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 18 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 Minutes AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 511f6de9-264a-4cf2-97c3-aa8adbc52a87 2026-06-23 Warnings Exact identifier application number: M020 fmg Cashmere Lip Glaze Broad Spectrum SPF 30 Sunscreen ZINC OXIDE THE AVON COMPANY 54f1b153-c79b-bcf8-e063-6394a90ae426 2026-06-23 Warnings Exact identifier application number: M020 CVS 70 Daily Clear Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CVS PHARMACY 54f25934-b4c4-4fc8-e063-6294a90a543a 2026-06-23 Warnings Exact identifier application number: M020 Soleil Set sunscreen SPF 50 AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5% The Soleil Group cc4e4b99-5f42-4a93-a3a0-ea19f57d2783 2026-06-23 Warnings Exact identifier application number: M020 AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE THE AVON COMPANY 54f6d7c1-59d1-0b36-e063-6394a90a17a3 2026-06-23 Warnings Exact identifier application number: M020 RYDEEN UV CLEAR SUNSCREEN Guangzhou Oupeng Cosmetics Co., Ltd. 548000cd-1655-aeb3-e063-6294a90ad004 2026-06-22 Warnings Exact identifier application number: M020 Good Instincts Proper Sunscreen SPF 50 ZINC OXIDE, TITANIUM DIOXIDE Inhabit Brands, Inc 82d2af99-7c42-4ce5-94e0-b2ac60b8db1b 2026-06-22 Warnings Exact identifier application number: M020 Mama and Hapa s - Bulk Sunscreen Extra Sensitive ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 54e18569-2e51-366a-e063-6394a90af8ec 2026-06-22 Warnings Exact identifier application number: M020 ESPOIR BE VELVET COVER CUSHION HOMOSALATE, TITANIUM DIOXIDE ESPOIR Corporation 54ce2420-4ac0-eb51-e063-6294a90a2de9 2026-06-21 Warnings Exact identifier application number: M020 BABIES KIDSSUN PROTECTION MINERAL SUNSCREEN PANERGYTEK USA INC 3a554118-b71d-a844-e063-6294a90a699f 2026-06-20 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE COCO LOCO By the Beach Suncare LLC 549be1ca-df21-a643-e063-6394a90ac026 2026-06-19 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 FACE AND BODY DRY OIL COCO LOCO By the Beach Suncare LLC 549bad35-3005-875b-e063-6394a90ad31e 2026-06-19 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 FACE AND BODY DRY OIL MELON DAZE By the Beach Suncare LLC 549bbd19-8e22-e420-e063-6294a90a6a98 2026-06-19 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 FACE AND BODY DRY OIL CANDY CLOUDS By the Beach Suncare LLC 549bd1b1-a6e2-b35c-e063-6394a90a8d0e 2026-06-19 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 FACE AND BODY DRY OIL CITRUS CRUSH By the Beach Suncare LLC 549bd1b1-a6ee-b35c-e063-6394a90a8d0e 2026-06-19 Warnings Exact identifier application number: M020 FHF Elevated Shade 100% Mineral Sunscreen SUNSCREEN Summer Soles, LLC dba Farm House Freash Goods 5488fd8c-7ef2-22c2-e063-6394a90aff3c 2026-06-18 Warnings Exact identifier application number: M020 Stream2Sea Sport Lip Balm SPF 50 ZINC OXIDE Stream2Sea, LLC 5489fea5-bc0e-82cf-e063-6294a90aa097 2026-06-18 Warnings Exact identifier application number: M020 Creamy Beige Perfecting Makeup Broad Spectrum SPF 25 OCTINOXATE, TITANIUM DIOXIDE Merle Norman Cosmetics, Inc 548b7c90-ef97-38ab-e063-6394a90ac609 2026-06-18 Warnings Exact identifier application number: M020 UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENE CLINIQUE LABORATORIES LLC 4a6f9be3-2a56-8b41-e063-6294a90a30f8 2026-06-18 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 50 MINERAL SUNSCREEN ALAINA HEALTHCARE PRIVATE LIMITED 7e036f9f-b26d-4f11-911c-c1fa854edb0f 2026-06-17 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