EXUVIANCE COVERBLEND CONCEALING TREATMENT MAKEUP SPF 30 BISQUE- titanium dioxide and zinc oxide cream

Exuviance CoverBlend Concealing Treatment Makeup by

Drug Labeling and Warnings

Exuviance CoverBlend Concealing Treatment Makeup by is a Otc medication manufactured, distributed, or labeled by NeoStrata Company Inc., Cosmetic Essence, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide 15.97%
Zinc Oxide 2.09%

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

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

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

Directions

• Using fingertip or sponge, apply makeup evenly to face, blending edges, 15 minutes before sun exposure. To conceal serious flaws, apply in a dab/pat motion and build until desired coverage is achieved.
• 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

Other information

• Store at 15°C - 30°C (59°F - 86°F)
• Protect this product from excessive heat and direct sun

Inactive ingredients

Aqua (Water), Cyclopentasiloxane, Butylene Glycol, Gluconolactone, Hydrogenated Castor Oil, Isodocecane, Acrylates/Dimethicone Copolymer, Isotridecyl Isononanoate, Sodium Chloride, Polymethyl Methacrylate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, PEG/PPG-18/18 Dimethicone, Behenoyl Stearic Acid, Tocopheryl (Vitamin E) Acetate, Arginine, Methicone, Stearic Acid, Triethanolamine, Triethoxycaprylylsilane, Aluminum Hydroxide, PEG-150/Decyl Alcohol/SMDI Copolymer, Propylene Glycol, Chlorphenesin, Methylparaben, CI 77492 (Iron Oxide Yellow), CI 77491 (Iron Oxide Red), CI 77499 (Iron Oxide Black)

Questions or comments?

Call toll free 1-800-225-9411 (9am – 5pm ET)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

DERMATOLOGIST
DEVELOPED

Exuviance®

CoverBlend

Concealing Treatment
MakeUp

with Sunscreen Broad Spectrum SPF 30

Full all-day flawless color

Powerful antiaging benefits

Net Wt 30 g / 1.0 oz

INGREDIENTS AND APPEARANCE

EXUVIANCE COVERBLEND CONCEALING TREATMENT MAKEUP   SPF 30 BISQUE
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-3501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	159.7 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.9 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISODODECANE (UNII: A8289P68Y2)
ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
7-BEHENOYLSTEARIC ACID (UNII: P2T8BLD83C)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ARGININE (UNII: 94ZLA3W45F)
METHICONE (20 CST) (UNII: 6777U11MKT)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PEG-150/DECYL ALCOHOL/SMDI COPOLYMER (1350 MPA.S AT 3%) (UNII: VP5LS3541F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58414-3501-1	1 in 1 CARTON	08/01/2013	09/30/2020
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2013	09/30/2020

Labeler - NeoStrata Company Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC.		825646862	MANUFACTURE(58414-3501)