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 280 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Market Basket Continuous Sunscreen General Protection SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEDEMOULAS SUPER MARKETS, INC.e7182d07-a006-db4b-e053-2995a90aa9e12024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467df80-9007-46c9-e053-2a95a90a1bef2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT KIDS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467c306-a2ed-4976-e053-2995a90a56ed2024-10-17WarningsExact identifier
application number: M020
Exchange Select Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEArmy & Air Force Exchange Servicee716ba8c-0148-07f2-e053-2a95a90a53df2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicef55828b4-f2a4-13ec-e053-2995a90a0f842024-10-17WarningsExact identifier
application number: M020
SPF50 Plus Mineral SunscreenZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanics08e8bc10-85d8-4215-8351-7ec12029416c2024-10-17WarningsExact identifier
application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLC9ac92c96-5bcf-421d-9cd0-73ddfa10195c2024-10-17WarningsExact identifier
application number: M020
bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance FreeOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLC20b32aae-7f8b-44ed-a3df-706054fd68832024-10-17WarningsExact identifier
application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLCd77be4d0-c08a-4d81-b5df-a9bae38e3b972024-10-17WarningsExact identifier
application number: M020
FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREENHOMOSALATE, OCTISALATEFRUIT OF THE EARTH, INC.13325a2a-f7f8-4019-acbb-205fd5dd13a52024-10-17WarningsExact identifier
application number: M020
FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTOCRYLENEFRUIT OF THE EARTH, INC.ae7951e9-54f6-4eab-81b6-a2b2c978851d2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Cabana Beach Clubwith Blood Orange and Essential Oils SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7805f3c-5b95-73bd-e053-2a95a90a99842024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Cabana Beach Club with Manuka Honey and Essential Oils SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7820ba9-7520-5139-e053-2a95a90ab92d2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Cabana Beach Club with Blood Orange and Essential Oils SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEFruit of the Earth, Inc.c7916317-c6a2-2eda-e053-2995a90a16282024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Cabana Beach Club with Mentha and Essential Oils SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c790031d-5448-a998-e053-2a95a90a763e2024-10-17WarningsExact identifier
application number: M020
Fruit of The Earth Sun Town City Kids SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c79472ea-a367-1328-e053-2a95a90a22d52024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Dark Tanning Dry Oil SPF 8 SunscreenHOMOSALATE, OCTISALATEFruit of the Earth, Inc.c7a94f68-a4d5-ec82-e053-2995a90a38fb2024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7ba72c2-ea23-0bb9-e053-2a95a90a1d902024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEFruit of the Earth, Inc.c795cd2f-89dc-78e3-e053-2a95a90a94222024-10-17WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c7a4783f-477f-1524-e053-2995a90a5ad92024-10-17WarningsExact 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