HARKEN DERM HIGH PERFORMANCE SUNSCREEN- titanium dioxide, zinc oxide lotion 
Harken Derm LLC

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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Harken Derm High Performance Sunscreen

Active ingredients

Titanium Dioxide 4.8%
Zinc Oxide 9.3%

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

Stop use and ask a doctor if

  • rash occurs

When using this product

  • keep out of eyes.
    Rinse with water to remove.

Keep out of reach of children.

If product is 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 two 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, regularyl 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.
    • wear long-sleeved shirts, pants, hats and
      sunglasses

Inactive ingredients

Cyclomethicone 5, Water, Dimethicone
Crosspolymer (450000 MPA.S At 12% In
Cyclopentasiloxane), Butylene Glycol,
Cetyl PEG/PPG-10/1 Dimethicone (HLB 2),

Polymethylsilsesquioxane (4.5 Microns),

Caprylyl Trisiloxane, PEG-10 Dimethicone
(600 CST), Argan Oil, Glycerin, Disteardi-

monium Hectorite, Isododecane, .ALPHA.-

Tocopherol Acetate, Aluminum Oxide, Apple,

Caprylyl Glycol, Ethylhexylglycerin, Helianthus Annuus Flowering Top,

Hexylene Glycol, Lauryl Polyglyceryl-3 Poly-

dimethylsiloxyethyl Dimethicone, Levomenol,

Methicone (20 CST), PEG/PPG-18/18 Di-

methicone, Phenoxyethanol, Propylene

Carbonate, Rice Bran, Rosemary, Silicon

Dioxide, Sodium Chloride, Tocopherol, Tri-

ethoxycaprylylsilane.

Other information

  • protect the product in this container from
    excessive heat and direct sun

Questions?

Please visit harkenderm.com or call toll-free (833) Dr H Derm or (833-374-3376)

Harken Derm High Performance Sunscreen Principal Display Panel

Harken Derm High Performance Sunscreen Tube Front

HARKEN DERM HIGH PERFORMANCE SUNSCREEN 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71892-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.048 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.093 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERIN (UNII: PDC6A3C0OX)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ISODODECANE (UNII: A8289P68Y2)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
RICE BRAN (UNII: R60QEP13IC)  
ROSEMARY (UNII: IJ67X351P9)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
APPLE (UNII: B423VGH5S9)  
ARGAN OIL (UNII: 4V59G5UW9X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LEVOMENOL (UNII: 24WE03BX2T)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71892-000-00100 g in 1 TUBE; Type 0: Not a Combination Product06/01/201807/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201807/31/2020
Labeler - Harken Derm LLC (080891015)

Revised: 12/2018
 
Harken Derm LLC