FDA.reportPublic FDA data

natural lip balm SPF15( Cocount Pina Colada)

Product NDC
82953-034
Requested package NDC
82953-034-01
11-digit product format
829530034
Labeler code
82953
Product ID
82953-034_31539713-cf4f-cc55-e063-6394a90a28c8
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( Cocount Pina Colada)
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
31538f32-9f71-bd40-e063-6394a90a1cd8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-034-01natural lip balm SPF15( Cocount Pina Colada)014.5 g in 1 CYLINDERLIPSTICK4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-034NATURAL LIP BALM SPF15( COCOUNT PINA COLADA) 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) LIPSTICK [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 1 package rows20250328_31538f32-9f71-bd40-e063-6394a90a1cd8.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 209 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfecting BB Beauty Balm Natural Tint SPF 30ZINC OXIDEAndalou naturals16ca3790-9973-4a04-a43c-e0f7b384f1472025-06-11WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd.3690af2b-fe22-3a9a-e063-6294a90a709d2025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEPPacifica Beauty, LLC373901f7-0e32-0f32-e063-6394a90abe252025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TANPacifica Beauty, LLC37397b96-ef14-9098-e063-6294a90aafc92025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHTPacifica Beauty, LLC373aba7c-2ae1-8726-e063-6294a90ae3d82025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUMPacifica Beauty, LLC373c29b9-2f75-9777-e063-6394a90a68a62025-06-10WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374395ea-ab91-de70-e063-6394a90aec562025-06-10WarningsExact identifier
application number: M020
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30ZINC OXIDEAndalou naturalsaa689e82-6512-46d8-aec9-269f9348d3f82025-06-09WarningsExact identifier
application number: M020
ALLIES OF SKIN The One SPF-50 Invisible SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.36e1c61c-33ab-4a5d-853d-119c29632b082025-06-09WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTION STITANIUM DIOXIDE AND ZINC OXIDEShiseido Americas Corporationb2fae1ba-67fe-48ef-b31f-62db343499612025-06-09WarningsExact identifier
application number: M020
Olay Super Cream with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company372819f1-0813-2cd5-e063-6294a90ac5bf2025-06-09WarningsExact identifier
application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-ClearAVOBENZONE, HOMOSALATE, OCTISALATEe.l.f. Cosmetics, Inc.3806e2f2-ffd1-6d69-e063-6394a90acb442025-06-09WarningsExact identifier
application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-GetawayAVOBENZONE, HOMOSALATE, OCTISALATEe.l.f. Cosmetics, Inc.3808613f-88d6-6c1a-e063-6294a90a5bb22025-06-09WarningsExact identifier
application number: M020
1000 Roses Daily Shade Facial SPF 18OCTISALATE, OCTOCRYLENE, AND AVOBENZONEAndalou naturals0923e090-6834-4373-80fe-21f00b8c1c172025-06-09WarningsExact identifier
application number: M020
dAlba Vegan Fresh Sun CushionZINC OXIDE, HOMOSALATE, OCTOCRYLENEADMTMAX LLC20afcbab-a2f4-7965-e063-6294a90a83d12025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Mild SunscreenZINC OXIDEADMTMAX LLC20ab5698-cd9f-0821-e063-6394a90a60d72025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Fresh Sun StickHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATEADMTMAX LLC20ae82ae-bc8f-89d1-e063-6394a90afff22025-06-08WarningsExact identifier
application number: M020
dAlba Vegan Essence SunscreenHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATEADMTMAX LLC1ccfa213-2f83-ad50-e063-6294a90a38bf2025-06-08WarningsExact identifier
application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/MediumZINC OXIDEPacifica Beauty, LLC36ec6c9d-f7dc-0419-e063-6294a90a55e62025-06-06WarningsExact identifier
application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/FairZINC OXIDEPacifica Beauty, LLC36ed9101-249a-922c-e063-6394a90a26082025-06-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-034-01829530034014.5 g in 1 CYLINDER (82953-034-01) 4.5 g2025-03-27NoNoCurrent