FDA.reportPublic FDA data

Sun Shades Lip Balm

Product NDC
54473-226
11-digit product format
544730226
Labeler code
54473
Product ID
54473-226_4747c8ff-53eb-ef14-e063-6294a90ae4e0
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
Pina Colada
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
16d0d2d2-b9c4-4491-8d8a-815843d342e8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-226-042020-03-19C16284748780-19d75b9d0-7def-f424-e053-dadaa90a57ceSun Shades Lip Balm - Sunscreen Pina Colada - Broad-spectrum SPF 15
54473-226-042020-01-31C16284748780-19d75b9d0-7def-f424-e053-dadaa90a57ceSun Shades Lip Balm - Sunscreen Pina Colada - Broad-spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-226-04Sun Shades Lip BalmPina Colada4.25 g in 1 TUBESTICK4.257

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
AVOBENZONEACTIVE MOIETYG63QQF2NOXSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
AMMONIUM GLYCYRRHIZATEINACTIVE INGREDIENT3VRD35U26CSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
CERESININACTIVE INGREDIENTQ1LS2UJO3ASUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)INACTIVE INGREDIENTL5F16ZG4ZUSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
JOJOBA OILINACTIVE INGREDIENT724GKU717MSUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VSUN SHADES LIP BALM PINA COLADA (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
54473-226SUN SHADES LIP BALM PINA COLADA (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.]6Current NDC, Legacy NDC, 1 package rows20240918_16d0d2d2-b9c4-4491-8d8a-815843d342e8.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 2 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
application number: M020
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
application number: M020
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
application number: M020
Jack Black Sun Guard Sunscreen SPF45SUNSCREENJack Black, LLC3cc86bb2-05ce-47eb-8c71-f4f116ca58402026-09-08WarningsExact identifier
application number: M020
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
application number: M020
Jack Black Lavender Lip Balm 0.25ozLIP BALM SUNSCREENJack Black, L.L.C.e8c6a6d9-1093-41f1-87d5-faf8583d43192026-09-08WarningsExact identifier
application number: M020
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8695305-b89d-c21c-e053-6394a90a0e842026-09-08WarningsExact identifier
application number: M020
Sunscreen stickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.e9f963ee-a98c-efc1-e053-2a95a90aaf532026-09-08WarningsExact identifier
application number: M020
SPF30 Sunscreen 01AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5b04751d-32e9-a7e2-e063-6294a90aefbd2026-09-08WarningsExact identifier
application number: M020
Juyasuyon Invisible SunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONEGuangdong Aimu Biological Technology Co., Ltd5ab335b5-bb9e-4642-e063-6294a90a39862026-09-05WarningsExact identifier
application number: M020
No7 Future Renew Defense Shield SPF 50AVOBENZONE, OCTINOXATE, OCTISALATEBCMC41cc2c52-c6a4-611c-e063-6294a90aae012026-09-03WarningsExact identifier
application number: M020
WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALMART, INC.58b5d0ce-9157-9dee-e063-6394a90ab5432026-09-02WarningsExact identifier
application number: M020
Chantecaille Ultra Sun Protection Sunscreen SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEChantecaille Beaute Inc6186ea56-7d56-43f5-985d-a012f1296afa2026-09-02WarningsExact identifier
application number: M020
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50AVOBENZONE, BEMOTRIZINOL, OCTISALATEGrace and Fire USA5739c5b9-00d8-75a8-e063-6394a90aa8c72026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC2d5fa597-08a8-41ca-ba9e-b52e41a5c70c2026-09-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-226-04544730226044.25 g in 1 TUBE (54473-226-04) 4.25 g2018-01-010000-00-00NoNoCurrent