Home NDC 81104-596 PoutScreen Lip Treatment Midnight Kiss
Product NDC 81104-596
11-digit product format 811040596
Labeler code 81104
Product ID 81104-596_47d2360a-0b96-1e45-e063-6294a90a97ae
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octinoxate, Octocrylene
Dosage form LIQUID
Route TOPICAL
Labeler NAKED SUNDAYS PTY LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-18
Substance OCTINOXATE; AVOBENZONE; OCTOCRYLENE
Active strength 7.5; 2.5; 10 g/100mL; g/100mL; g/100mL
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 PoutScreen Lip Treatment Midnight Kiss
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 7.5 g/100mL AVOBENZONE 2.5 g/100mL OCTOCRYLENE 10 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 5A68WGF6WM Internal UNII lookup 4Y5P7MUD51 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 81104-596-01 PoutScreen Lip Treatment Midnight Kiss 15 mL in 1 TUBE, WITH APPLICATOR LIQUID 15 1 81104-596-02 PoutScreen Lip Treatment Midnight Kiss 1 in 1 CARTON LIQUID 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 128 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 81104-596-01 81104059601 15 mL in 1 TUBE, WITH APPLICATOR 15 ml Historical 81104-596-02 81104059602 1 TUBE, WITH APPLICATOR in 1 CARTON (81104-596-02) / 15 mL in 1 TUBE, WITH APPLICATOR (81104-596-01) 2025-12-18 No No Current