FDA.reportPublic FDA data

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 79 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior58efeaaf-d3c6-44e9-b60f-8f22f5bb1d332026-01-16WarningsExact identifier
application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6b4a90b-5905-4f62-9e35-f2b1dda8dddd2026-01-16WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Watermelon SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC42c8fd50-73c6-480b-9d7e-31157e5869292026-01-16WarningsExact identifier
application number: M020
HYDRA VIZOR HUEZ TINTED MOISTURIZER BROAD SPECTRUM SPF 30ZINC OXIDEKENDO HOLDINGS INC.18fb7472-746f-339a-e063-6294a90a267d2026-01-16WarningsExact identifier
application number: M020
THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50ZINC OXIDENoble Panacea Labs, Inc.aed57f81-4b7d-42dc-993e-6bb10f93b02a2026-01-16WarningsExact identifier
application number: M020
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd0d9f132c-7630-4261-a0f8-fc7a4377731f2026-01-16WarningsExact identifier
application number: M020
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdf292da7d-ffd2-41c3-9a64-619aab19ff182026-01-15WarningsExact identifier
application number: M020
Multivit Sun ProtectorTITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltdabdb560d-29be-41dc-ad23-54ea571acb142026-01-15WarningsExact identifier
application number: M020
BeautyBarrierZINC OXIDENAKED SUNDAYS PTY LTD45740afa-230d-4dd5-e063-6394a90a102f2026-01-15WarningsExact identifier
application number: M020
Glow This WayOCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATEKoco Life LLC4619cf96-987a-3e88-e063-6294a90afbe92026-01-15WarningsExact identifier
application number: M020
Reef safe lip balm 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.486930f2-026b-14b4-e063-6394a90aa0312026-01-15WarningsExact identifier
application number: M020
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENECLINIQUE LABORATORIES LLC316bf6f8-7d30-2560-e063-6294a90afb8a2026-01-15WarningsExact identifier
application number: M020
Wellcare Sunstick Lip BalmAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATEBAMKO, LLCef977575-7ef0-fc09-e053-2a95a90a89932026-01-15WarningsExact identifier
application number: M020
Bali Body Sheer Glow Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd4872793c-a7c0-1b65-e063-6394a90a8b3a2026-01-15WarningsExact identifier
application number: M020
Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 SunscreenZINC OXIDEVolition Beauty2631de4b-66e3-0547-e063-6394a90a822c2026-01-15WarningsExact identifier
application number: M020
AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30ZINC OXIDESKINN COSMETICS, LLC350ed168-ab3b-f314-e063-6394a90a8bbf2026-01-15WarningsExact identifier
application number: M020
StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEStriVectin Operating Company, Inc.4873a262-a19b-555e-e063-6394a90a182a2026-01-15WarningsExact identifier
application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLCe843bb6b-257f-4425-95bc-41774e032a092026-01-15WarningsExact identifier
application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENThe Center Brands, LLC1e18f1dd-a4e4-455a-9699-5634b95596782026-01-15WarningsExact identifier
application number: M020
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company485c345f-0928-fa1a-e063-6294a90aa8562026-01-14WarningsExact 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