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 36 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
White Mint SPF 15 Broad Spectrum Lip BalmWHITE MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc50ff8c38-94f1-f589-e063-6294a90a5ba82026-05-04WarningsExact identifier
application number: M020
Surface Sun SPF 50 MineralZINC OXIDESurface Products Corpcabaf7e1-b940-4d6e-b21b-d99c3a4047a72026-05-04WarningsExact identifier
application number: M020
SPF 50 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corp503d6b48-3516-4264-9fe8-71a9939669fe2026-05-04WarningsExact identifier
application number: M020
Surface SPF 50 3oz Tinted mineral sunscreen with Water ResistanceZINC OXIDESurface Products Corp02b770cf-7351-444b-b2c8-ad112e9bea3e2026-05-04WarningsExact identifier
application number: M020
SPF 30 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corpd13c9e6e-a5da-4691-8792-9d6025e166d72026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
application number: M020
OBGE PORE-ZERO Oil CONTROL SUN StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAdapt Inc.67209e46-1b7a-42df-b31f-fcb3cefbd7e12026-05-03WarningsExact identifier
application number: M020
EquateOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWALMART INC2617e5bc-27a2-f187-e063-6394a90a69802026-05-03WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Rice Tinted Mineral Sun CreamZINC OXIDETHANK YOU FARMER CO., LTD20a44597-3d44-f0ea-e063-6294a90a903d2026-05-03WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.4df3e90e-98a0-edbf-e063-6394a90ae3c92026-05-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENEGrace and Fire USA Inc.4df6d28b-64ce-59b3-e063-6394a90a63602026-05-01WarningsExact identifier
application number: M020
EXTREME PROTECT SPF 30OCTINOXATE, ZINC OXIDESCIENCE OF SKINCARE LLCecc4d304-e7e2-45b6-b9b2-2c64d36308602026-05-01WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
application number: M020
Sun Shield Mineral UV Barrier Protect Broad Spectrum SPF 40 SunscreenZINC OXIDEObagi Cosmeceuticals LLC54a3f855-48de-4ae0-b1f0-e957398530652026-05-01WarningsExact identifier
application number: M020
MEDICUBE PDRN HYDRATING UV SERUMHOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLEAPR US INC50a73981-985a-0a70-e063-6394a90a89cf2026-04-30WarningsExact identifier
application number: M020
Sky and Sol Body SunscreenNON- NANO ZINC OXIDEDelta Ecommerce LLC2ddaa628-0e81-c8a7-e063-6394a90a84f42026-04-30WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
application number: M020
Carmex 10 count variety pack Lip BalmOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.9c5168d5-31ed-4ce1-b16a-5f51f7e44ed22026-04-30WarningsExact 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