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 32 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frase Skin SPF 30 Face Sunscreen Activated Vitamin D TechnologyAVOBENZONE, OCTISALATE, OCTOCRYLENEFrase Skin PTY LTDd904fd23-a3a1-4564-8eec-13a4c96e23f72026-05-12WarningsExact identifier
application number: M020
Hawaii Sol Natural Non-Nano Sunscreen SPF 50ZINC OXIDECaribbean Sol International, LLC24678326-547f-427d-a481-d8c40380e30a2026-05-12WarningsExact identifier
application number: M020
Caribbean Sol Natural Non-Nano Sunscreen SPF 50ZINC OXIDECaribbean Sol International, LLC20aadcf6-16a3-4344-837b-b91ba8753fb02026-05-12WarningsExact identifier
application number: M020
Cancer Council Daily Face Moisturizer SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1b4333b8-5747-c591-e063-6294a90a99242026-05-12WarningsExact identifier
application number: M020
Lather Daily Defense Mineral SPF 45 Facial SunscreenZINC OXIDELather, Inc.50c732a0-b282-d61b-e063-6294a90aa76b2026-05-12WarningsExact identifier
application number: M020
Hampton Sun SPF50 Mineral Face SunscreenHOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%S&C Hampton Sun LLCf1c5310b-c43b-475d-8a50-d55759ad31642026-05-12WarningsExact identifier
application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
application number: M020
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
application number: M020
Stellar Mineral Glow Guard Sunscreen Broad Spectrum SPF 50ZINC OXIDEStellar Beauty Co.0f7ee8c6-3af2-42a2-b341-3e0da42c7c932026-05-11WarningsExact identifier
application number: M020
Frase Skin SPF 50 Activated Vitamin D Technology CoolAVOBENZONE, OCTISALATE, OCTOCRYLENEFrase Skin PTY LTD0a5cc927-0fd3-4c8f-b847-a274f6eb09fb2026-05-11WarningsExact identifier
application number: M020
Miami Beach Bum SPF 30 Bodyguard Face Body Mineral SunscreenZINC OXIDEMiami Beach Bum3b778530-9af0-48eb-bd91-d9ac99f2983f2026-05-11WarningsExact identifier
application number: M020
Walgreens SPF 60 Melt-in Milk SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalgreens345955ea-f37a-8629-e063-6294a90aa7cc2026-05-11WarningsExact identifier
application number: M020
DERMATONE SPF50 SunscreenAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Dermatone Labs LLC4dc81593-4790-403f-9d49-6569bcd0fea22026-05-11WarningsExact identifier
application number: M020
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
application number: M020
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact identifier
application number: M020
ChapStick Moisturizer Original SPF 15SPF 15 SKIN PROTECTANTSuave Brands Co., LLC47bfa8ea-4d8d-cd13-e063-6394a90a71aa2026-05-11WarningsExact identifier
application number: M020
EELHOE SunscreenTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5196ccb0-4515-7e40-e063-6394a90a09bd2026-05-11WarningsExact identifier
application number: M020
Mediheal Madecassoside Moisture Sun SerumHOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLE7400547c66535-8287-9b74-e063-6394a90ac3b62026-05-10WarningsExact identifier
application number: M020
SPF 30 SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLCaf56f16a-2643-4bfc-9e05-dfba79cdab8a2026-05-08WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Cool GlowZINC OXIDEIris and Romeo514f7d70-7b8b-0992-e063-6394a90a1e982026-05-08WarningsExact 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