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 128 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032913b-4bc3-6920-e063-6294a90a6e2d2025-12-12WarningsExact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032f0b0-c083-d227-e063-6394a90a30682025-12-12WarningsExact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396d952b-22ff-567f-e063-6394a90a8c682025-12-12Exact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396dfc9c-b6c0-5892-e063-6394a90a110c2025-12-12Exact identifier
application number: M020
KawaKids KawaSun - Premium Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f41f64b-d707-08e2-e063-6294a90aa9242025-12-12WarningsExact identifier
application number: M020
KawaKids KawaSun - Premium On-The-Go Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f4341f7-b499-3b73-e063-6394a90a75b82025-12-12WarningsExact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f7f72-c426-e42f-e063-6294a90a4b3a2025-12-12Exact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f06f3-9deb-4c1a-e063-6394a90ad7662025-12-12Exact identifier
application number: M020
Daily Mineral ProtectionZINC OXIDECharisma Skin352d72f6-06b9-6fdc-e063-6294a90ab4482025-12-12Exact identifier
application number: M020
Daily Mineral ProtectionZINC OXIDECharisma Skin352dc69b-86d0-aa15-e063-6294a90a5e4c2025-12-12Exact identifier
application number: M020
Ultra Sheer SunscreenZINC OXIDESKINBAR MD LLC35810a90-e2ca-b80b-e063-6294a90a14f02025-12-12Exact identifier
application number: M020
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3531d609-a0d8-cb59-e063-6394a90a4bea2025-12-12Exact identifier
application number: M020
Non-Tinted Zinc Body And Face SPF40ZINC OXIDERSL89 LLC3532102c-8ded-1e78-e063-6294a90ae2242025-12-12Exact identifier
application number: M020
Non-Tinted Zinc Body And Face SPF40ZINC OXIDERSL89 LLC35330a82-dc6b-49af-e063-6394a90af9ea2025-12-12Exact identifier
application number: M020
Tinted Replenishing SPF40ZINC OXIDERSL89 LLC353257db-6c30-4a03-e063-6294a90ae45d2025-12-12Exact identifier
application number: M020
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3532a6a2-dbb5-8111-e063-6294a90aeaeb2025-12-12Exact identifier
application number: M020
Tinted Replenishing SPF40ZINC OXIDERSL89 LLC35334c75-b3fd-37fa-e063-6294a90ab3b02025-12-12Exact identifier
application number: M020
Age Defying SunscreenZINC OXIDEGINAMARIE Products35835565-f10b-e8e7-e063-6394a90ab2d32025-12-12Exact identifier
application number: M020
Tinted Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC35338026-525a-d8b3-e063-6394a90a98f52025-12-12Exact identifier
application number: M020
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3541971e-3664-a9f5-e063-6294a90ac2d22025-12-12Exact 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