Home NDC 10596-806 Hello Sunday The One For Your Lips Clear Lip Balm SPF 50
Product NDC 10596-806
11-digit product format 105960806
Labeler code 10596
Product ID 10596-806_43d0f364-238d-9fae-e063-6394a90a4777
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form STICK
Route TOPICAL
Labeler Kao USA Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-01
Substance OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength 50; 30; 90; 73 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10596-806-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10596-806-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10596-806-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10596-806-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10596-806-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10596-806-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10596-806-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10596-806-01 U Excluded because listing certification expired 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 Hello Sunday The One For Your Lips Clear Lip Balm SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 50 mg/mL AVOBENZONE 30 mg/mL OCTOCRYLENE 90 mg/mL HOMOSALATE 73 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10596-806-01 Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 15 mL in 1 TUBE STICK 15 2 10596-806-01 Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 1 in 1 CARTON STICK 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10596-806 HELLO SUNDAY THE ONE FOR YOUR LIPS CLEAR LIP BALM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [KAO USA INC.] 1 Current NDC, 2 package rows 20240201_0c92dfc3-782d-e11f-e063-6394a90a2f8a.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 141 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Physical Block Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tucson Acne Clinic 30dc6e23-ecca-ed0b-e063-6294a90a7951 2025-12-09 Warnings Exact identifier application number: M020 Tinted Physical Block Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tucson Acne Clinic 30ddc3d7-76df-3344-e063-6294a90a65ae 2025-12-09 Warnings Exact identifier application number: M020 Tinted Physical Block Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tucson Acne Clinic 30ddf80c-8496-0f47-e063-6394a90afc18 2025-12-09 Warnings Exact identifier application number: M020 Lightly Tinted Mineral Block Sunscreen ZINC OXIDE Tucson Acne Clinic 30dfa973-3217-1e18-e063-6294a90a8d41 2025-12-09 Warnings Exact identifier application number: M020 Lightly Tinted Mineral Block Sunscreen ZINC OXIDE Tucson Acne Clinic 30df0039-4dc1-7355-e063-6394a90ae800 2025-12-09 Warnings Exact identifier application number: M020 Advanced Lip Guard TITANIUM DIOXIDE, ZINC OXIDE ADVANCED DERMATOLOGY 32e66ff3-ae1a-4a2a-e063-6294a90a7963 2025-12-09 Exact identifier application number: M020 Skin Tone Defender 20% Zinc Oxide ZINC OXIDE Cali Skin Care LLC 308c711d-4c3e-1208-e063-6394a90a9cc2 2025-12-09 Warnings Exact identifier application number: M020 Advanced Light Perfecting Sunscreen ZINC OXIDE ADVANCED DERMATOLOGY 32d781ca-7993-9875-e063-6294a90a5c26 2025-12-09 Exact identifier application number: M020 Advanced Light Perfecting Sunscreen ZINC OXIDE Advanced Dermatology 32e6c080-6ce3-8d99-e063-6294a90ac1bc 2025-12-09 Exact identifier application number: M020 StriVectin multi-action Super-C SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE StriVectin Operating Company, Inc. b299df12-fbdd-437b-9bfa-4846e361725a 2025-12-09 Warnings Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L.S. MOORE LLC 37f1e019-32c4-b733-e063-6394a90aca28 2025-12-09 Exact identifier application number: M020 RADIANCE ZINC OXIDE L.S. MOORE LLC 37f254cb-9de5-8f67-e063-6294a90a4e28 2025-12-09 Exact identifier application number: M020 StriVectin Advanced Retinol Daily Repair Moisturizer SPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE StriVectin Operating Company, Inc. cfbdbba8-a739-fd32-e053-2a95a90a6f31 2025-12-09 Warnings Exact identifier application number: M020 Hint of Tint ZINC OXIDE L.S. MOORE LLC 37f20c14-070e-4f86-e063-6294a90ad4c2 2025-12-09 Exact identifier application number: M020 Hint of Tint ZINC OXIDE L.S. MOORE LLC 37f330a0-790a-1656-e063-6294a90a691c 2025-12-09 Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L.S. MOORE LLC 37f2e363-e85f-f601-e063-6294a90ab120 2025-12-09 Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L MOORE AESTHETICS 37f1ac8c-3bfb-10da-e063-6294a90a8ca8 2025-12-09 Exact identifier application number: M020 RoC Multi Correxion Revive and Glow Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RoC Skincare 40d4cfeb-fb00-801e-e063-6394a90ada6b 2025-12-09 Warnings Exact identifier application number: M020 RADIANCE ZINC OXIDE L.S. MOORE LLC 37f2b104-0213-c88c-e063-6294a90a4247 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Moisturizing Lightly Tinted ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 3350c673-2afd-a00a-e063-6294a90aa196 2025-12-09 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 10596-806-01 10596080601 1 TUBE in 1 CARTON (10596-806-01) / 15 mL in 1 TUBE 1 tube 2024-02-01 No No Current