EPIONCE SKIN BARRIER REPAIR KIT- homosalate, octisalate, zinc oxide lotion

Epionce Skin Barrier Repair Kit by

Drug Labeling and Warnings

Epionce Skin Barrier Repair Kit by is a Otc medication manufactured, distributed, or labeled by Episciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 9.95%

Octisalate 5.0%

Zinc Oxide 10.1%

Purpose

Sunscreen

Uses

• helps prevent sunburn

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

Inactive ingredients

Alkyl (C12-15) Benzoate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Butylene Glycol, Caprylyl Glycol, Caprylyl Trisiloxane, Cetostearyl Alcohol, Date, Dimethicone, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrogenated Polybutene (1300 MW), Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate, Copolymer (45000 MPA.S AT 1%), Linseed Oil, Malic Acid, Meadowfoam Seed Oil, Phenoxyethanol, Polyhydroxystearic Acid (2300 MW), Polysorbate 80, Safflower Oil, Steareth-2, Steareth-21, Triethoxycaprylylsilane, Trimethylsiloxysilicate (M/Q 0.66), Water.

Other information

• protect this product from excessive heat and direct sunlight

Questions?

Call toll free 1-866-374-6623

Skin Barrier Repair Kit Package Insert

Package Insert Side A:

Package Insert Side B:

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EPIONCE SKIN BARRIER REPAIR KIT 
homosalate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42673-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.095 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.101 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DATE (UNII: H3O7QI5HY7)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
LINSEED OIL (UNII: 84XB4DV00W)
MALIC ACID (UNII: 817L1N4CKP)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SAFFLOWER OIL (UNII: 65UEH262IS)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42673-004-02	1 in 1 BOX	04/06/2009	04/30/2020
1	NDC: 42673-004-01	30 g in 1 TUBE; Type 7: Separate Products Requiring Cross Labeling

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/06/2009	04/30/2020

Labeler - Episciences, Inc. (144733040)

Registrant - Episciences, Inc. (144733040)

Establishment
Name	Address	ID/FEI	Business Operations
Episciences, Inc.		144733040	manufacture(42673-004)