NF SKIN SPF 30 BROAD SPECTRUM MOISTURIZER- 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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NF Skin Lux MD SPF 30 Broad Spectrum Moisturizer

Active Ingredients

Titanium Dioxide 3%

Zinc Oxide 3%

Purpose

Sunscreen

Uses

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other Information

Questions or Comments?

LUX MD Skin Care Salt Lake City,UT 84117 / luxmd17@gmail.com / www.lux-md.com

NF Skin - LuxMD Skin Care SPF 30 Broad Spectrum Moisturizer

Principle Display Label

NF SKIN  SPF 30 BROAD SPECTRUM MOISTURIZER
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0576
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30.9 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALLANTOIN (UNII: 344S277G0Z)  
CUCUMBER (UNII: YY7C30VXJT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LINSEED OIL (UNII: 84XB4DV00W)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
Colorwhite (White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0576-350 mL in 1 TUBE; Type 0: Not a Combination Product06/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02006/21/2022
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0576) , manufacture(58443-0576) , label(58443-0576) , analysis(58443-0576)

Revised: 9/2022
Document Id: e922be05-48ee-ea35-e053-2a95a90a8ff4
Set id: e922b539-bb0d-6e57-e053-2995a90a8aea
Version: 1
Effective Time: 20220920
 
Prime Enterprises Inc.