EPIONCE ACTIVE SHIELD- homosalate, zinc oxide, octisalate lotion 
Episciences, Inc.

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.

----------

Epionce Active Shield Lotion SPF30+

Active ingredients

Homosalate 10.0%

Zinc Oxide 9.2%

Octisalate 5.0%

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 Point Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 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 Specrum 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, Cetostearyl Alcohol, Date, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Linseed Oil, Malic Acid, Meadowfoam Seed Oil, Phenoxyethanol, Phenyl Trimethicone, Polyhydroxystearic Acid (2300 MW), Pyrithione Zinc, Safflower Oil, Steareth-2, Steareth-21, Triethoxycaprylylsilane, Water.

Other information

  • protect this product from excessive heat and direct sun

Questions?

Call toll free 1-866-374-6623

Active Shield Lotion SPF 30+ Package Insert

Front side of insert:

Sunscreen Insert Side A

Back side of insert:

Sunscreen Insert Side B

Active Shield Lotion SPF 30+

EPIONCE ACTIVE SHIELD 
homosalate, zinc oxide, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42673-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.1 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0912 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
STEARETH-2 (UNII: V56DFE46J5)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PYRITHIONE ZINC (UNII: R953O2RHZ5)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
DATE (UNII: H3O7QI5HY7)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LINSEED OIL (UNII: 84XB4DV00W)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
MALIC ACID (UNII: 817L1N4CKP)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARETH-21 (UNII: 53J3F32P58)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42673-003-021 in 1 BOX03/24/200505/31/2019
1NDC:42673-003-0175 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:42673-003-03453 g in 1 JAR; Type 0: Not a Combination Product03/24/200507/31/2017
3NDC:42673-003-04230 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/201308/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/24/200505/31/2019
Labeler - Episciences, Inc. (144733040)
Registrant - Episciences, Inc. (144733040)
Establishment
NameAddressID/FEIBusiness Operations
Episciences, Inc.144733040manufacture(42673-003)

Revised: 12/2017
Document Id: 5f9a42cb-c820-6e9a-e053-2991aa0ad91d
Set id: 3909b7b2-0553-119c-e054-00144ff8d46c
Version: 5
Effective Time: 20171205
 
Episciences, Inc.