Home NDC 80949-002 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 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 80949-002 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 80949-002 80949-002-07 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
Brand name suffix Blood Orange
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 80949-002-07 Advanced Formula Lip Balm SPF 25Blood Orange 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 80949-002 ADVANCED FORMULA LIP BALM SPF 25 BLOOD ORANGE (AVOBENZONE, OCTINOXATE) CREAM [ANTHONY SKIN LLC] 2 Current NDC, 1 package rows 20250116_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 342 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium Shade SPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADE Autumn Harp fd6807e1-c8c0-b361-e053-6294a90aea0c 2023-06-05 Warnings Exact identifier application number: M020 Thinksport Clear Zinc SPF 50 ZINC OXIDE thinkOperations,LLC b5ce523f-eee8-f1a8-da19-b3dc14f8a58e 2023-05-31 Warnings Exact identifier application number: M020 Thinksport Mineral SPF 50 ZINC OXIDE AND TITANIUM DIOXIDE thinkOperations,LLC 77b63c0b-353b-4f5f-95c7-6f7eeab81471 2023-05-30 Warnings Exact identifier application number: M020 Think Kids Mineral SPF 50 ZINC OXIDE AND TITANIUM DIOXIDE thinkOperations,LLC 25c59820-a08d-4abe-87ae-a787ac8b2ac2 2023-05-30 Warnings Exact identifier application number: M020 Topix Mineral Mattifying Tinted Sunscreeninted SPF 50 ZINC OXIDE Topiderm, Inc. 46c6f20f-4bb6-47c6-9eac-17ca97bb14a7 2023-03-20 Warnings Exact identifier application number: M020 Replenix Sunscreen SPF 50 ZINC OXIDE Topiderm, Inc. 9223ffa8-7af3-4407-9170-482afec536d8 2023-02-24 Warnings Exact identifier application number: M020 Bath and Body Works SPF20 Coconut Lip Balm SPF20 LIP BALM Autumn Harp f5744a48-2b39-4949-e053-2a95a90ab15d 2023-02-24 Warnings Exact identifier application number: M020 Replenix Tinted Sunscreen SPF 50 ZINC OXIDE AND OCTINOXATE Topiderm, Inc. 1fda4a54-e323-4f3c-b659-bded4b1b3dd0 2023-02-22 Warnings Exact identifier application number: M020 Topix Mineral Mattifying Tinted Sunscreen SPF 50 ZINC OXIDE Topiderm, Inc. ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e91 2023-02-22 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 3a637542-0f79-47ae-815d-84d0036c737a 2023-02-13 Warnings Exact identifier application number: M020 Essential Moisturizing Sunscreen ZINC OXIDE, OCTINOXATE Topiderm, Inc. 450d916e-4c77-489e-86b1-78b686355476 2023-02-09 Warnings Exact identifier application number: M020 Mineral Repair SPF 45 ZINC OXIDE Topiderm, Inc. 84580f10-3119-4253-87a6-53d24a1f2227 2023-02-07 Warnings Exact identifier application number: M020 Think Aloe and Tea Leaves Zinc oxide ZINC OXIDE thinkOperations,LLC 9965ccd1-821d-4d9d-8a56-e87440b809ee 2023-02-02 Warnings Exact identifier application number: M020 Replenix Lip Therapy homosalate HOMOSALATE Topiderm, Inc. b60dc004-d713-47bc-a6e9-ea4783aa7019 2023-02-02 Warnings Exact identifier application number: M020 Josie Maran Argan Daily Moisturizer SPF47 ZINC OXIDE, TITANIUM DIOXIDE Autumn Harp, Inc. 027821e6-db7d-4c03-956a-00313488ebc7 2023-01-14 Boxed warning, Warnings Exact identifier application number: M020 Tinted Lip Balm SPF30 Wild Peony SPF30 LIP BALM Autumn Harp d0604720-623a-e8a9-e053-2995a90ab0e6 2023-01-10 Warnings Exact identifier application number: M020 Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a39d91c-2dcf-71d6-e063-6394a90a5474 2022-02-10 Warnings Exact identifier application number: M020 Basin Mexican Vanilla SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a3a63d3-c7e0-bf03-e063-6394a90a1662 2022-02-10 Warnings Exact identifier application number: M020 Basin Norwegian Berry SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3a3c0aa0-7501-7ef0-e063-6294a90a9f94 2022-02-10 Warnings Exact identifier application number: M020 Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35 OCTINOXATE AND OXYBENZONE Groupe Marcelle Inc. c24ac3ad-b2e2-4381-bd80-a499da0e0670 2021-12-14 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 80949-002-07 80949000207 7 g in 1 TUBE (80949-002-07) 7 g 2020-01-05 No No Current