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

Harken Derm High Performance Sunscreen by

Drug Labeling and Warnings

Harken Derm High Performance Sunscreen by is a Otc medication manufactured, distributed, or labeled by Harken Derm LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HARKEN DERM HIGH PERFORMANCE SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71892-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.048 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.093 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71892-000-00	100 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2018	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2018	07/31/2020

Labeler - Harken Derm LLC (080891015)