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

Concealer Broad Spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Concealer Broad Spectrum Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Epione Medical Corporation, VEGE-KURL, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Titanium Dioxide 5.00%

Zinc Oxide 10.00%

PURPOSE

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

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

INDICATIONS & USAGE

Stop use/ contact a doctor if rash occurs

WARNINGS

Warnings:

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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).

PRINCIPAL DISPLAY PANEL

Epione

Concealer Broad Spectrum SPF 30+

1.0 FL OZ (30mL)

INGREDIENTS AND APPEARANCE

CONCEALER BROAD SPECTRUM SUNSCREEN SPF 30 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70698-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70698-004-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/05/2018

Labeler - Epione Medical Corporation (088809509)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC		021072509	manufacture(70698-004)