balm 1 g in 1 CONTAINER STICK 1 1
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 84061-128-01 84061012801 1 g in 1 CONTAINER (84061-128-01) 1 g 2025-01-01 No No Current