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 41 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Light Medium ZINC OXIDE ZO Skin Health, Inc. 4fabe9d0-27fe-230f-e063-6294a90a9ac0 2026-04-17 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Medium-Tan ZINC OXIDE ZO Skin Health, Inc. 4fac82b7-d685-2a0d-e063-6394a90aa795 2026-04-17 Warnings Exact identifier application number: M020 SALT WATER VANILLA SUNSCREEN BODY BROAD SPECTRUM SPF 50 SUNSCREEN Saltair Body LLC 4fae649d-f60e-0275-e063-6294a90a1ea5 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e64-2eab-1219-e063-6294a90a79a8 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cd8a3-3d62-83ac-e063-6394a90a4afa 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e2424f4-0011-42b0-e063-6394a90a780d 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHT YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316cfaea-b71f-2956-e063-6294a90a4f20 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316d1515-6092-a7d6-e063-6394a90ab8b2 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEP YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e246e70-6ec3-5711-e063-6394a90a3879 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 0e241343-db63-3f1c-e063-6394a90ab538 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316df5fe-0574-d59f-e063-6294a90af8b9 2026-04-17 Warnings Exact identifier application number: M020 YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOW YOUR NAME MINERAL SHEER TINT PML NYC, LLC 316c5d69-46f4-7677-e063-6294a90a610f 2026-04-17 Warnings Exact identifier application number: M020 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 PML NYC, LLC 316d905f-232c-d8a2-e063-6394a90adbc9 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 230 N PML NYC, LLC 316ea01b-4bff-55be-e063-6394a90add94 2026-04-17 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 410 N PML NYC, LLC 316e97bc-4b96-ba6e-e063-6294a90a7648 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c781d7-9d48-892f-e053-2a95a90aca86 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c757b4-6c92-18f0-e053-2a95a90a246d 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c76a82-dc87-35e7-e053-2995a90ae310 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7ac71-3f38-52b2-e053-2a95a90ab54e 2026-04-17 Warnings Exact identifier application number: M020 TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 BRIGHTENING SKIN TINT PML NYC, LLC f4c7b929-7492-f072-e053-2995a90a1ca3 2026-04-17 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 80949-002-07 80949000207 7 g in 1 TUBE (80949-002-07) 7 g 2020-01-05 No No Current