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 167 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Well People Bio Tint SPF 30 Sunscreen 12wZINC OXIDEe.l.f. Cosmetics, Incc8a99278-21e0-c517-e053-2a95a90ade372025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 1CZINC OXIDEe.l.f. Cosmetics, Incc8a82c8b-e308-15e9-e053-2995a90afa2a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 14wZINC OXIDEe.l.f. Cosmetics, Incc8aa4629-1573-48a7-e053-2995a90aa86c2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 2wZINC OXIDEe.l.f. Cosmetics, Inc.c8a82f54-839d-1de0-e053-2a95a90a2a972025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 4WZINC OXIDEe.l.f. Cosmetics, Incc8a83921-3181-396e-e053-2a95a90a02ee2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 3NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce3e-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 5NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce42-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 6wZINC OXIDEe.l.f. Cosmetics, Incc8a8ef6f-4426-a981-e053-2a95a90a94512025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen PEACHZINC OXIDEe.l.f. Cosmetics, Incc8aa931b-a3b4-6804-e053-2995a90a3eab2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 7NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce45-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 8NZINC OXIDEe.l.f. Cosmetics, Incc8aa662c-0f06-712b-e053-2995a90aae0b2025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen AFTERGLOWZINC OXIDEe.l.f. Cosmetics, Incc8aa9325-4fad-ddf9-e053-2a95a90a66392025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 9wZINC OXIDEe.l.f. Cosmetics, Incc8a92c58-d981-0948-e053-2a95a90a16f82025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen WINEZINC OXIDEe.l.f. Cosmetics, Incc8aa873e-8271-8cf0-e053-2995a90a3cec2025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen NATURALZINC OXIDEe.l.f. Cosmetics, Incc8aa7ae9-7d03-db7d-e053-2995a90ae72b2025-11-07WarningsExact identifier
application number: M020
Neutrogena Clear Face Serum Fragrance Free SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeb705402-f8cb-5079-e053-2a95a90a405c2025-11-06WarningsExact identifier
application number: M020
Neutrogena Cool Dry Sport Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC5c1a0437-c269-4cd3-b91a-e2de799b853e2025-11-06WarningsExact identifier
application number: M020
Neutrogena Clear Face Breakout Free oil Free Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC10ca67ca-c372-44a9-8933-84cce9fb99342025-11-06WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0464448b-342b-4e54-a20e-6ec6bd6228892025-11-06WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC7f60d6bd-1735-4390-bc8a-e3876ab7ad502025-11-06WarningsExact 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