Home NDC 84066-103 SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15
Product NDC 84066-103
11-digit product format 840660103
Labeler code 84066
Product ID 84066-103_46871df7-0e77-a3c4-e063-6394a90a82c5
Type HUMAN OTC DRUG
Nonproprietary name Ethylhexyl Methoxycinnamate, Octocrylene
Dosage form GEL
Route TOPICAL
Labeler Guangzhou Tata Biotechnology Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-02
Substance OCTINOXATE; OCTOCRYLENE
Active strength 7.5; 5 mg/100mL; mg/100mL
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 SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 7.5 mg/100mL OCTOCRYLENE 5 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 5A68WGF6WM Internal UNII lookup
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 84066-103-01 SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15 10 mL in 1 TUBE GEL 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84066-103 SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15 (ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE) GEL [GUANGZHOU TATA BIOTECHNOLOGY CO., LTD.] 2 Current NDC, 1 package rows 20240723_1c32b019-a038-eb61-e063-6394a90a45f2.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 84066-103-01 84066010301 10 mL in 1 TUBE (84066-103-01) 10 ml 2024-07-02 No No Current