Sun Shades Lip Balm

Product NDC
54473-223
11-digit product format
544730223
Labeler code
54473
Product ID
54473-223_30ce1c87-335a-f0ee-e063-6394a90a01d5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
Dosage form
STICK
Route
TOPICAL
Labeler
Melaleuca Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-31
Substance
AVOBENZONE; OCTINOXATE; OXYBENZONE
Active strength
.1175; .282; .141 g/4.25g; g/4.25g; g/4.25g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sun Shades Lip Balm
Brand name suffix
Cranberry Tangerine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE.1175 g/4.25g
OCTINOXATE.282 g/4.25g
OXYBENZONE.141 g/4.25g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 4Y5P7MUD51, 95OOS7VE0Y

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-223-01Sun Shades Lip BalmCranberry Tangerine4.25 g in 1 TUBESTICK4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-223SUN SHADES LIP BALM CRANBERRY TANGERINE (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2Current NDC, 1 package rows20250409_f39606be-19c8-58d1-e053-2a95a90a908f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54473-223-01544730223014.25 g in 1 TUBE (54473-223-01) 4.25 g2023-01-31NoNoHistorical