FDA.reportPublic FDA data

NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30

Product NDC
68577-158
11-digit product format
685770158
Labeler code
68577
Product ID
68577-158_2a26aea8-18cb-1305-e063-6294a90a16f0
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
2.88; 6.8 mg/100mg; 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
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE2.88 mg/100mg
ZINC OXIDE6.8 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
0d489154-6168-977e-e063-6394a90aa609Available 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-158-01NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF301 in 1 CARTONLOTION12
68577-158-01NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF3050 mg in 1 TUBELOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-158NORWEX PROTECT PREVENT MINERAL FACIAL SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0d489154-6168-977e-e063-6394a90aa609.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 20 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kiss My Face Purely Mineral Face Factor 50 Sunscreen SPF 50ZINC OXIDEWindmill Health Products, LLC9771aa6d-a797-42d5-919b-3bf67ef5e0402026-06-15WarningsExact identifier
application number: M020
Cellular Swiss UV Protection Veil SPF30OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONELa Prairie, Inc.dd946a3b-74b9-4ebd-b82f-0350f8f728342026-06-15WarningsExact identifier
application number: M020
365 WHOLE FOODS MARKET SPORT MINERAL SPF 30ZINC OXIDEWhole Foods Market, Inc.6caf656c-246f-469e-84f8-98f80b84c65e2026-06-15WarningsExact identifier
application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF50ZINC OXIDEMoes Group LLC543058d4-f375-d702-e063-6394a90a26402026-06-14WarningsExact identifier
application number: M020
LASSO TALLOW SUNSCREEN SPF 50ZINC OXIDEMoes Group LLC54312883-1d40-121e-e063-6294a90a247d2026-06-14WarningsExact identifier
application number: M020
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
application number: M020
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
application number: M020
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
application number: M020
Target Up and Up Ultra Light Dry-Touch SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION5411f284-f4ed-4e0e-e063-6294a90af1f62026-06-12WarningsExact identifier
application number: M020
Target Up and Up Oil Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION54141120-7682-9c05-e063-6394a90a877e2026-06-12WarningsExact identifier
application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 SheerREJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEERAtlantic Medical Products , LLC1a2ab632-6443-1aa9-e063-6394a90a0c052026-06-11WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
application number: M020
Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6c1c9ae3-650f-4cf6-bf21-d3d5229ec2fa2026-06-11WarningsExact identifier
application number: M020
Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENESICOS ET CIE3c196ac0-dc07-40ad-865c-8177c75c935a2026-06-11WarningsExact identifier
application number: M020
BelleJoss BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.53e1b5ba-45fc-e811-e063-6394a90a65ac2026-06-10WarningsExact identifier
application number: M020
MilaMiAmor SPF50 Sunscreen Lotion50mLOCTINOXATE 7.5%, ZINC OXIDE 5%Foshan Sugar Max Cosmetics CO.,Ltd5379c00f-8222-6d12-e063-6294a90a8fad2026-06-10WarningsExact identifier
application number: M020
HEY HOTTIE Shimmer dry oil mist sunscreen spf30OCTOCRYLENE,OCTINOXATEGuangdong Aimu Biological Technology Co., Ltd53f19c01-0011-bc70-e063-6294a90ab8792026-06-10WarningsExact identifier
application number: M020
SUNPLUS Solar Sheer SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESUNPLUS SKIN CARE LLC86bffd22-dded-404e-8d8e-4c54082ce50f2026-06-09WarningsExact identifier
application number: M020
Acewink SunscreenSUNSCREEN SPRAYShenzhen Qiming Biotechnology Co., Ltd.53d19fa8-6f0e-2c11-e063-6294a90abb032026-06-09WarningsExact identifier
application number: M020
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-158-01685770158011 TUBE in 1 CARTON (68577-158-01) / 50 mg in 1 TUBE1 tube2023-09-01NoNoCurrent