INFINITEK PARIS BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion 
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Infinitek Paris Tinted Mineral Face Sunscreen Lotion Broad Spectrum SPF 50

Active Ingredients

Titanium Dioxide 4%

Zinc Oxide 4%

Uses

Purpose

Sunscreen

Warnings

For external use only

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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

Directions

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

support@infinitekparis.com

INACTIVE INGREDIENTS

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

Principle Display Label

INFINITEK PARIS  BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0436
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE41.84 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE41.84 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)  
ALLANTOIN (UNII: 344S277G0Z)  
LINSEED OIL (UNII: 84XB4DV00W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CUCUMBER SEED (UNII: BT3S9L53JK)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
Product Characteristics
Colorbrown (Light Tan) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0436-350 mL in 1 TUBE; Type 0: Not a Combination Product05/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/20/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0436) , manufacture(58443-0436) , label(58443-0436) , analysis(58443-0436)

Revised: 10/2021
Document Id: cf44408e-263b-37cd-e053-2995a90a531f
Set id: cf445185-3336-155a-e053-2a95a90ae57a
Version: 1
Effective Time: 20211026
 
Prime Enterprises Inc.