FDA.reportPublic FDA data

Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30

Product NDC
80971-102
11-digit product format
809710102
Labeler code
80971
Product ID
80971-102_440aeb9e-256f-4e8a-e063-6394a90a9391
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Norwex Usa, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
28.8; 68 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE28.8 mg/mL
ZINC OXIDE68 mg/mL

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
f527a8c5-b05e-5f3c-e053-2995a90aa1a3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80971-102-012023-08-09C16284748780-10191ceaa-66ad-198a-e063-dbdaa90aec3eProtect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30
80971-102-012023-07-28C16284748780-10191ceaa-66ad-198a-e063-dbdaa90aec3eProtect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80971-102-01Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF3050 mL in 1 TUBECREAM507
80971-102-01Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF301 in 1 CARTONCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80971-102PROTECT PREVENT DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [NORWEX USA, INC.]6Current NDC, 2 package rows20250101_f527a8c5-b05e-5f3c-e053-2995a90aa1a3.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
80971-102-01809710102011 TUBE in 1 CARTON (80971-102-01) / 50 mL in 1 TUBE1 tube2023-01-01NoNoCurrent