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 137 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate SPF 50 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart Inc45b4d41b-c9ac-2c26-e063-6294a90a614f2025-12-11WarningsExact identifier
application number: M020
Mint ConditionZINC OXIDEMint Skin Incorporated353031d7-cc2d-426c-e063-6394a90a99ea2025-12-11Exact identifier
application number: M020
Body ProtectZINC OXIDENoble Center for Healthy Aging LLC387df843-b7d3-df2e-e063-6294a90a93f22025-12-11Exact identifier
application number: M020
Everyday Mineral Tinted SunscreenZINC OXIDEAtlanta Acne Specialists, LLC351e6ca8-c6cb-dd99-e063-6294a90af0cf2025-12-11Exact identifier
application number: M020
Mint ConditionZINC OXIDEMint Skin Incorporated3530efd2-b122-9aba-e063-6394a90a89532025-12-11Exact identifier
application number: M020
The Tinted Mineral SunscreenZINC OXIDEThe Hue Solution L.L.C.37f30a04-8ffa-09de-e063-6294a90aba052025-12-11Exact identifier
application number: M020
Abib Airy clear sunscreen gel Smoothing tubeHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEFourcompany Co., Ltd.33d1a5da-68c3-b16e-e063-6294a90a70062025-12-10WarningsExact identifier
application number: M020
Non Tinted Mineral Moisturizing SunscreenZINC OXIDEABOUT FACE AESTHETICS, INC.3647a985-5365-a9e0-e063-6294a90ac0a42025-12-10Exact identifier
application number: M020
ProtectME Tinted Mineral SPF 40 20%ZINC OXIDEPUREFECTION LA, INC.33dd1afa-25a8-891f-e063-6294a90a8c8a2025-12-10Exact identifier
application number: M020
ProtectME Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEPUREFECTION LA, INC.33dccd5d-8db1-f699-e063-6394a90a59a22025-12-10Exact identifier
application number: M020
Protect ME Non Tinted Mineral SPF 40ZINC OXIDEPUREFECTION LA, INC.34a2d716-b853-752e-e063-6394a90a52e22025-12-10Exact identifier
application number: M020
Tinted Mineral Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEABOUT FACE AESTHETICS, INC.364728b4-e0ff-8466-e063-6394a90a00892025-12-10Exact identifier
application number: M020
tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d42661-e511-1dfc-e063-6294a90a9ed72025-12-10Exact identifier
application number: M020
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d3ef95-621c-f193-e063-6294a90ac3ee2025-12-10Exact identifier
application number: M020
face Plus body sunscreen tintedZINC OXIDESkin & Bare It LLC35d45df5-e9bf-1a08-e063-6294a90ae04f2025-12-10Exact identifier
application number: M020
face Plus body sunscreen non-tintedZINC OXIDESkin & Bare It LLC361ef750-0f0e-bd01-e063-6294a90a00202025-12-10Exact identifier
application number: M020
bare skin smooth mineral tintZINC OXIDESkin & Bare It LLC361f2933-73d5-a9d7-e063-6394a90abb3c2025-12-10Exact identifier
application number: M020
Smoothing Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION32721b87-aef1-d759-e063-6394a90a40d32025-12-10Exact identifier
application number: M020
Non-Tinted Mineral StickTITANIUM DIOXIDE, ZINC OXIDEShelley Bennett Skincare326e9a14-5fb6-6a6e-e063-6294a90adece2025-12-10Exact identifier
application number: M020
3-in-1 Daily Vanishing Tinted Sunscreen CreamZINC OXIDEShelley Bennett Skincare325dae60-01cc-a120-e063-6294a90a2ef22025-12-10Exact 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