Home NDC 80949-001 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 80949-001 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 80949-001 80949-001-07 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…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 Ingredient Strength AVOBENZONE 3 g/100g OCTINOXATE 7.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4Y5P7MUD51 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80949-001-07 Advanced Formula Lip Balm SPF 25 7 g in 1 TUBE CREAM 7 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80949-001 ADVANCED FORMULA LIP BALM SPF 25 (AVOBENZONE, OCTINOXATE) CREAM [ANTHONY SKIN LLC] 2 Current NDC, 1 package rows 20250116_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 206 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Introstem Vitiscell Facial Shield OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 65c28ed6-649d-41d9-b214-aab6ccb02dd5 2025-07-01 Warnings Exact identifier application number: M020 Bath and Body Works SPF Tahiti Isle AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 38d049b4-557f-724a-e063-6394a90a19b3 2025-06-30 Warnings Exact identifier application number: M020 Bath and Body Works SPF Tahiti Isle AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 2f74965f-3c84-0590-e063-6294a90af267 2025-06-30 Warnings Exact identifier application number: M020 Bath and Body Works SPF Tahiti Isle AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 38d0d165-e981-284a-e063-6294a90acace 2025-06-30 Warnings Exact identifier application number: M020 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKIN AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc a3dc6195-3011-4e7f-b1b0-0c815b11ba8d 2025-06-30 Warnings Exact identifier application number: M020 Youth to the People Youthscreen Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE AND OCTISALATE LOreal USA Products Inc 5712df74-5201-474b-bbfd-703f3117bd9c 2025-06-30 Warnings Exact identifier application number: M020 BINDA Vitamin C and hyaluronic acid Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38bff6d0-5690-3ee5-e063-6294a90a9faa 2025-06-29 Warnings Exact identifier application number: M020 Vertra S Dorian Kona Gold Signature Face Stick SPF 38 TITANIUM DIOXIDE Toshiki Pigment Co., ltd. b7162a2f-07f1-6188-e053-2995a90a8a9c 2025-06-27 Warnings Exact identifier application number: M020 Orchidee Double Defense Skin Shield OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 74b3c33f-5db5-460d-97be-fa495b625249 2025-06-27 Warnings Exact identifier application number: M020 GHOSTED ZINC OXIDE Spooge a5b611c3-d4d3-461e-84d8-d04a29c74902 2025-06-26 Warnings Exact identifier application number: M020 Dew Me ZINC OXIDE Spooge 0c4b429b-7dd5-4929-95af-d02b6770f121 2025-06-26 Warnings Exact identifier application number: M020 Zinc FIVE-0 baby and kids mineral sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38744f77-4845-eac4-e063-6294a90af648 2025-06-26 Warnings Exact identifier application number: M020 NYU Langone Health Lip Balm ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 38745b55-8da5-4627-e063-6394a90a24ca 2025-06-26 Warnings Exact identifier application number: M020 Active Skin Repair hydrating daily sunscreen ZINC OXIDE Innovacyn, Inc. 1eacdde1-f990-4962-92f1-3f41a8a3b193 2025-06-26 Warnings Exact identifier application number: M020 Cheeky ZINC OXIDE Spooge d377379a-a1be-4acf-9df5-2ff73fb5c83d 2025-06-26 Warnings Exact identifier application number: M020 TheOG ZINC OXIDE Spooge a2f781a8-eba8-48f5-8680-9235aae8a4ff 2025-06-26 Warnings Exact identifier application number: M020 Reef safe - Vitamin C sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f0763-74e9-3a71-e063-6394a90a46fb 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - acne-prone sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f079c-5730-5111-e063-6394a90af2d8 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Zinc Face sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f0f79-016f-71a7-e063-6394a90a9286 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Baby zinc sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f320c-9144-78b8-e063-6394a90a2e9d 2025-06-25 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80949-001-07 80949000107 7 g in 1 TUBE (80949-001-07) 7 g 2020-01-05 No No Current