FDA.reportPublic FDA data

natural lip balm SPF15( Passion Fruit)

Product NDC
82953-037
11-digit product format
829530037
Labeler code
82953
Product ID
82953-037_31543f86-c19d-19a4-e063-6394a90a43e6
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Homosalate,Octocrylene,Octisalate
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-27
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2; 5; 3; 3 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
natural lip balm SPF15( Passion Fruit)
Brand name suffix
01
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2 g/100g
HOMOSALATE5 g/100g
OCTISALATE3 g/100g
OCTOCRYLENE3 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-037-01natural lip balm SPF15( Passion Fruit)014.5 g in 1 CYLINDERLIPSTICK4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-037NATURAL LIP BALM SPF15( PASSION FRUIT) 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) LIPSTICK [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 1 package rows20250330_31544568-c556-72b2-e063-6294a90ace91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-037-01829530037014.5 g in 1 CYLINDER (82953-037-01) 4.5 g2025-03-27NoNoHistorical