Home NDC 80949-002-07 Advanced Formula Lip Balm SPF 25
Product NDC 80949-002
Requested package NDC 80949-002-07
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 · 1 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 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 179 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Buff ZINC OXIDE Cosmetic Enterprises Ltd 265bc5e0-0a2a-842e-e063-6394a90aae0a 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Mocha ZINC OXIDE Cosmetic Enterprises Ltd 2748b6bc-e80b-ce66-e063-6394a90a400a 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Bronze ZINC OXIDE Cosmetic Enterprises Ltd 265bf123-c4c3-8414-e063-6394a90a4730 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Ivory ZINC OXIDE Cosmetic Enterprises Ltd 2748c351-0a7d-6913-e063-6394a90a6ef2 2025-10-13 Warnings Exact identifier application number: M020 Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Nude ZINC OXIDE Cosmetic Enterprises Ltd 265bd73f-2509-90c6-e063-6294a90a2e19 2025-10-13 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC dad4b244-2d34-40cb-88dc-991358df83b0 2025-10-10 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Kids Sunscreen SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC eafc00ce-12e7-921f-e053-2995a90a241a 2025-10-10 Warnings Exact identifier application number: M020 Meijer SPF 50 Sunscreen Mango AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 40d0294b-e937-336d-e063-6294a90a5c3c 2025-10-10 Warnings Exact identifier application number: M020 Vertra S Dorian Kona Gold Signature Face Stick SPF 38 TITANIUM DIOXIDE Eai-jr 286, Inc b6c316c3-661b-6428-e053-2a95a90a1a6b 2025-10-10 Warnings Exact identifier application number: M020 Meijer SPF 50 Sunscreen Coconut AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Meijer 40d15366-85b8-f5e8-e063-6294a90a5fd8 2025-10-10 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4369f2f-fdc3-e48e-e053-2995a90a07f7 2025-10-10 Warnings Exact identifier application number: M020 Sun Bum Face 50 Premium Sunscreen SPF 50 AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE Wasatch Product Development, LLC f4ac746a-a50a-8041-e053-2a95a90a8ea6 2025-10-10 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 ZINC OXIDE Wasatch Product Development, LLC. e895d942-e50e-1ad6-e053-2995a90a0e02 2025-10-10 Warnings Exact identifier application number: M020 Illuminating SPF 50 plus drops Broad Spectrum Sunscreen ZINC OXIDE Cosmetic Enterprise Ltd 13f40485-b98e-e804-e063-6394a90af2af 2025-10-10 Warnings Exact identifier application number: M020 Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Cosmetic Enterprises LTD a84d246b-1153-85ff-e053-2995a90a270a 2025-10-10 Warnings Exact identifier application number: M020 MediChoice Moisturizing Lip Balm SPF15 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE O&M HALYARD, INC. 00327815-28f0-4198-bca7-c8ae768ff416 2025-10-09 Warnings Exact identifier application number: M020 Daybird 4-in-1 Skin Tint Serum ZINC OXIDE Resette, Inc. 19c1a934-b0f5-1068-e063-6294a90a3b1f 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 604) ZINC OXIDE B.A.I. Biosciences INC. f4ebbc1d-d521-1a47-e053-2a95a90a6f84 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 774) ZINC OXIDE B.A.I. Biosciences INC. f4ebd850-11a8-0d43-e053-2a95a90a2d34 2025-10-09 Warnings Exact identifier application number: M020 pavise Lip Defense tinted hydrating oil (hue 616) ZINC OXIDE B.A.I. Biosciences INC. f4eb6b20-7c26-2942-e053-2a95a90abd31 2025-10-09 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