FDA.reportPublic FDA data

Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL

Product NDC
81104-247
11-digit product format
811040247
Labeler code
81104
Product ID
81104-247_30f0ca37-f2be-da5f-e063-6294a90a1baa
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
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE3 g/100mL
OCTOCRYLENE10 g/100mL
AVOBENZONE5 g/100mL
OCTISALATE10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV06SV4M95S, 5A68WGF6WM, G63QQF2NOX, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81104-247-01Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL10 mL in 1 TUBE, WITH APPLICATORLIQUID103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81104-247NAKED SUNDAYS POUTSCREEN PLUMPING LIP TREATMENT CARAMEL LATTE 10ML (LIP TREATMENT) LIQUID [NAKED SUNDAYS PTY LTD]3Current NDC, 1 package rows20250402_2499e14a-c14f-ea13-e063-6394a90a62f5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81104-247-018110402470110 mL in 1 TUBE, WITH APPLICATOR (81104-247-01) 10 ml2024-10-16NoNoHistorical