Epionce Active Shield Lotion SPF30+

Drug Labeling and Warnings

Drug Details [pdf]

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.

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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:

Back side of insert:

EPIONCE ACTIVE SHIELD 
homosalate, zinc oxide, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42673-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.1 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0912 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42673-003-02	1 in 1 BOX	03/24/2005	05/31/2019
1	NDC: 42673-003-01	75 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 42673-003-03	453 g in 1 JAR; Type 0: Not a Combination Product	03/24/2005	07/31/2017
3	NDC: 42673-003-04	230 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/25/2013	08/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2005	05/31/2019

Labeler - Episciences, Inc. (144733040)

Registrant - Episciences, Inc. (144733040)

Establishment
Name	Address	ID/FEI	Business Operations
Episciences, Inc.		144733040	manufacture(42673-003)

Revised: 12/2017

Document Id: 5f9a42cb-c820-6e9a-e053-2991aa0ad91d

34390-5

Set id: 3909b7b2-0553-119c-e054-00144ff8d46c

Version: 5

Effective Time: 20171205