FDA.reportPublic FDA data

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 216 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlgenistOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDESolazyme, Inc.4ece1847-1c94-4bf7-b936-109556a460a72025-04-22WarningsExact identifier
application number: M020
Sulwhasoo Perfecting Cushion NO.17N1 VanillaOCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATEAmorepacific Corporation3350f28e-22b4-904c-e063-6394a90a1c812025-04-21WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLCc914c4cd-99a2-4d9f-8f04-8af2ace3c3452025-04-18WarningsExact identifier
application number: M020
Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25ZINC OXIDECHARLIS LLC330f7470-0d53-7361-e063-6394a90a5d592025-04-18WarningsExact identifier
application number: M020
Chardonnay Lip OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc1318a429-d382-f5b8-e063-6394a90a3bd42025-04-18WarningsExact identifier
application number: M020
Shimmer OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc.131c63ba-57fc-9ce8-e063-6294a90acd922025-04-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC055431a6-e9e0-99b4-e063-6394a90acb112025-04-17WarningsExact identifier
application number: M020
SILKEN pore perfecting sunscreen broad spectrum SPF 35OCTISALATE, ZINC OXIDETATCHA INC.251566a1-0e21-4030-9d4e-52c4a8bd33302025-04-16WarningsExact identifier
application number: M020
Dermatone SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDermatone Labs LLC32e5bddf-a0b5-c511-e063-6294a90aaf662025-04-16WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF 30 Cool MintAVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%USRX3271ab14-3bf5-a24f-e063-6294a90a59bc2025-04-16WarningsExact identifier
application number: M020
goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECLIO COSMETICS Co., Ltd.77a0d190-f558-474b-89d2-c79b37c50c0d2025-04-16WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only - REFILLZINC OXIDESPF Ventures, LLC32ccb93a-50cf-f436-e063-6294a90a24922025-04-15WarningsExact identifier
application number: M020
DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEKOS America, Inc.2b41c17d-1394-0c2f-e063-6394a90a0c492025-04-15WarningsExact identifier
application number: M020
Urban Antioxidant Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMDr. Loretta, LLC930150a3-08bb-17fd-e053-2995a90a786b2025-04-15WarningsExact identifier
application number: M020
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
application number: M020
Dr.Ceuracle HYDRA BARRIER SUNSCREENZINC OXIDELeegeehaam Cosmetics22c05215-4983-b32e-e063-6394a90a9f672025-04-13WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3285e28d-5716-b576-e063-6294a90a89052025-04-11WarningsExact identifier
application number: M020
No7 Protect and Perfect Intense Advanced Fragrance Free Day Cream SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS32876315-f81f-fdd2-e063-6394a90ad5f72025-04-11WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3287ae2e-759e-31c5-e063-6394a90a892f2025-04-11WarningsExact 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