Home NDC 53208-203 ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN
Product NDC 53208-203
11-digit product format 532080203
Labeler code 53208
Product ID 53208-203_2c6bd22d-8a53-ace1-e063-6394a90a7594
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler LG H&H Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-14
Substance OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength 4.5; 9; 2.7; 9 g/50mL; g/50mL; g/50mL; g/50mL
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53208-203-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53208-203-01 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 ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 4.5 g/50mL HOMOSALATE 9 g/50mL AVOBENZONE 2.7 g/50mL OCTOCRYLENE 9 g/50mL
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53208-203-01 ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN 2 in 1 BOX LOTION 2 2 53208-203-01 ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN 50 mL in 1 TUBE LOTION 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53208-203 ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [LG H&H CO., LTD.] 2 Current NDC, 2 package rows 20250125_016798a8-4275-47d0-e063-6294a90a5aca.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 177 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Thrive Daily Defense Sunscreen Balm SPF30 ZINC OXIDE Thrive Natural Care, Inc 1266bd05-1971-a7f0-e063-6394a90a089c 2025-10-17 Warnings Exact identifier application number: M020 AESOP Avail Body Sunscreen Broad Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE Emeis Cosmetics Pty Ltd 2cb40521-94ed-4e76-a4e2-de1c80155bd2 2025-10-17 Warnings Exact identifier application number: M020 AESOP Avail Facial Sunscreen Broad Spectrum SPF 25 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Emeis Cosmetics Pty Ltd bff60c2f-0cc6-493b-81a0-ed35e9746146 2025-10-17 Warnings Exact identifier application number: M020 Mineral Lip Balm Pineapple ZINC OXIDE Synchronicity Spa, Inc. DBA Suntegrity 667714f6-38bc-4c94-aacc-24b46e8e59fd 2025-10-17 Warnings Exact identifier application number: M020 ELEVEN BY VENUS WILLIAMS GAME SET MATCH BODY ZINC OXIDE Eco-Chic LLC dd2fe82e-31e1-1349-e053-2995a90aa409 2025-10-16 Warnings Exact identifier application number: M020 Hello Bello Kids SPF 50 Face and Body Sunscreen Stick ZINC OXIDE Hello Bello 4127e49a-eb27-e8e2-e063-6294a90a469e 2025-10-16 Warnings Exact identifier application number: M020 ELEVEN UNRIVALED SERUM ZINC OXIDE Eco Chic, LLC f4bdacb9-bedd-c9cc-e053-2995a90a5786 2025-10-16 Warnings Exact identifier application number: M020 ELEVEN BY VENUS WILLIAMS ACE THE DAY Face ZINC OXIDE Eco-Chic LLC de438665-72d9-9b1b-e053-2a95a90ab9ef 2025-10-16 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 6bb07f16-c3a3-49e7-ae13-718bb0055873 2025-10-16 Warnings Exact identifier application number: M020 Illuminizing Blendrops Broad Spectrum SPF 40 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 124e6702-97a4-95bf-e063-6394a90afc0d 2025-10-16 Warnings Exact identifier application number: M020 Perfecting Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414c1186-6f68-3828-e063-6294a90a66cf 2025-10-16 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414c2db8-3122-60d3-e063-6394a90ae1c8 2025-10-16 Warnings Exact identifier application number: M020 DD Cream DD CREAM DERMAdoctor, Inc. 08c9a0cf-ee78-483b-e054-00144ff88e88 2025-10-16 Warnings Exact identifier application number: M020 Ciele Bronze and Protect ZINC OXIDE Ciele LLC 22003cbf-5a6d-001b-e063-6394a90aefdd 2025-10-15 Warnings Exact identifier application number: M020 Ciele Blush and Protect ZINC OXIDE Ciele 0162c891-ba2d-a78f-e063-6394a90a156c 2025-10-15 Warnings Exact identifier application number: M020 Ciele Filter and Protect TITANIUM DIOXIDE, ZINC OXIDE Ciele 0309b0ef-baca-b41d-e063-6294a90a49d7 2025-10-15 Warnings Exact identifier application number: M020 Ciele Sculpt and Protect ZINC OXIDE Ciele LLC 21ff7f78-b543-0bea-e063-6294a90aed70 2025-10-15 Warnings Exact identifier application number: M020 LATHER- DAILY DEFENSE MINERAL SPF 50 BODY SUNSCREEN ZINC OXIDE Lather, Inc. 3158a2d7-0db5-f5bf-e063-6294a90a3126 2025-10-15 Warnings Exact identifier application number: M020 LATHER- DAILY DEFENSE MINERAL SPF 50 ZINC OXIDE Lather, Inc. 81cf57b0-6072-432f-b421-7d1a708da1c4 2025-10-15 Warnings Exact identifier application number: M020 Ciele Glow and Protect ZINC OXIDE Ciele Cosmetics 27310d47-de1b-2149-e063-6394a90abe83 2025-10-15 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 53208-203-01 53208020301 2 TUBE in 1 BOX (53208-203-01) / 50 mL in 1 TUBE 2 tube 2023-07-14 No No Current