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 132 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373cef98-a61d-dd36-e063-6394a90a7c3b2025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373d1e6c-9c32-20f5-e063-6294a90af86f2025-12-11Exact identifier
application number: M020
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
application number: M020
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly TintedZINC OXIDENY BEAUTY PALACE LLC373ddad0-ed33-a233-e063-6294a90a19cd2025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37263083-b24f-5a71-e063-6294a90aee7d2025-12-11Exact identifier
application number: M020
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDESKINPLICITY STUDIO LLC37265b3d-92ef-ef4a-e063-6294a90a8d952025-12-11Exact identifier
application number: M020
Prevention BodyZINC OXIDENY BEAUTY PALACE LLC373d902f-f7b6-298b-e063-6394a90a93072025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726c177-2912-a6cc-e063-6394a90a00432025-12-11Exact identifier
application number: M020
Nourish And DefendZINC OXIDEANASTASIA FOX-TOMYLOVYCH3726f463-7e55-c2a2-e063-6394a90a3c512025-12-11Exact identifier
application number: M020
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37617bd5-c275-aeee-e063-6394a90a214d2025-12-11Exact identifier
application number: M020
Not YO 80s Zinc SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.37644dfd-e96d-a783-e063-6294a90a97962025-12-11Exact identifier
application number: M020
Not YO 80s Zinc SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.3762f132-4ab0-74ad-e063-6394a90a436c2025-12-11Exact identifier
application number: M020
GLOW UP Ageless Daily Protection SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.37637e45-c6ed-12ca-e063-6294a90aeb022025-12-11Exact identifier
application number: M020
Face and Body SunscreenZINC OXIDESCIENCE CEUTICALS, LLC369b42f3-5203-87c4-e063-6394a90a62842025-12-11Exact identifier
application number: M020
Nourish Non-Tinted Mineral SunscreenZINC OXIDEFern Burg34a32097-de93-9b1d-e063-6394a90a41df2025-12-11Exact identifier
application number: M020
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37641f8b-0133-8bfc-e063-6294a90aac5c2025-12-11Exact identifier
application number: M020
GLOW UP Ageless Daily Protection SunscreenZINC OXIDECLEAN SLATE SKIN & BODY, INC.3764856a-98c5-334e-e063-6394a90a629d2025-12-11Exact identifier
application number: M020
Essential Mineral Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEFern Burg34a360b2-6798-c7e8-e063-6294a90a5cbb2025-12-11Exact identifier
application number: M020
Nourish Non-Tinted Mineral SunscreenZINC OXIDEFern Burg34a3e268-e376-11a0-e063-6294a90a46af2025-12-11Exact 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