FDA.reportPublic FDA data

Infinitek Paris Tinted Mineral Face Sunscreen Lotion Broad Spectrum SPF 50

Manufacturer
Prime Enterprises Inc.
Effective date
2021-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:30:36

Label at a glance#

ProductInfinitek Paris Broad Spectrum SPF 50 Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see directions ) decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4%

Zinc Oxide 4%

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.
  • 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 10:00 a.m. to 2:00 p.m.
  • Wear long-sleeved shirt, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

support@infinitekparis.com

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Iron Oxides, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Physalis Angulata Extract, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Rosa Canina Seed Oil, Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Infinitek Paris Tinted Mineral Sunscreen Broad Spectrum SPF 50 - 50 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-043658443-0436-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675IACT
ROSA CANINA SEED OILMHT97MG5P8IACT
ALLANTOIN344S277G0ZIACT
LINSEED OIL84XB4DV00WIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CUCUMBER SEEDBT3S9L53JKIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALUMINUM OXIDELMI26O6933IACT
STEARIC ACID4ELV7Z65APIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
PHYSALIS ANGULATAW4TKW9D5GGIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
HEXYL LAURATE4CG9F9W01QIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
cf44408e-263b-37cd-e053-2995a90a531fcf445185-3336-155a-e053-2a95a90ae57a2021-10-26WarningsExact identifier
spl id: cf44408e-263b-37cd-e053-2995a90a531f
spl set id: cf445185-3336-155a-e053-2a95a90ae57a

Reported adverse events (FAERS/openFDA)#

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