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 137 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ProtectME Tinted Mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE PUREFECTION LA, INC. 33dccd5d-8db1-f699-e063-6394a90a59a2 2025-12-10 Exact identifier application number: M020 Protect ME Non Tinted Mineral SPF 40 ZINC OXIDE PUREFECTION LA, INC. 34a2d716-b853-752e-e063-6394a90a52e2 2025-12-10 Exact identifier application number: M020 Tinted Mineral Moisturizing Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ABOUT FACE AESTHETICS, INC. 364728b4-e0ff-8466-e063-6394a90a0089 2025-12-10 Exact identifier application number: M020 tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin & Bare It LLC 35d42661-e511-1dfc-e063-6294a90a9ed7 2025-12-10 Exact identifier application number: M020 non-tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin & Bare It LLC 35d3ef95-621c-f193-e063-6294a90ac3ee 2025-12-10 Exact identifier application number: M020 face Plus body sunscreen tinted ZINC OXIDE Skin & Bare It LLC 35d45df5-e9bf-1a08-e063-6294a90ae04f 2025-12-10 Exact identifier application number: M020 face Plus body sunscreen non-tinted ZINC OXIDE Skin & Bare It LLC 361ef750-0f0e-bd01-e063-6294a90a0020 2025-12-10 Exact identifier application number: M020 bare skin smooth mineral tint ZINC OXIDE Skin & Bare It LLC 361f2933-73d5-a9d7-e063-6394a90abb3c 2025-12-10 Exact identifier application number: M020 Smoothing Mineral Sunscreen Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE DANIEL BEHROOZAN MD A MEDICAL CORPORATION 32721b87-aef1-d759-e063-6394a90a40d3 2025-12-10 Exact identifier application number: M020 Non-Tinted Mineral Stick TITANIUM DIOXIDE, ZINC OXIDE Shelley Bennett Skincare 326e9a14-5fb6-6a6e-e063-6294a90adece 2025-12-10 Exact identifier application number: M020 3-in-1 Daily Vanishing Tinted Sunscreen Cream ZINC OXIDE Shelley Bennett Skincare 325dae60-01cc-a120-e063-6294a90a2ef2 2025-12-10 Exact identifier application number: M020 Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE Shelley Bennett Skincare 326e49b8-e21c-0df0-e063-6394a90a2ebc 2025-12-10 Exact identifier application number: M020 Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE SHELLEY BENNET SKINCARE 325df1f8-1678-c07c-e063-6294a90a96fb 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bafa0b-d253-c263-e063-6394a90ad1e4 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35ba578f-a842-7eec-e063-6394a90a1165 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb3b36-3886-ea8e-e063-6394a90a5257 2025-12-10 Exact identifier application number: M020 Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bc3994-1f72-2bbf-e063-6294a90ac2f1 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bccadf-6fc8-abd0-e063-6294a90aaa2e 2025-12-10 Exact identifier application number: M020 Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb9341-355f-4910-e063-6294a90a8c15 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bd61ff-0d66-a9b3-e063-6394a90ad940 2025-12-10 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