Advanced Formula Lip Balm SPF 25

Product NDC
80949-001
11-digit product format
809490001
Labeler code
80949
Product ID
80949-001_4d248a7a-9ddb-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 productproduct80949-001UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage80949-00180949-001-07UExcluded 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
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
74d7bc30-db15-4cfc-8918-40897d54da70Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80949-001-07Advanced Formula Lip Balm SPF 257 g in 1 TUBECREAM73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80949-001ADVANCED FORMULA LIP BALM SPF 25 (AVOBENZONE, OCTINOXATE) CREAM [ANTHONY SKIN LLC]2Current NDC, 1 package rows20250116_74d7bc30-db15-4cfc-8918-40897d54da70.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 246 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Badger SPF 30 Daily SunscreenZINC OXIDEW.S. Badger Company, Inc.11e65bae-2361-5440-e063-6294a90a075e2024-12-31WarningsExact identifier
application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATEREVLONd09ab4ca-6d5c-47bd-e053-2a95a90a409d2024-12-31WarningsExact identifier
application number: M020
Almay Healthy Biome Makeup FairHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a947e1d-286f-a939-e063-6394a90a07192024-12-31WarningsExact identifier
application number: M020
Almay Healthy Biome Makeup TanHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a94a668-24cb-e0f2-e063-6294a90a79d32024-12-31WarningsExact identifier
application number: M020
Almay Healthy Biome Makeup MediumHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a94c0a2-8a47-39b9-e063-6394a90acf8c2024-12-31WarningsExact identifier
application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20TITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a962944-9155-9b70-e063-6294a90ac5352024-12-31WarningsExact identifier
application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 MediumTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a96811c-3ea6-15bc-e063-6394a90ac3bd2024-12-31WarningsExact identifier
application number: M020
Revlon Colorstay Liquid Makeup for Normal to Dry SkinZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp414538d6-9108-54bf-e054-00144ff8d46c2024-12-31WarningsExact identifier
application number: M020
Revlon Colorstay Preo and Protect PrimerTITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE PRIMERRevlon Consumer Products Corp8eebf23e-7fce-dfc0-e053-2995a90ae3222024-12-31WarningsExact identifier
application number: M020
Revlon Kiss Balm SPF 20AVOBENZONE, BENZOPHENONE-3, OCTINOXATERevlon Consumer Products Corp410d1cb2-6c90-1ca3-e054-00144ff8d46c2024-12-31WarningsExact identifier
application number: M020
Revlon PhotoReady BB Cream Skin PerfectorOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp410ca372-4698-029d-e054-00144ff8d46c2024-12-31WarningsExact identifier
application number: M020
Revlon Colorstay Liquid Makeup for Oily to Combination SkinZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp410d1cb2-6c92-1ca3-e054-00144ff8d46c2024-12-31WarningsExact identifier
application number: M020
REVLON PHOTOREADY INSTA-FIX MAKEUPTITANIUM DIOXIDE, ZINC OXIDERevlon Consumer Products Corp442f2a06-47c0-2522-e054-00144ff88e882024-12-31WarningsExact identifier
application number: M020
Revlon Youth FXZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp442dec1e-032c-28de-e054-00144ff8d46c2024-12-31WarningsExact identifier
application number: M020
Almay Smart Shade Skintone Matching Makeup MediumTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a971e38-af63-e069-e063-6294a90a8f772024-12-31WarningsExact identifier
application number: M020
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corpd9209277-469d-48f4-bf64-f39a70c195962024-12-31WarningsExact identifier
application number: M020
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc097fc15e-ea17-47b2-9581-19c5e11592f62024-12-30WarningsExact identifier
application number: M020
HERBAL UV DEFENSE SPF40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENECOSMAX USA, CORPORATION2a76fd94-2f1f-e6d8-e063-6294a90a287c2024-12-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80949-001-07809490001077 g in 1 TUBE (80949-001-07) 7 g2020-01-05NoNoCurrent