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 164 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15AVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLCe36efd74-11c2-4850-9529-1c88b7364a332025-11-12WarningsExact identifier
application number: M020
TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80minAVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLC22a40d93-ca67-4b7d-a95c-22f52cd6d2972025-11-12WarningsExact identifier
application number: M020
Practical Alchemy Hydrating SPF 30ZINC OXIDEOver Here, LLC2f07df5b-dbd4-494c-a7cf-55843fb4d7c22025-11-12WarningsExact identifier
application number: M020
Dr Lift SPF 50 Mineral Sunscreen StickZINC OXIDESpa de Soleil436fdf4f-11db-7c5b-e063-6294a90a87312025-11-12WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc3676aa91-c90d-4a7a-b02e-d5b35304a04d2025-11-12WarningsExact identifier
application number: M020
HYDRATING GLOW MIST SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTDdf3bd18d-63b4-460f-bf1c-115ad35edd962025-11-11WarningsExact identifier
application number: M020
Zinka Clear Zinc Oxide SunscreenOCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONEZinka, Inc.7b097f5e-8127-49e6-8a77-4ee1fded5ff12025-11-11WarningsExact identifier
application number: M020
Total Sun ProtectionOCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDECosmed Dermaceuticals, Inc.dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f2025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF15HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC1a1c17c4-4912-4573-9f59-cbd14a014cb42025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF30HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC14f65b3d-90bf-4689-aa6e-879e06153db92025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF50HOMOSALATE, ZINC OXIDE, OCTOCRYLENEQS Key West Aloe, LLCb4fc7a51-a163-4057-8790-f2111668ec672025-11-11WarningsExact identifier
application number: M020
Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEPILLOWTALKDERM LLC30e10a62-8430-649b-e063-6394a90a97eb2025-11-11WarningsExact identifier
application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTEDTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.279a5214-79b2-44e9-b003-378d0b9923952025-11-11WarningsExact identifier
application number: M020
Tinted Moisturizer SPF 46 Universal TintZINC OXIDE, OCTINOXATEDrmtlgy, LLC5304b568-f891-4094-9182-363ae7bcfbe42025-11-11WarningsExact identifier
application number: M020
C Lip Serum Mineral Broad Spectrum SPF 30SUNSCREENSimply Active Cosmetics323661a6-3602-1ce2-e063-6394a90a8e912025-11-10WarningsExact identifier
application number: M020
buttah Tinted Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEButtah Enterprises, LLC.43458152-0775-dd9c-e063-6394a90a61402025-11-10WarningsExact identifier
application number: M020
Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 gZINC OXIDEAspen Glow Cosmetics, LLC142eda44-76e1-7960-e063-6394a90a9ad62025-11-10WarningsExact identifier
application number: M020
TriLipiderm Broad Spectrum SPF 30BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENETriLipid Research Institute, LLC617fc696-c2a1-4855-bafb-0454e64971012025-11-10WarningsExact identifier
application number: M020
TriLipiderm Protective DayHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENETriLipid Research Institute, LLC66726c2b-27e9-5dd1-e053-2991aa0a1ba72025-11-10WarningsExact identifier
application number: M020
Eucerin Sensitive Mineral SPF 50 SunscreenZINC OXIDEBeiersdorf Inccdb25154-e4e3-efc7-e053-2a95a90a2df62025-11-10WarningsExact 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