Epionce Active Shield Lotion

Generic Name: homosalate, zinc oxide, octisalate
Dosage Form: lotion

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.

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 LABEL Item Code (Source) NDC:42673-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 0.10 mL  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.92 mL  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 0.05 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER  
BUTYLENE GLYCOL  
ALKYL (C12-15) BENZOATE  
CAPRYLYL GLYCOL  
SAFFLOWER OIL  
CETOSTEARYL ALCOHOL  
ETHYLHEXYLGLYCERIN  
GLYCERIN  
HEXYLENE GLYCOL  
MEADOWFOAM SEED OIL  
LINSEED OIL  
MALIC ACID  
PHENOXYETHANOL  
PHENYL TRIMETHICONE  
DATE  
POLYHYDROXYSTEARIC ACID (2300 MW)  
STEARETH-2  
STEARETH-21  
TRIETHOXYCAPRYLYLSILANE  
WATER  
PYRITHIONE ZINC  
Product Characteristics
Color white Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:42673-002-02 1 TUBE 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
OTC monograph final part352 03/24/2005
Labeler - Episciences, Inc. (144733040)
Registrant - Episciences, Inc. (144733040)
Establishment
Name Address ID/FEI Operations
Episciences, Inc. 144733040 manufacture(42673-002)
Revised: 08/2012
 
Episciences, Inc.



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