Sun Shades Lip Balm

Product NDC
54473-220
11-digit product format
544730220
Labeler code
54473
Product ID
54473-220_4747d1b9-2380-b493-e063-6394a90a79e5
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
2013-02-01
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
Mountain Mint
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
54473-220-01Sun Shades Lip BalmMountain Mint4.25 g in 1 APPLICATORSTICK4.259

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
AVOBENZONEACTIVE MOIETYG63QQF2NOXSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
OXYBENZONEACTIVE MOIETY95OOS7VE0YSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19SUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
CERESININACTIVE INGREDIENTQ1LS2UJO3ASUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)INACTIVE INGREDIENTL5F16ZG4ZUSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
JOJOBA OILINACTIVE INGREDIENT724GKU717MSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VSUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-220SUN SHADES LIP BALM MOUNTAIN MINT (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]8Current NDC, Legacy NDC, 1 package rows20240918_326d9623-0e67-43bd-83f8-ee7dfa3bdbe8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-220-01544730220014.25 g in 1 APPLICATOR (54473-220-01) 4.25 g2018-01-010000-00-00NoNoCurrent