FDA.reportPublic FDA data

Advanced Formula Lip Balm SPF 25

Product NDC
80949-002
11-digit product format
809490002
Labeler code
80949
Product ID
80949-002_4d248a7a-9dcc-8e9f-e063-6294a90aa703
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate
Dosage form
CREAM
Route
TOPICAL
Labeler
Anthony Skin LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-05
Substance
AVOBENZONE; OCTINOXATE
Active strength
3; 7.5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct80949-002UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage80949-00280949-002-07UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Advanced Formula Lip Balm SPF 25
Brand name suffix
Blood Orange
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
OCTINOXATE7.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
74853b40-a773-4488-98a9-c8029ad21134Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80949-002-07Advanced Formula Lip Balm SPF 25Blood Orange7 g in 1 TUBECREAM73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80949-002ADVANCED FORMULA LIP BALM SPF 25 BLOOD ORANGE (AVOBENZONE, OCTINOXATE) CREAM [ANTHONY SKIN LLC]2Current NDC, 1 package rows20250116_74853b40-a773-4488-98a9-c8029ad21134.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 59 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab66c16-5f4c-6987-e063-6294a90add862026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
Seonglow Daily Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeonGlow Inc.01f3479f-3a0d-420b-bbf8-62a0a225bc9b2026-02-26WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab5d5ca-26bf-1c5f-e063-6394a90a00ca2026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
SPF50 Moisturizer with Aloe, Green Tea and Shea ButterZINC OXIDEAudrey Morris Cosmetics International, LLC92960e14-9845-49aa-b3ce-c8023aa109b62026-02-26WarningsExact identifier
application number: M020
Naturalessa SPF50 MoisturizerZINC OXIDEAudrey Morris Cosmetics International, LLC816ddfa1-cb55-4591-a90b-71631cb176262026-02-26WarningsExact identifier
application number: M020
UV DEFENSE FACE MINERAL SPF 50ZINC OXIDEBETTER INVENTION LTD4b9a9efe-9aba-0ed0-e063-6394a90a2c6b2026-02-26WarningsExact identifier
application number: M020
MISTINE UV DEFENSE FACE SUNSCREEN SPF50AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9043-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9041-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
Rationale The Discovery Travel KitZINC OXIDERATIONALE GROUP PTY LTD0c919aea-4bd4-427e-97e7-9c153b42f4912026-02-25WarningsExact identifier
application number: M020
Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50ZINC OXIDEWindmill Health Products, LLCebfb149c-0371-4492-b03a-5fdcb78217532026-02-25WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE Protective DayAVOBENZONE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporationdea8e4c1-6a9c-44c6-abc8-6cdd50f35f492026-02-25WarningsExact identifier
application number: M020
Aura DefenseZINC OXIDEGrace and Glow MD LLC4ba75eff-74ef-278b-e063-6394a90a8ef02026-02-25WarningsExact identifier
application number: M020
AM Shield plusZINC OXIDEGrace and Glow MD LLC4ba7c282-c68e-8719-e063-6394a90a38142026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4babe2ab-c5da-9a83-e063-6294a90aee4c2026-02-25WarningsExact identifier
application number: M020
Daily Facial Moisturizer SPF 25SUNSCREENPerson and Covey6b9258e4-c7c6-765e-e053-2991aa0a9f4e2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac1c33-36fe-8d29-e063-6394a90a32a52026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac5550-c45f-a738-e063-6394a90ae5c82026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baca374-7aaa-8d1d-e063-6394a90a5a552026-02-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80949-002-07809490002077 g in 1 TUBE (80949-002-07) 7 g2020-01-05NoNoCurrent