FDA.reportPublic FDA data

KOPARI Antioxidant Face Shield Mineral SPF 30

Product NDC
68577-154
11-digit product format
685770154
Labeler code
68577
Product ID
68577-154_2a26a71f-204b-0a8b-e063-6394a90aaba8
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
Substance
ZINC OXIDE
Active strength
14.4 mg/100mg
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
KOPARI Antioxidant Face Shield Mineral SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE14.4 mg/100mg

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
0d43e22c-5e3d-df90-e063-6294a90aac2bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-154-01KOPARI Antioxidant Face Shield Mineral SPF 3045 mg in 1 BOTTLE, PUMPLOTION452
68577-154-01KOPARI Antioxidant Face Shield Mineral SPF 301 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-154KOPARI ANTIOXIDANT FACE SHIELD MINERAL SPF 30 (ZINC OXIDE) LOTION [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0d43e22c-5e3d-df90-e063-6294a90aac2b.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 316 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5169b10e-5a8d-479a-a6a8-1e7a13cb70c42023-12-12WarningsExact identifier
application number: M020
Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20TITANIUM DIOXIDEBoscia LLCf76166f1-e987-4eaf-8192-14dc08c481f72023-12-12WarningsExact identifier
application number: M020
Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBoscia LLC2a6b507f-0967-46e1-8360-0003772f1bdb2023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Oily SkinOCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporated97bd2033-2cf0-4e5d-81e2-c453a1e3a65e2023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 01TITANIUM DIOXIDE3LAB, Inc.703dc828-24b4-4f04-9f2c-4a2edfdf46322023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 02TITANIUM DIOXIDE3LAB, Inc.7c6c7062-91f7-4304-98c3-f77967a2d3292023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Dry SkinOCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporated8a75dde9-8dcb-4f4a-b9df-88338bd2a4402023-12-12WarningsExact identifier
application number: M020
Everyday Facial Moisturizer And Sunscreen SPF 20ZINC OXIDE714 Essentials LTD3a29018b-8103-4983-b0c5-5f340775a05d2023-12-12WarningsExact identifier
application number: M020
Likewise Hand Moisturizer - Sun Protectant SPF 50OCTINOXATE, OCTISALATE, ZINC OXIDELikewise Incorporateda54f0854-c55e-4a46-9084-16cb1be0f6812023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 01TITANIUM DIOXIDE3LAB, Incbd39d2fb-8326-4e19-b634-7a7308313d8a2023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 03TITANIUM DIOXIDE3LAB, Inc19884289-edb2-4d18-bd62-873533b94a102023-12-12WarningsExact identifier
application number: M020
Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.92dc1a86-590e-4144-9d30-172645e631402023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT BB SPF 40 Broad Spectrum 02TITANIUM DIOXIDE3LAB, Incbf4419b9-408d-469a-aa15-bbf419632f022023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT Sunscreen SPF 50 Plus Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE3LAB, Inc2bee6b87-c889-4ea1-87ad-e28949bcb67a2023-12-12WarningsExact identifier
application number: M020
Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily SkinTITANIUM DIOXIDE, ZINC OXIDELikewise Incorporated28b8c519-8417-427e-8d4f-94da44a69d9f2023-12-12WarningsExact identifier
application number: M020
BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c795f0-63bc-3033-e053-2995a90a55ab2023-12-12WarningsExact identifier
application number: M020
Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.c06ecc56-2044-4396-8acd-6d18af9b984c2023-12-12WarningsExact identifier
application number: M020
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.f5c7b7ce-b3ed-3e96-e053-2995a90a8ea92023-12-12WarningsExact identifier
application number: M020
Milani SPF BFF 30 PrimerAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONENew Milani Group, LLCc7a1f2a7-d299-2116-e053-2995a90ad8c52023-12-12WarningsExact identifier
application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENew Milani Group, LLC8f52f614-1cfe-4ef0-8cb6-37afbfddf44c2023-12-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68577-154-01685770154011 BOTTLE, PUMP in 1 CARTON (68577-154-01) / 45 mg in 1 BOTTLE, PUMP2023-06-01NoNoCurrent