FDA.reportPublic FDA data

Sun Shades Lip Balm

Product NDC
54473-219
11-digit product format
544730219
Labeler code
54473
Product ID
54473-219_4747dd7a-f696-e18e-e063-6394a90a46c3
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
Vanilla Bean
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-219-042020-03-19C16284748780-19d75b9cf-f998-f424-e053-dadaa90a57ceSun Shades Lip Balm - Sunscreen Vanilla Bean - Broad-spectrum SPF 15
54473-219-042020-01-31C16284748780-19d75b9cf-f998-f424-e053-dadaa90a57ceSun Shades Lip Balm - Sunscreen Vanilla Bean - Broad-spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-219-04Sun Shades Lip BalmVanilla Bean4.25 g in 1 APPLICATORSTICK4.258

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
AVOBENZONEACTIVE MOIETYG63QQF2NOXSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19SUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
CERESININACTIVE INGREDIENTQ1LS2UJO3ASUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)INACTIVE INGREDIENTL5F16ZG4ZUSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
JOJOBA OILINACTIVE INGREDIENT724GKU717MSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VSUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-219SUN SHADES LIP BALM VANILLA BEAN (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]7Current NDC, Legacy NDC, 1 package rows20240918_2037cc9d-b11b-47d6-8d65-c0f9decc8ba7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-219-04544730219044.25 g in 1 APPLICATOR (54473-219-04) 4.25 g2018-01-010000-00-00NoNoCurrent