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 149 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8208b-7328-1891-e063-6294a90abdd92025-12-08Exact identifier
application number: M020
Protect Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b8dedc-0575-9819-e063-6394a90afebf2025-12-08Exact identifier
application number: M020
Protect Mineral Stick ClearTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bfa392-dfec-bd8a-e063-6394a90acffa2025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.34b9d646-e049-6781-e063-6294a90ab1012025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen Non-TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be70d5-aefe-fd6f-e063-6394a90ac4362025-12-08Exact identifier
application number: M020
Protect 20 Zinc Oxide Mineral Sunscreen TintedZINC OXIDEMelinda Menezes, M.D., Inc.35be17ce-c3a7-fd59-e063-6394a90ad11d2025-12-08Exact identifier
application number: M020
Protect Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35c044a6-90be-55f8-e063-6294a90aad482025-12-08Exact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUMOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ed877-2926-1fd9-e063-6394a90aa1532025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMELOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f1ad4c-af9a-c998-e063-6294a90a15db2025-12-08WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TANOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENEAekyung Industrial Co., Ltd.11f37a57-47ce-4175-e063-6394a90a92ee2025-12-08WarningsExact identifier
application number: M020
RECHARGE Protect BlurTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCc787e3b9-33b1-4c47-95bd-b14cf65589382025-12-08WarningsExact identifier
application number: M020
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
application number: M020
Inblair Elevate SPF15 MoisturizerINBLAIR ELEVATE SPF15 MOISTURIZERGuangzhou Fantesy Biotechnology Co.,Ltd4567d413-d8cc-677b-e063-6294a90a1a422025-12-07WarningsExact identifier
application number: M020
HANCHOBIT Radiant Pink Tone Up Sun CreamTITANIUM DIOXIDEHANCHOYEANBIOTEC Co.,Ltd.45685047-166d-8af5-e063-6294a90aa7be2025-12-07WarningsExact identifier
application number: M020
EELHOE Moisturiser Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.454004c9-07fa-64ad-e063-6394a90a0c8a2025-12-06WarningsExact identifier
application number: M020
OUHOE Daily Exposure Lightweight SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.454301b6-21a6-6153-e063-6294a90a13662025-12-06WarningsExact identifier
application number: M020
OUHOE Cotton Soft Sun StickTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4543a43e-acf7-6759-e063-6394a90a2f532025-12-06WarningsExact identifier
application number: M020
OUHOE Centella Daily SunTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4544f3a3-8c52-ea54-e063-6394a90a7a9c2025-12-06WarningsExact identifier
application number: M020
EELHOE All Day Light Sunscreen MistTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.45323ca3-c706-dcb5-e063-6394a90a96f72025-12-05WarningsExact identifier
application number: M020
EELHOE Airy SunstickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.45328c13-31ae-3bd2-e063-6394a90a814f2025-12-05WarningsExact 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