ELIZABETH MOTT FACE PRIMER BROAD SPECTRUM SPF 30- 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.

----------

Elizabeth Mott Thank Me Later Face Primer Blurring Broad Spectrum SPF 30

Active Ingredients

Titanium Dioxide 3%

Zinc Oxide 3%

Purpose

Sunscreen

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.

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

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Alumina, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Eucalyptus Globulus Leaf Extract, Fragrance, Glycerin, Hexyl Laurate, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Porphyra Umbilicalis Extract, Silica, Squalane, Stearic Acid, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Water

Other Information

  • protect this product from excessive heat and direct sun.
  • may stain or damage some fabrics and surfaces.

Elizabeth Mott Thank Me Later Face Primer Blurring Broad Spectrum SPF 30

Principle Display Label

ELIZABETH MOTT  FACE PRIMER BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0573
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30.69 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30.69 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALLANTOIN (UNII: 344S277G0Z)  
CUCUMBER (UNII: YY7C30VXJT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROUS OXIDE (UNII: G7036X8B5H)  
LINSEED OIL (UNII: 84XB4DV00W)  
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
Product Characteristics
Colorbrown (Nude) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0573-330 mL in 1 TUBE; Type 0: Not a Combination Product04/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02004/18/2022
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0573) , manufacture(58443-0573) , label(58443-0573) , analysis(58443-0573)

Revised: 9/2022
Document Id: e81bb9b4-ea37-8362-e053-2995a90a90c1
Set id: e81bb9b4-ea36-8362-e053-2995a90a90c1
Version: 1
Effective Time: 20220907
 
Prime Enterprises Inc.