EPIONCE ULTRA SHIELD- homosalate, octisalate, zinc oxide 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.

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Epionce Ultra Shield SPF 50

Active ingredients

Homosalate 9.95%

Octisalate 5.0%

Zinc Oxide 10.1%

Purpose

Sunscreen

Uses

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

Other information

• protect this product from excessive heat and direct sun

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 (4500 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.

Questions?

Call toll free 1-866-374-6623

Prinicipal Display Panel

USL 2.5oz PDP

EPIONCE ULTRA SHIELD 
homosalate, octisalate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42673-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.101 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.1 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
LINSEED OIL (UNII: 84XB4DV00W)  
MALIC ACID (UNII: 817L1N4CKP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DATE (UNII: H3O7QI5HY7)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARETH-2 (UNII: V56DFE46J5)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
STEARETH-21 (UNII: 53J3F32P58)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42673-011-021 in 1 BOX04/06/200908/31/2024
1NDC:42673-011-0175 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:42673-011-051 in 1 BOX04/06/200908/31/2024
2NDC:42673-011-0430 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:42673-011-006 g in 1 TUBE; Type 0: Not a Combination Product04/06/200908/31/2024
4NDC:42673-011-03454 g in 1 JAR; Type 0: Not a Combination Product04/06/200908/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/06/200908/31/2024
Labeler - Episciences, Inc. (144733040)
Establishment
NameAddressID/FEIBusiness Operations
Episciences, Inc.144733040manufacture(42673-011)

Revised: 9/2022
Document Id: e921a5c1-d0f7-0004-e053-2995a90af6e5
Set id: c4d030c4-6b2f-004d-e053-2995a90a441e
Version: 4
Effective Time: 20220920
 
Episciences, Inc.