FDA.reportPublic FDA data

Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30

Manufacturer
Norwex Usa, Inc. | COSMAX USA. CORPORATION
Effective date
2025-11-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:17:29

Label at a glance#

ProductProtect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure6 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 40 minutes of swimming or sweating. Reapply immediately after towel drying. Children under 6 months of age: Ask a doctor. Sun Protection Measures:  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or hig...

Label contents#

Full prescribing information#

ACTIVES/MEDICINAL INGREDIENTS:% W/W- P/P:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide ............ 2.88%
Zinc Oxide........................ 6.80%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control centre or get medical help right away.

Do not use

OTC - DO NOT USE SECTION

on broken skin.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Reapply after 40 minutes of swimming or sweating.
  • Reapply immediately after towel drying.
  • Children under 6 months of age: Ask a doctor.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m.; and wear long-sleeved shirts, pants, hats and sunglasses.
  • Store in a cool dry place.
  • Do not use if safety seal is broken.
  • May stain some fabric.
  • Protect the product in this container from excessive heat and direct sun.

NON-MEDICINAL/OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Isoamyl Laurate, Caprylic/ Capric Triglyceride, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Arachidyl Alcohol, Polyglyceryl-10 Laurate, Cetearyl Olivate, Lactobacillus Ferment, Sorbitan Olivate, Argania Spinosa (Argan) Kernel Oil, Fructose, Linum Usitatissimum (Flaxseed) Seed Oil*, Ribes Nigrum (Black Currant) Seed Oil*, Rubus Chamaemorus (Cloudberry) Seed Oil*, Withania Somnifera (Ashwagandha) Root Extract, Sambucus Nigra (Elderberry) Seed Oil*, Dipotassium Glycyrrhizate, Vaccinium Vitis-Idaea (Lingonberry) Seed Oil*, Hippophae Rhamnoides (Sea Buckthorn) Fruit Extract, Betula Alba (Birch Sap Juice) Bark Extract, Ocimum Basilicum (Basil) Oil, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Geranium) Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Hydroxyacetophenone, Biosaccharide Gum-4, Stearic Acid, Bisabolol, Arachidyl Glucoside, Behenyl Alcohol, Polyhydroxystearic Acid, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Cellulose Gum, Xanthan Gum, 1,2-Hexanediol, Citric Acid, Alumina, Microcrystalline Cellulose, Styrene/Acrylates Copolymer, Potassium Sorbate, Limonene, Linalool, Citral. *Organic Ingredients/ Ingrédients organiques.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of cartonImage of labelImage of label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 51 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80971-10280971-102-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOAMYL LAURATEM1SLX00M3MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
ARGAN OIL4V59G5UW9XIACT
FRUCTOSE6YSS42VSEVIACT
FLAX SEED4110YT348CIACT
RIBES NIGRUM SEED OILGKE1188837IACT
RUBUS CHAMAEMORUS SEED OILWH495F04LZIACT
WITHANIA SOMNIFERA ROOTV038D626IFIACT
WATER059QF0KO0RIACT
SAMBUCUS NIGRA SEED OILZZV3NWA4A3IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
LINGONBERRY SEED OIL44P1VFO6KMIACT
HIPPOPHAE RHAMNOIDES FRUITAVL0R9111TIACT
BETULA PUBESCENS BARK3R504894L9IACT
BASIL OILZ129UMU8LEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAVENDER OILZBP1YXW0H8IACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
BERGAMOT OIL39W1PKE3JIIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
STEARIC ACID4ELV7Z65APIACT
LEVOMENOL24WE03BX2TIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
DOCOSANOL9G1OE216XYIACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
XANTHAN GUMTTV12P4NEEIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
ndc (package): 80971-102-01
ndc (product): 80971-102
ndc11 (package): 80971010201
spl id: 440aeb9e-256f-4e8a-e063-6394a90a9391
spl set id: f527a8c5-b05e-5f3c-e053-2995a90aa1a3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.