FDA.reportPublic FDA data

natural lip balm SPF15( chocolate sundae)

Product NDC
82953-044
11-digit product format
829530044
Labeler code
82953
Product ID
82953-044_319e6adb-5c16-2775-e063-6294a90a4fd2
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Homosalate,Octocrylene,Octisalate
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-27
Substance
OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength
3; 5; 2; 3 g/100g; g/100g; g/100g; g/100g
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
natural lip balm SPF15( chocolate sundae)
Brand name suffix
01
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE3 g/100g
HOMOSALATE5 g/100g
AVOBENZONE2 g/100g
OCTISALATE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
319e8e26-b29d-4627-e063-6294a90acfbaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-044-01natural lip balm SPF15( chocolate sundae)014.5 g in 1 CYLINDERLIPSTICK4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-044NATURAL LIP BALM SPF15( CHOCOLATE SUNDAE) 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) LIPSTICK [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 1 package rows20250402_319e8e26-b29d-4627-e063-6294a90acfba.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 281 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Sun Town City SPF 15 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7aaa185-8490-60ec-e053-2995a90adc0d2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Dark Tanning SPF 8 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7aa1e58-f7b3-6b7f-e053-2995a90a957c2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7bbad46-5c52-9f1d-e053-2995a90ae1392024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7bdd7a3-2e88-d881-e053-2a95a90a2ef92024-10-17WarningsExact identifier
application number: M020
dermalogica dynamic skin recovery spf 50SUNSCREENDermalogica, LLC051b77ab-6970-48e4-bbfd-c066178ea32e2024-10-17WarningsExact identifier
application number: M020
Hyaluronic MoisturizerOCTINOXATE, OXYBENZONE. AVOBENZONEBentley Laboratories LLC88bd6dff-ba19-4f8f-9432-28398d24f1ab2024-10-16WarningsExact identifier
application number: M020
EQUALINE SPORT CONTINUOUS SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf13feba4-25d8-61d0-e053-2995a90aafa82024-10-16WarningsExact identifier
application number: M020
Equaline Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf0dda684-b0ed-629c-e053-2995a90a12872024-10-16WarningsExact identifier
application number: M020
EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIe46d20b3-2897-1370-e053-2a95a90a619c2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISLATE, OCTOCRYLENEMEIJER DISTRIBUTION. INC.a71d34d4-a924-6421-e053-2995a90a647e2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMEIJER DISTRIBUTION, INC.a71bf24f-b923-b81f-e053-2995a90a00722024-10-16WarningsExact identifier
application number: M020
MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDEMEIJER DISTRIBUTION INCa9f4fd45-3bbb-14a7-e053-2995a90ab28f2024-10-16WarningsExact identifier
application number: M020
WEGMANS SPORT CLEAR CONTINUOUS SUNSCREEN SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCe4b7df52-2bc9-1afc-e053-2a95a90a4f872024-10-16WarningsExact identifier
application number: M020
Wegmans SPORT BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf12bff9a-bd3c-e35d-e053-2995a90abf172024-10-16WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDEWEGMANS FOOD MARKETS INCbfe24f55-d0e5-254a-e053-2995a90a2fd32024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Broad Spectrum SPF 70 Clear Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWEGMANS FOOD MARKETS INCe7175821-e514-1bea-e053-2995a90a0c0d2024-10-16WarningsExact identifier
application number: M020
Wegmans Kids and Sport Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf3463f81-9a65-3796-e053-2995a90a4f802024-10-16WarningsExact identifier
application number: M020
Wegmans Sheer Broad Spectrum SPF 30 Dry Touch SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf33248fa-695a-fbef-e053-2a95a90abe352024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf5671251-e26b-045f-e053-2a95a90adc032024-10-16WarningsExact identifier
application number: M020
Wegmans Kids Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf57775c3-5e6c-f47a-e053-2a95a90ab0122024-10-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-044-01829530044014.5 g in 1 CYLINDER (82953-044-01) 4.5 g2025-03-27NoNoCurrent