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 56 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.14b9ec0e-6fff-44b1-e063-6394a90aab972026-03-05WarningsExact identifier
application number: M020
belif Aqua bomb - glow sunstick SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.4c35fbbc-a79d-318f-e063-6394a90a30a72026-03-04WarningsExact identifier
application number: M020
Kids Mineral Sunscreen Stick SPF 50ZINC OXIDESmalls Brand LLC DBA Roe Wellness4c37855b-08c0-0aa7-e063-6394a90a88422026-03-04WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Incbe03b588-afbd-41d1-be96-444d735c97682026-03-03WarningsExact identifier
application number: M020
UNME SOULMA CENTELLA and BEEF TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ZINC OXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACIDShenzhen Jufeng Qiyuan Trading Co., Ltd.4c1a3345-58c1-93c8-e063-6394a90a865e2026-03-03WarningsExact identifier
application number: M020
Botnia Gentle Sun SPF 30ZINC OXIDEBotnia, Inc005d0245-fe53-47e5-888b-683f58cd6d262026-03-03WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.64534ec3-396c-4c11-9ec1-e2615f7e24b12026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.9b7249e4-4c1f-40e7-a657-d40c53d9317f2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenSUNSCREENOld East Main Co.1673b8b1-08ad-40a5-8180-93333a8edb672026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.32036e41-2414-4498-8e1c-61511abf7a322026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 100AVOBENZONE HOMOSALATE OCTISALATEOld East Main Co.42266fa5-5f30-2a9f-e063-6394a90a1dfe2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAmazon.com Services LLCd4b4ebac-c6c2-474b-afc6-b80b8431e90f2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Fruit Snack SPF 15 Broad Spectrum Lip BalmFRUIT SNACK SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc24c2a9fc-892b-c74d-e063-6394a90af62c2026-03-03WarningsExact identifier
application number: M020
Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4c231aa1-75eb-c171-e063-6294a90a8b8b2026-03-03WarningsExact identifier
application number: M020
SPF 30 Mineral SunscreenZINC OXIDESmalls Brand LLC DBA Roe Wellness4c25b4ec-b045-7066-e063-6294a90ab8012026-03-03WarningsExact identifier
application number: M020
Good Weather Skin Daily Lip Sun Gloss SPF 30 Iced CoffeeZINC OXIDEGood Weather Inc.4c261e88-7f37-2361-e063-6294a90aa6022026-03-03WarningsExact identifier
application number: M020
Good Weather Skin All Over Sun Milk Face and Body SPF 50ZINC OXIDEGood Weather Inc.4c278acc-7cd5-0d85-e063-6394a90a3a722026-03-03WarningsExact identifier
application number: M020
Lekura - ZincDaily Natural Face Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4c2bed23-f77b-2c97-e063-6394a90a4ca52026-03-03WarningsExact identifier
application number: M020
NEOGEN DERMALOGY DAY-LIGHT PROTECTION AIRY SUNSCREEN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEOUTIN FUTURES CO.,LTD.4ddce1f0-44a3-7e0c-e063-6294a90a3f7d2026-03-03WarningsExact identifier
application number: M020
Bephor Reviving Suncream SPF50ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, ZINC OXIDEGyeongbuk Institute of IT Convergence Industry Technology4c055b22-94e9-ff0d-e063-6394a90ab2ec2026-03-02WarningsExact 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