Epionce Ultra Shield SPF 50

Epionce Ultra Shield by

Drug Labeling and Warnings

Epionce Ultra Shield by is a Otc medication manufactured, distributed, or labeled by Episciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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 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

EPIONCE ULTRA SHIELD 
homosalate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42673-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.101 g  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.1 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42673-011-02	1 in 1 BOX	04/06/2009	08/31/2024
1	NDC: 42673-011-01	75 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 42673-011-05	1 in 1 BOX	04/06/2009	08/31/2024
2	NDC: 42673-011-04	30 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 42673-011-00	6 g in 1 TUBE; Type 0: Not a Combination Product	04/06/2009	08/31/2024
4	NDC: 42673-011-03	454 g in 1 JAR; Type 0: Not a Combination Product	04/06/2009	08/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/06/2009	08/31/2024

Labeler - Episciences, Inc. (144733040)

Establishment
Name	Address	ID/FEI	Business Operations
Episciences, Inc.		144733040	manufacture(42673-011)

Revised: 9/2022

Document Id: e921a5c1-d0f7-0004-e053-2995a90af6e5

34390-5

Set id: c4d030c4-6b2f-004d-e053-2995a90a441e

Version: 4

Effective Time: 20220920