FDA.reportPublic FDA data

SUNSCREEN LIP BALM

Product NDC
84066-101
11-digit product format
840660101
Labeler code
84066
Product ID
84066-101_4686f9b1-07a5-74cc-e063-6394a90a3afa
Type
HUMAN OTC DRUG
Nonproprietary name
Ethylhexyl Methoxycinnamate, Homosalate, Polysilicone-15, Octocrylene, Butyl Methoxydibenzoylmethane
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Guangzhou Tata Biotechnology Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-25
Substance
POLYSILICONE-15; OCTOCRYLENE; OCTINOXATE; HOMOSALATE; AVOBENZONE
Active strength
5; 5; 7; 6; 2 g/100g; 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
SUNSCREEN LIP BALM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYSILICONE-155 g/100g
OCTOCRYLENE5 g/100g
OCTINOXATE7 g/100g
HOMOSALATE6 g/100g
AVOBENZONE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F8DRP5BB29Internal UNII lookup
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f8e08bf-4b14-bdad-e063-6394a90a34e1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84066-101-01SUNSCREEN LIP BALM3.2 g in 1 TUBELIPSTICK3.25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84066-101SUNSCREEN LIP BALM (ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE) LIPSTICK [GUANGZHOU TATA BIOTECHNOLOGY CO., LTD.]3Current NDC, 1 package rows20240706_0f8e08bf-4b14-bdad-e063-6394a90a34e1.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 235 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Meet Your Flawless Matte Skin DuoOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDESocoplan3541c41b-f114-4734-a66f-be309ca6f3bf2025-01-16WarningsExact identifier
application number: M020
SUNSTATION USA SPF-30 SPORT SUNSCREEN-SUNSTATION USA SPF-30 SPORT SUNSCREEN-Sunstation USA, LLC2bd84b92-dcf0-404f-e063-6294a90a10602025-01-16Exact identifier
application number: M020
Snap On Racing Sunscreen KitAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGreater Pacific Industries, Inc.9f4f91d0-0fc5-43a3-be79-afce5afa2f952025-01-16WarningsExact identifier
application number: M020
Emme Diane Pure Protection Tinted Antioxidant SunscreenZINC OXIDEEmme Diane, Inc.b2b4daf5-765b-426d-8a72-9278f7cd43d72025-01-16WarningsExact identifier
application number: M020
Emme Diane Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEmme Diane, Incab53ad98-b667-4447-8177-724dbf771e802025-01-16WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
application number: M020
Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40ZINC OXIDESUNNY SAILOR LLC14ea2d11-c425-45d8-a23a-d4ed82a6439c2025-01-15WarningsExact identifier
application number: M020
glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30GLO SKIN BEAUTY OIL-FREE TINTED PRIMER SPF 30Hayden Caleel LLC00bf7331-c9dc-4a8a-9ff3-901e0d07eac62025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc42f6f-4eaf-fa28-e063-6294a90a93fb2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEBlack Girl Sunscreen, LLC2bc419b3-4de2-7ed9-e063-6394a90a255f2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc47bd0-d81b-f1b9-e063-6394a90ad3752025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50OCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONEBlack Girl Sunscreen, LLC2bc46854-fe67-782b-e063-6294a90a79af2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATEBlack Girl Sunscreen, LLC2bc471f0-c93e-0c51-e063-6394a90a77f02025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4b1b1-5f19-7ba3-e063-6394a90a5de72025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4c639-787a-d2d3-e063-6394a90a5ded2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4d937-77d0-273c-e063-6394a90a25e72025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4cfd9-e44c-9b93-e063-6394a90a96a62025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4e22d-6265-9c0b-e063-6394a90a15412025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4eb32-8c0b-32fc-e063-6294a90a16252025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc50182-30f2-b77e-e063-6394a90a63552025-01-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84066-101-01840660101013.2 g in 1 TUBE (84066-101-01) 3.2 g2024-01-25NoNoCurrent