ISA KNOX UV SUN PRO 365 Sheer Mineral Face

Product NDC
53208-003
11-digit product format
532080003
Labeler code
53208
Product ID
53208-003_32457b13-65e4-94bb-e063-6394a90a955e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
LG HOUSEHOLD & HEALTH CARE LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-10
Substance
ZINC OXIDE
Active strength
155.2 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 UV SUN PRO 365 Sheer Mineral Face
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE155.2 mg/mL

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
2eeac795-b74e-b3a3-e063-6294a90abf52Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-003-01ISA KNOX UV SUN PRO 365 Sheer Mineral Face50 mL in 1 BOTTLECREAM502
53208-003-02ISA KNOX UV SUN PRO 365 Sheer Mineral Face1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-003ISA KNOX UV SUN PRO 365 SHEER MINERAL FACE (ZINC OXIDE) CREAM [LG HOUSEHOLD & HEALTH CARE LTD.]2Current NDC, 2 package rows20250511_2eeac795-b74e-b3a3-e063-6294a90abf52.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 322 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
application number: M020
BEAST SPIT and POLISH FACE SPF-20OCTOCRYLENE, OCTISALATE, AVOBENZONESmall Batch Beauty, LLC27e5244b-4b69-4dec-9dd5-ba8b71b171b22023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLCbd60cf89-e0e9-48ad-b174-1ecf72557d9c2023-11-11WarningsExact identifier
application number: M020
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.743f3d23-0f5c-4724-9f69-411c109506e12023-11-11WarningsExact identifier
application number: M020
SEVEN MINERALS Skin Friendly SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeven Minerals NA LLC6d6b5b2a-210a-4606-9cdb-f6eec10f37e82023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Baby Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCac66ad82-a01f-4e44-92a7-b5ab5bd309222023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Daily Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLC1745dc35-648e-4315-a285-c99ebeef4f6a2023-11-11WarningsExact identifier
application number: M020
KISS MY FACE SPF-50 Face Factor Mineral SunscreenZINC OXIDEWINDMILL HEALTH PRODUCTS LLCedc2c1e7-e1a8-4b49-96df-8a94eb6a242a2023-11-11WarningsExact identifier
application number: M020
ONCODERM Rx Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEOncoderm, LLC9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae2023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF 50 SPORTOCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.f01516bf-8aed-4402-a3f9-ef11c54d46b32023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO. SPF-30OCTOCRYLENE, ZINC OXIDE, OCTISALATEThe Seaweed Bath Co.4df55434-fb9a-442d-82cf-16a4957f0a2a2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-30ZINC OXIDEProject Reef LLCb7de9ec2-6db1-4c89-b734-15c4bd5c32512023-11-11WarningsExact identifier
application number: M020
SEAWEED BATH CO Cooling Mist SPF-60 SportHOMOSALATE, OCTISALATE, ZINC OXIDEThe Seaweed Bath Co.98ccbb70-6e1a-4e92-a095-cbc4be12fcbf2023-11-11WarningsExact identifier
application number: M020
PROJECT REEF Mineral Sunscreen SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC87b9170c-956e-4aa2-9416-da00cca81b582023-11-11WarningsExact identifier
application number: M020
YOUTH CORRIDOR Soothe and Defend SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEYouth Corridor5c0873ff-8e76-48de-919d-f69794c4bd372023-11-11WarningsExact identifier
application number: M020
ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDEZITSTICKA, Inc32164318-7a7e-40b2-99da-8246c99fdbd32023-11-11WarningsExact identifier
application number: M020
SUNNY Q Broad Spectrum SPF-30ZINC OXIDESunny Q Sunscreen LLC593870fa-425c-401c-ac26-f63f4ce0298f2023-11-11WarningsExact identifier
application number: M020
BRICKELL Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC44806b83-9220-4d34-806d-20cf0a47186e2023-11-11WarningsExact identifier
application number: M020
BRICKELL Element Defense Moisturizer SPF-45OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC94be278a-3773-469b-8e40-3242d1072a3d2023-11-11WarningsExact identifier
application number: M020
I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEThirty7 LLC6ff00b6e-1cc7-4cc4-842b-4e379f75e4542023-11-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53208-003-015320800030150 mL in 1 BOTTLE50 mlHistorical
53208-003-02532080003021 BOTTLE in 1 CARTON (53208-003-02) / 50 mL in 1 BOTTLE (53208-003-01) 1 bottle2025-05-10NoNoCurrent