FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53208-203-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53208-203-010efc9e666f02…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
IngredientStrength
OCTISALATE4.5 g/50mL
HOMOSALATE9 g/50mL
AVOBENZONE2.7 g/50mL
OCTOCRYLENE9 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
016798a8-4275-47d0-e063-6294a90a5acaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-203-01ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN2 in 1 BOXLOTION22
53208-203-01ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN50 mL in 1 TUBELOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-203ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [LG H&H CO., LTD.]2Current NDC, 2 package rows20250125_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 208 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude CaramelOCTINOXATE, ZINC OXIDEBEL STAR S Ac4f95c1b-acbe-4bb7-e053-2995a90a91202025-06-19WarningsExact identifier
application number: M020
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-NOCTINOXATE, ZINC OXIDEBel Star S.A.d22fde8a-ba14-2cc7-e053-2a95a90a0e532025-06-19WarningsExact identifier
application number: M020
Correct and Protect Serum Broad Spectrum SPF 45ZINC OXIDEMurad, LLCdba6e01b-a8ec-4812-bbe0-e418bb0670322025-06-19WarningsExact identifier
application number: M020
Truffoire Truffle BrighteningOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.e3068ecf-0bee-4e8a-a439-4bb707a2845d2025-06-18WarningsExact identifier
application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC383de98b-65b5-4398-a876-87367dc01d0b2025-06-18WarningsExact identifier
application number: M020
CB Multi-Active Moisturizer with SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.d9557a6c-78e9-4b01-8a4b-e0eceb511c4e2025-06-18WarningsExact identifier
application number: M020
1000 Roses CC Color plus Correct Sheer Beige SPF 30ZINC OXIDEAndalou naturals2e7f3570-f710-41dd-95a0-7c0613b317a22025-06-17WarningsExact identifier
application number: M020
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30TITANIUM DIOXIDE, ZINC OXIDESKIN CARE BY SCOTTIE LLCa9afa58c-f438-48c6-bd30-eda41334df742025-06-16WarningsExact identifier
application number: M020
Wellage Real Hyaluronic Watery Glow Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHugel, Inc.37aa2f7b-afa4-5cc9-e063-6294a90ae7412025-06-16WarningsExact identifier
application number: M020
Dermaka Sunscreen SPF 42, TintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9a967cd1-9eec-4255-b14b-ac2e33e4dbf02025-06-16WarningsExact identifier
application number: M020
Elizabeth Arden Eight Hour Hydraplay SPF 40OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENERevlon Consumer Products Corp2cc74177-0f62-106e-e063-6394a90a6e282025-06-16WarningsExact identifier
application number: M020
BALI BODY SPF15 BRONZE SHIMMERING TANNINGAVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd240d4d80-641c-ac57-e063-6394a90abe752025-06-16WarningsExact identifier
application number: M020
Environ Skin Care RAD Shield Mineral Sunscreen SPF 30SUNSCREENENVIRON SKIN CARE (PTY) LTD3778547e-11a8-3b30-e063-6394a90ab5b12025-06-13WarningsExact identifier
application number: M020
Voupre Age DefenseOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.8dfaa076-c62a-47ee-bc5d-75360416fa1a2025-06-13WarningsExact identifier
application number: M020
Instantly DryTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37624bf6-4949-1b10-e063-6294a90ac4882025-06-12Exact identifier
application number: M020
silk SPF facial sunscreen fluid hybrid broad spectrum SPF 30 UVA/UVBZINC OXIDE AND HOMOSALATEOneKind.25d739bc43-d76e-9258-e053-2a95a90a3d2c2025-06-12WarningsExact identifier
application number: M020
ULTRA SHEER DAILY DEFENSE FACIAL SPF 18HOMOSALATE, OCTISALATE, AND AVOBENZONEAndalou naturals0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f2025-06-11WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm Trio The Vivids Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374e770f-75b5-08d0-e063-6394a90adf922025-06-11WarningsExact identifier
application number: M020
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
application number: M020
Vitamin C BB Beauty Balm Sheer Tint SFP 30ZINC OXIDEAndalou naturalsf423b484-2119-4c95-a0da-77bcd07303eb2025-06-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53208-203-01532080203012 TUBE in 1 BOX (53208-203-01) / 50 mL in 1 TUBE2 tube2023-07-14NoNoCurrent