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 182 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vertra Pearl White Face Stick SPF 50 PADIMATE O, TITANIUM DIOXIDE Eai-jr 286, Inc b69a75e0-8724-35ae-e053-2a95a90a5f34 2025-10-07 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE EAI-JR 286, Inc. b9ea12e8-6ed9-d805-e053-2a95a90aa107 2025-10-07 Warnings Exact identifier application number: M020 SPF50 Sunscreen SUNSCREEN KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD b3cde609-7d62-2ac7-e053-2a95a90a26b3 2025-10-07 Exact identifier application number: M020 Summer Face Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUMMER GELEE LLC fe256ff4-cb92-4262-8ab9-7cc912e0af22 2025-10-06 Warnings Exact identifier application number: M020 Sun Veil Broad Spectrum SPF50 ZINC OXIDE MONAT GLOBAL CORP 3ba28de7-74a2-5cde-e063-6394a90add26 2025-10-06 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE Toshiki Pigment Co., Ltd. b9eba15f-493a-43c9-e053-2995a90a0451 2025-10-06 Warnings Exact identifier application number: M020 Apple Lip Balm with Aloe Vera BROAD SPECTRUM SPF 15 SUNSCREEN LIP BALM Durvet, Inc. 6dcbb2cd-e690-4970-8cf1-08ca539d3602 2025-10-06 Warnings Exact identifier application number: M020 PURE SOL SPF 50 Daily Moisturizer ZINC OXIDE Brand 2022b LLC 4051506c-fc13-cd22-e063-6394a90a977e 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 30 Mineral Whipped Sunscreen (Shimmer) ZINC OXIDE Brand 2022b LLC 4051ced5-85cf-6211-e063-6394a90a09fc 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 30 Mineral Whipped Sunscreen ZINC OXIDE Brand 2022b LLC 4051d241-6890-2b06-e063-6294a90aa09d 2025-10-04 Warnings Exact identifier application number: M020 PURE SOL SPF 37 Tinted Moisturizer ZINC OXIDE TITANIUM DIOXIDE Brand 2022b LLC 4052c4e4-2105-80c0-e063-6294a90af41d 2025-10-04 Warnings Exact identifier application number: M020 PLAY Antioxidant Body Mist SPF 50 - Vanilla Orchid AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3f7a9722-d211-e861-e063-6294a90a6cdc 2025-10-02 Warnings Exact identifier application number: M020 Kids Mineral Sunscreen SPF50 SUNSCREEN Hello Bello 01cc554b-9241-d891-e063-6394a90a8450 2025-10-02 Warnings Exact identifier application number: M020 HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVB SUNSCREEN SPF 50 IHerb, LLC 3cab1598-5ef3-df73-e063-6394a90ab1e2 2025-10-01 Warnings Exact identifier application number: M020 Moisturizing Rich Sunscreen SPF 30 ZINC OXIDE Good Molecules, LLC 36c3ba26-ca25-7498-e063-6294a90a47fc 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 Shade 1 ZINC OXIDE Dime Beauty Co, LLC 07104cbf-0446-a053-e063-6394a90ab41f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 ZINC OXIDE Dime Beauty Co, LLC 07503a1f-d530-e3bb-e063-6294a90a8ae3 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC e38deed3-e1e2-0b1d-e053-2a95a90a547f 2025-10-01 Warnings Exact identifier application number: M020 Wonderscreen Tinted Broad Spectrum SPF 30 ZINC OXIDE Dime Beauty Co, LLC f2a59fa4-f19c-a15f-e053-2a95a90a6ace 2025-10-01 Warnings Exact identifier application number: M020 Bronzing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 414b88ca-a3df-5e42-e063-6294a90a69ba 2025-10-01 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