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 196 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Earth Mama Tinted Mineral Sunscreen SPF 40 ZINC OXIDE Eleeo Brands LLC 3c455d29-df4e-f4d5-e063-6394a90a97ba 2025-08-13 Warnings Exact identifier application number: M020 Baby Bum Mineral 50 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3c470ff8-37d6-a729-e063-6294a90aa525 2025-08-13 Warnings Exact identifier application number: M020 Sun Bum 50 Mineral Sunscreen 1 OZ ZINC OXIDE Sun Bum, LLC 3c483d04-8942-5269-e063-6294a90a3881 2025-08-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE/OCTOCRYLENE/OXYBENZONE Edgewell Personal Care Brands LLC 3c49c623-47c6-4dc9-e063-6294a90a0096 2025-08-13 Warnings Exact identifier application number: M020 100% MINERAL SUNSCREEN 100% MINERAL SUNSCREEN Guangzhou Pallas Cosmetics Co.,Ltd. 3c4a3b41-9183-3835-e063-6394a90aea61 2025-08-13 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 FAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4443d4e6-bdc9-4547-9189-e94e9e0bdd2d 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC Red Correct Color Correcting SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L a6cd16cc-5fe3-41b5-b724-83e469cd4d5e 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 BRONZE OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 4aa12cf0-0c48-4b40-9c9a-bd50523cce8a 2025-08-12 Warnings Exact identifier application number: M020 ERBORIAN CC CREME Color Correcting SPF 25 MEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 5bdaa149-47aa-40ac-b17a-ea6d29099862 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1dda967c-2d69-8948-e063-6294a90ad2a4 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 24e9a9b8-41ba-123a-e063-6394a90a73cb 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1dd9fe59-9e40-fd06-e063-6394a90a4ca2 2025-08-12 Warnings Exact identifier application number: M020 Coola Anti-Aging Hand Cream Sunscreen AVOBENZONE, OCTOCRYLENE, OCTISALATE COOLA LLC 3c2fbf10-d68e-c601-e063-6294a90a09a3 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 15mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 24ea340a-06cd-b085-e063-6394a90adff9 2025-08-12 Warnings Exact identifier application number: M020 AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE Aekyung Industrial Co., Ltd. 15536331-fec5-4daa-824d-2e32d63e6452 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1ddad045-7703-ea7e-e063-6394a90a2a5a 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 15mL SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 0cf45fbf-b257-f16a-e063-6294a90a8794 2025-08-12 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 40mL SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 1ddb1f53-69dd-643a-e063-6394a90ad600 2025-08-12 Warnings Exact identifier application number: M020 Earth Mama Lady Face Mineral Sunscreen - Medium/Dark Tint Broad Spectrum SPF 40 ZINC OXIDE Earth Mama Angel Baby LLC 908c41fd-0496-4237-813b-1135e10ae0c5 2025-08-12 Warnings Exact identifier application number: M020 Earth Mama Baby Mineral Sunscreen SPF 40 ZINC OXIDE Earth Mama Angel Baby, LLC 74475fba-4cdd-4b27-8ea4-646f4016580c 2025-08-12 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