ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN

Product NDC
53208-211
11-digit product format
532080211
Labeler code
53208
Product ID
53208-211_2c6bd652-2ee6-b9c5-e063-6294a90aee0a
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
LG H&H Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-01
Substance
ZINC OXIDE
Active strength
15.52 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 packagepackage53208-211-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53208-211-010efc9e666f02…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 MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15.52 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1166cb4-b471-7043-e053-2a95a90a7fa7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-211-01ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN50 mL in 1 TUBECREAM502
53208-211-01ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN2 in 1 BOXCREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-211ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN (ZINC OXIDE) CREAM [LG H&H CO., LTD.]2Current NDC, Legacy NDC, 2 package rows20250125_f1166cb4-b471-7043-e053-2a95a90a7fa7.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 141 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dc6e23-ecca-ed0b-e063-6294a90a79512025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddc3d7-76df-3344-e063-6294a90a65ae2025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddf80c-8496-0f47-e063-6394a90afc182025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30dfa973-3217-1e18-e063-6294a90a8d412025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30df0039-4dc1-7355-e063-6394a90ae8002025-12-09WarningsExact identifier
application number: M020
Advanced Lip GuardTITANIUM DIOXIDE, ZINC OXIDEADVANCED DERMATOLOGY32e66ff3-ae1a-4a2a-e063-6294a90a79632025-12-09Exact identifier
application number: M020
Skin Tone Defender 20% Zinc OxideZINC OXIDECali Skin Care LLC308c711d-4c3e-1208-e063-6394a90a9cc22025-12-09WarningsExact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEADVANCED DERMATOLOGY32d781ca-7993-9875-e063-6294a90a5c262025-12-09Exact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEAdvanced Dermatology32e6c080-6ce3-8d99-e063-6294a90ac1bc2025-12-09Exact identifier
application number: M020
StriVectin multi-action Super-C SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.b299df12-fbdd-437b-9bfa-4846e361725a2025-12-09WarningsExact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f1e019-32c4-b733-e063-6394a90aca282025-12-09Exact identifier
application number: M020
RADIANCEZINC OXIDEL.S. MOORE LLC37f254cb-9de5-8f67-e063-6294a90a4e282025-12-09Exact identifier
application number: M020
StriVectin Advanced Retinol Daily Repair Moisturizer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.cfbdbba8-a739-fd32-e053-2a95a90a6f312025-12-09WarningsExact identifier
application number: M020
Hint of TintZINC OXIDEL.S. MOORE LLC37f20c14-070e-4f86-e063-6294a90ad4c22025-12-09Exact identifier
application number: M020
Hint of TintZINC OXIDEL.S. MOORE LLC37f330a0-790a-1656-e063-6294a90a691c2025-12-09Exact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f2e363-e85f-f601-e063-6294a90ab1202025-12-09Exact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL MOORE AESTHETICS37f1ac8c-3bfb-10da-e063-6294a90a8ca82025-12-09Exact identifier
application number: M020
RoC Multi Correxion Revive and Glow Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare40d4cfeb-fb00-801e-e063-6394a90ada6b2025-12-09WarningsExact identifier
application number: M020
RADIANCEZINC OXIDEL.S. MOORE LLC37f2b104-0213-c88c-e063-6294a90a42472025-12-09Exact identifier
application number: M020
Mineral Sunscreen Moisturizing Lightly TintedZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC3350c673-2afd-a00a-e063-6294a90aa1962025-12-09Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53208-211-01532080211012 TUBE in 1 BOX (53208-211-01) / 50 mL in 1 TUBE2 tube2022-12-010000-00-00NoNoCurrent