EPIONCE DAILY SHIELD TINTED SPF 50- titanium dioxide, zinc oxide lotion

Epionce Daily Shield by

Drug Labeling and Warnings

Epionce Daily Shield by is a Otc medication manufactured, distributed, or labeled by Episciences, Inc.. 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, regularly 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

Other information

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

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, Ferric
Oxide Red, Ferric Oxide Yellow, Ferrosofer-

ric Oxide, 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.

Questions?

Call toll free 1-866-374-6623

Epionce Daily Shield Tinted SPF 50 Principal Display Panel

INGREDIENTS AND APPEARANCE

EPIONCE DAILY SHIELD  TINTED SPF 50
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42673-005
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)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
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	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42673-005-02	1 in 1 BOX	02/27/2017
1	NDC: 42673-005-01	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/27/2017

Labeler - Episciences, Inc. (144733040)

Registrant - Episciences, Inc. (144733040)

Establishment
Name	Address	ID/FEI	Business Operations
Episciences, Inc.		144733040	manufacture(42673-005)