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 143 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316b46ac-6dde-72d1-e063-6294a90a03da 2025-12-09 Exact identifier application number: M020 Replenish ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316c43fb-0c15-87d4-e063-6294a90a0a63 2025-12-09 Exact identifier application number: M020 BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories ece7565b-f3e5-3386-e053-2a95a90a5802 2025-12-09 Warnings Exact identifier application number: M020 Hydraboost Lip Treatment AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Bluemercury 2cf30083-8723-23f6-e063-6394a90a55de 2025-12-09 Warnings Exact identifier application number: M020 Florida Babe Sport Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31e4756d-8604-6e75-e063-6294a90aebe1 2025-12-09 Exact identifier application number: M020 Florida Babe Sport Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31e4d9ae-f532-f9f5-e063-6294a90a8d39 2025-12-09 Exact identifier application number: M020 Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Arbonne International, LLC 91bcd120-28e5-4f44-9522-550c1dbcd82c 2025-12-09 Warnings Exact identifier application number: M020 Florida Babe Active Tinted 20percent Zinc Oxide Mineral Sunscreen ZINC OXIDE Tichy Anesthesia PA 31e509f2-dcb6-5ae0-e063-6394a90a70c1 2025-12-09 Exact identifier application number: M020 Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral Sunscreen ZINC OXIDE Tichy Anesthesia PA 31e57817-b8c4-8178-e063-6294a90a0149 2025-12-09 Exact identifier application number: M020 Florida Babe Everyday Tinted Replenishing Daily Protection ZINC OXIDE Tichy Anesthesia PA 3231f1fe-51b3-b2e7-e063-6394a90a2758 2025-12-09 Exact identifier application number: M020 Florida Babe Everyday Tinted Replenishing Daily Protection ZINC OXIDE Tichy Anesthesia PA 31e63876-3e39-adc6-e063-6394a90ab146 2025-12-09 Exact identifier application number: M020 Florida Babe SPORT Mineral Sunscreen Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31f5bbe4-5f6e-3bef-e063-6294a90a2646 2025-12-09 Exact identifier application number: M020 Florida Babe SPORT Mineral Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31f54a79-70b7-def5-e063-6294a90a709b 2025-12-09 Exact identifier application number: M020 Florida Babe Sport Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 3231b71c-4d27-e5e2-e063-6294a90a031b 2025-12-09 Exact identifier application number: M020 Arbonne Soft Focus Veil Broad Spectrum SPF 30 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Arbonne International, LLC 3c9b605b-5a16-4f89-a956-8c4c62de72d3 2025-12-09 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE AESTHETICS ACADEMY, LLC 364b9560-f7a1-ed8f-e063-6294a90a2c41 2025-12-09 Exact identifier application number: M020 Sunshield Moisturizing Sunscreen and Antioxidant ZINC OXIDE Oculofacial Surgery andCosmetic Laser Institute, LLC. 32c247fc-d4da-e03d-e063-6394a90a72b0 2025-12-09 Exact identifier application number: M020 SCALP SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE FOLICULE LLC 387b10e1-5443-7b7a-e063-6394a90a2c7a 2025-12-09 Exact identifier application number: M020 Sunshield Moisturizing Sunscreen and Antioxidant ZINC OXIDE Oculofacial Surgery andCosmetic Laser Institute, LLC. 32c3936e-4089-edd0-e063-6294a90ad3f8 2025-12-09 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE THE AESTHETICS ACADEMY, LLC 364cf1f7-1f87-51f7-e063-6294a90a789c 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