FDA.reportPublic FDA data

Epionce Skin Barrier Repair Kit

Manufacturer
Episciences, Inc.
Effective date
2018-12-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-02 00:44:12

Label at a glance#

ProductEpionce Skin Barrier Repair Kit
Active ingredientOCTISALATE, HOMOSALATE, ZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn

Dosage and administration

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 protecti...

Storage and handling

protect this product from excessive heat and direct sunlight

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 9.95%

Octisalate 5.0%

Zinc Oxide 10.1%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • damaged or broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sunlight

Questions?

OTHER SAFETY INFORMATION

Call toll free 1-866-374-6623

Skin Barrier Repair Kit Package Insert

SPL PATIENT PACKAGE INSERT SECTION

Package Insert Side A:

Box Insert Side ABox Insert Side A

Package Insert Side B:

Box Insert Side BBox Insert Side B

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front of the Retail BoxFront of the Retail Box

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42673-00442673-004-01, 42673-004-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DATEH3O7QI5HY7IACT
GLYCERINPDC6A3C0OXIACT
OCTISALATE4X49Y0596WACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HOMOSALATEV06SV4M95SACTIB
ZINC OXIDESOI2LOH54ZACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
LINSEED OIL84XB4DV00WIACT
MALIC ACID817L1N4CKPIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYSORBATE 806OZP39ZG8HIACT
SAFFLOWER OIL65UEH262ISIACT
STEARETH-2V56DFE46J5IACT
STEARETH-2153J3F32P58IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7c5ce3bc-8d35-de44-e053-2991aa0a0abf39454232-f209-2fef-e054-00144ff8d46c2018-12-06WarningsExact identifier
spl id: 7c5ce3bc-8d35-de44-e053-2991aa0a0abf
spl set id: 39454232-f209-2fef-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.