Drug Labeling and Warnings

Drug Details [pdf]

EPIONCE ACTIVE SHIELD SPF 30- homosalate, zinc oxide, octisalate lotion 
Episciences, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredients

Homosalate 10.0%

Zinc Oxide 9.2%

Octisalate 5.0%

Purpose

Sunscreen

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

helps prevent sunburn

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or
sweating
reapply at least every 2 hours
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 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

Ask a doctor

children under 6 months

Inactive Ingredients

Water, Alkyl (C12-15) Benzoate, Butylene Glycol,
Glycerin, Steareth-21, Phenyl Trimethicone, Meadowfoam
Seed Oil, Cetostearyl Alcohol, Safflower Oil,
Ammonium Acryloyldimethyltaurate/VP Copolymer,
Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol,
Linseed Oil, Malic Acid, Phenoxyethanol, Date, Polyhydroxystearic
Acid (2300 MW), Steareth-2, Triethoxycaprylylsilane,
Pyrithione Zinc.

Other Information

protect this product from excessive heat and direct sun

Questions?

Call toll free 1-800-374-6623

Drug Facts

EPIONCE ACTIVE SHIELD  SPF 30
homosalate, zinc oxide, octisalate lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42673-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.1 mL  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.92 mL  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 mL  in 1 mL

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)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
LINSEED OIL (UNII: 84XB4DV00W)
MALIC ACID (UNII: 817L1N4CKP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DATE (UNII: H3O7QI5HY7)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
PYRITHIONE ZINC (UNII: R953O2RHZ5)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42673-002-02	1 in 1 BOX
1	NDC: 42673-002-01	75 mL in 1 TUBE
2	NDC: 42673-002-04	453 mL in 1 JAR
3	NDC: 42673-002-03	6 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/24/2005	03/24/2005

Labeler - Episciences, Inc. (144733040)

Registrant - Episciences, Inc. (144733040)

Establishment
Name	Address	ID/FEI	Business Operations
Episciences, Inc.		144733040	manufacture(42673-002)

Revised: 6/2019

Document Id: 85774c12-4f18-4bd5-e053-2991aa0a9aa6

34391-3

Set id: 608d1bb0-10e2-476c-bf60-cc4980768545

Version: 2

Effective Time: 20190625