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

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
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 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
2037cc9d-b11b-47d6-8d65-c0f9decc8ba7Available on FDA.report

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

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 3 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7e48a3d2-e453-4733-b42b-8bea804cda592026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7204c24f-aab6-45eb-9bd4-879f715ba0752026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7c1e780a-1831-4f49-a92e-e36017d241a22026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCd45614c8-b09c-417b-b691-082ea21498802026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC999b0b17-be73-4d42-b182-ce038f4933012026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCadffff46-4cfb-4c0a-b1a6-75220ee193a52026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC13b2b45b-70e1-46ff-8555-48e1fe98c6512026-09-01WarningsExact identifier
application number: M020
Sun Wave Kids Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC5c2a5ca3-e9eb-48ba-8698-592d2c7aa2412026-09-01WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UVBUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECraver Corporation38d8c1c9-86b5-1edd-e063-6394a90aeb472026-08-30WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a3a17ff-a7fd-f707-e063-6394a90a31822026-08-29WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.f5eb347f-0d46-4de6-8f3f-9010327678ed2026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
application number: M020
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a02c540-5b3b-9379-e063-6294a90a00f62026-08-27WarningsExact identifier
application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
application number: M020

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