FDA.reportPublic FDA data

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
326d9623-0e67-43bd-83f8-ee7dfa3bdbe8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-220-012020-03-19C16284748780-19d75b9d0-d4e9-f424-e053-dadaa90a57ceSun Shades Lip Balm - Sunscreen Mountain Mint - Broad-spectrum SPF 15
54473-220-012020-01-31C16284748780-19d75b9d0-d4e9-f424-e053-dadaa90a57ceSun Shades Lip Balm - Sunscreen Mountain Mint - Broad-spectrum SPF 15

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral Body ShieldZINC OXIDEColorescience52e1f59e-63cb-7480-e063-6394a90ad7c52026-08-10WarningsExact identifier
application number: M020
Eucerin Radiant Tone Tinted Sunscreen SPF 50AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc596a4204-3d29-9023-e063-6294a90ad99e2026-08-10WarningsExact identifier
application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 SunscreenBEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDEGrace and Fire USA Inc.56ad0dce-410e-9d78-e063-6294a90a1c3e2026-08-09WarningsExact identifier
application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex SunscreenETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangzhou Yapheon Health Industry Co., Ltd.552a36ed-7a66-4048-e063-6394a90a09bc2026-08-08WarningsExact identifier
application number: M020
lip balm SPF15( 2533) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5870aa44-1375-cdc5-e063-6394a90af4a52026-08-07WarningsExact identifier
application number: M020
lip balm SPF15( Zinc oxide) 01ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.5871ab1d-cf07-d737-e063-6394a90a58fe2026-08-07WarningsExact identifier
application number: M020
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40ZINC OXIDECP Skin Health Group, Inc945538b5-5745-42cf-b610-0018ca2ec2542026-08-06WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
application number: M020
Stream2Sea Ecostock SPF 40 SunscreenZINC OXIDEStream2Sea, LLC5866e026-a652-3300-e063-6394a90acff02026-08-06WarningsExact identifier
application number: M020
NHLMA Skin Defense SunscreenBROAD SPECTRUM SPF 30NATIONAL HAIR LOSS LLC56326ae0-387f-ad08-e063-6294a90acc4f2026-08-06WarningsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
application number: M020
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
application number: M020

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