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 132 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373cef98-a61d-dd36-e063-6394a90a7c3b 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373d1e6c-9c32-20f5-e063-6294a90af86f 2025-12-11 Exact identifier application number: M020 Prevention 2 Acne Safe Facial Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373c0ab0-8828-542b-e063-6394a90a8633 2025-12-11 Exact identifier application number: M020 Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted ZINC OXIDE NY BEAUTY PALACE LLC 373ddad0-ed33-a233-e063-6294a90a19cd 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37263083-b24f-5a71-e063-6294a90aee7d 2025-12-11 Exact identifier application number: M020 Prevention Acne Safe Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373d4fad-141c-0904-e063-6394a90a9759 2025-12-11 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE SKINPLICITY STUDIO LLC 37265b3d-92ef-ef4a-e063-6294a90a8d95 2025-12-11 Exact identifier application number: M020 Prevention Body ZINC OXIDE NY BEAUTY PALACE LLC 373d902f-f7b6-298b-e063-6394a90a9307 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726c177-2912-a6cc-e063-6394a90a0043 2025-12-11 Exact identifier application number: M020 Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726f463-7e55-c2a2-e063-6394a90a3c51 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37617bd5-c275-aeee-e063-6394a90a214d 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37644dfd-e96d-a783-e063-6294a90a9796 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3762f132-4ab0-74ad-e063-6394a90a436c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37637e45-c6ed-12ca-e063-6294a90aeb02 2025-12-11 Exact identifier application number: M020 Face and Body Sunscreen ZINC OXIDE SCIENCE CEUTICALS, LLC 369b42f3-5203-87c4-e063-6394a90a6284 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a32097-de93-9b1d-e063-6394a90a41df 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37641f8b-0133-8bfc-e063-6294a90aac5c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3764856a-98c5-334e-e063-6394a90a629d 2025-12-11 Exact identifier application number: M020 Essential Mineral Sun Protection TITANIUM DIOXIDE, ZINC OXIDE Fern Burg 34a360b2-6798-c7e8-e063-6294a90a5cbb 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a3e268-e376-11a0-e063-6294a90a46af 2025-12-11 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