Home NDC 81104-249 Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mL
Product NDC 81104-249
11-digit product format 811040249
Labeler code 81104
Product ID 81104-249_30f0e0ca-da7d-c9f6-e063-6294a90a62e7
Type HUMAN OTC DRUG
Nonproprietary name Lip Treatment
Dosage form LIQUID
Route TOPICAL
Labeler NAKED SUNDAYS PTY LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-16
Substance HOMOSALATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength 10; 10; 3; 5 g/100mL; g/100mL; g/100mL; g/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 Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 10 g/100mL OCTOCRYLENE 10 g/100mL AVOBENZONE 3 g/100mL OCTISALATE 5 g/100mL
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81104-249-01 Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mL 10 mL in 1 TUBE, WITH APPLICATOR LIQUID 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81104-249 NAKED SUNDAYS POUTSCREEN PLUMPING LIP TREATMENT MARSHMALLOW 10ML (LIP TREATMENT) LIQUID [NAKED SUNDAYS PTY LTD] 3 Current NDC, 1 package rows 20250402_24a98d3d-f830-9614-e063-6394a90aa7d1.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 81104-249-01 81104024901 10 mL in 1 TUBE, WITH APPLICATOR (81104-249-01) 10 ml 2024-10-16 No No Current