CONCEALER BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide, zinc oxide cream 
Epione Medical Corporation

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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Concealer Broad Spectrum SPF 30

Active Ingredients:

Titanium Dioxide 5.00%

Zinc Oxide 10.00%

Uses:

Helps prevent sunburn
If used as direct with other sun protection measures (see  Directions), decreases the risk of skin cancer and early aging caused by the sun.

Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away

Stop use/ contact a doctor if rash occurs

Warnings:

For external use only
Do not use on damaged or broken skin
Avoid contact with eyes. Rinse with water to remove

Directions:

Apply evenly 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children Under 6 months: Ask a doctor.

Sun Protection Measures:

Spending time in the sun increases the 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 10a.m.-2p.m.
Wear long-sleeved shirt, pants, hats, and sunglasses
Reapply at least every 2 hours

Water, Coconut Alkanes, Octyldodecyl Neopentanoate, Butylene Glycol, C12-15 Alkyl Benzoate, Polysorbate 60, Cyclopentasiloxane, Dimethicone, Cetearyl Alcohol, Glycerine, Polysorbate 60, Polyacrylamide, Polyhydroxystearic Acid, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, C13-14 Isoparaffin, Coco-Caprylate/Caprate, Stearic Acid, Acrylates/C10-30 Alklyl Acrylates Crosspolymer, Ethylhexylglycerin, Alumina, Xanthan Gum, Laureth-7, Triethanolamine, Iron Oxides( CI 77499, CI 77491, CI77492).

Epione

Concealer Broad Spectrum SPF 30+

1.0 FL OZ (30mL)

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CONCEALER BROAD SPECTRUM SUNSCREEN SPF 30 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70698-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LAURETH-7 (UNII: Z95S6G8201)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70698-004-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/05/2018
Labeler - Epione Medical Corporation (088809509)
Establishment
NameAddressID/FEIBusiness Operations
VEGE-KURL, INC021072509manufacture(70698-004)

Revised: 7/2018
Document Id: 701f42dc-6936-5cea-e053-2a91aa0ac8eb
Set id: 701f42dc-6935-5cea-e053-2a91aa0ac8eb
Version: 1
Effective Time: 20180703
 
Epione Medical Corporation