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 72 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY48e8b7f5-6977-bfae-e063-6394a90a888b2026-01-21WarningsExact identifier
application number: M020
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Gold32725ca7-ec21-4643-bdc6-278fd647b95d2026-01-21WarningsExact identifier
application number: M020
Australian Gold SPF 30 Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, PETROLATUMAustralian Golde6877f7a-3aaa-4096-bcb5-eae0aa2532e52026-01-21WarningsExact identifier
application number: M020
MINICELL UV SHIELD SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECELINA CO., LTD.48eff8fa-deec-a434-e063-6294a90aa8612026-01-21WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen Spf 30ZINC OXIDEDelta Ecommerce LLC47dbcf07-7e3a-e3de-e063-6294a90a2c212026-01-21WarningsExact identifier
application number: M020
sunscreenTITANIUM DIOXIDEGuangdong Zhoubang Biotechnology Co., Ltd48f13b1c-8104-881b-e063-6394a90a816d2026-01-21WarningsExact identifier
application number: M020
Sunscreen lip balmETHYLHEXYL SALICYLATEGuangdong Zhoubang Biotechnology Co., Ltd48f1ee5c-33d0-818c-e063-6294a90a1e592026-01-21WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen MotherCEILE SPF 30 PRIME PROTECT RADIATE MOTHERLE COSMETICS INC490db6ef-d7f2-446c-e063-6294a90af3032026-01-21WarningsExact identifier
application number: M020
DewyVita Zero Spot SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEBAREUNPLAN CO.,LTD.497c98c3-d809-52e0-e063-6294a90acca22026-01-21WarningsExact identifier
application number: M020
Mario Badescu The Moisture Magnet SPF 15OCTINOXATE, OXYBENZONE, AVOBENZONEBentley Laboratories LLC4c0b4733-96ea-4b1d-8a7b-13af66cc28d02026-01-21WarningsExact identifier
application number: M020
Sensitif Renewal Cream Daily Protection SPF 30 Broad Spectrum UVA UVB SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERV Skincare LLC86b46c9b-6573-439b-b38b-2d76d495df6d2026-01-20WarningsExact identifier
application number: M020
Perfectif Even Skin Tone Cream Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONERV Skincare LLC1b8cf189-0d06-4e86-bd7b-b77a638f16702026-01-20WarningsExact identifier
application number: M020
Bella s Friends SPF50 SunscreenZINC OXIDEPANERGYTEKUSAINC48ce4ef7-e24a-4894-e063-6294a90a49c82026-01-20WarningsExact identifier
application number: M020
Christian Dior Invisible UV Fluid with Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior93a27f09-14e2-47a0-ac5f-4d3425e31ec92026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade TenZINC OXIDEClean Beauty For All, Inc (dba Saie)d00b978d-1682-4cde-ae5f-189e677136c42026-01-20WarningsExact identifier
application number: M020
Saie Sunvisor Broad Spectrum SPF 35 Sheer MoisturizerZINC OXIDEClean Beauty For All, Incb6bfd636-2f46-3fca-e053-2a95a90a05a62026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer ShadeTwoZINC OXIDEClean Beauty For All, Inc (dba Saie)19230647-29a3-d209-e063-6394a90aae362026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Nine and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)8e2a2046-13e6-4a40-a0bc-65c979c59b932026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade EightZINC OXIDEClean Beauty For All, Inc (dba Saie)dbc4242a-3651-48be-bfc6-c595be5a2a152026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Three and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922f11d-10ce-82b4-e063-6394a90a66502026-01-20WarningsExact 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