EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 BISQUE- titanium dioxide liquid EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 BLUSH BEIGE- titanium dioxide liquid EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 TRUE BEIGE- titanium dioxide liquid EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 NEUTRAL BEIGE- titanium dioxide liquid EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 WARM BEIGE- titanium dioxide liquid EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 HONEY SAND- titanium dioxide liquid EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 DESERT SAND- titanium dioxide liquid EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 CLASSIC BEIGE- titanium dioxide liquid EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 GOLDEN BEIGE- titanium dioxide liquid EXUVIANCE COVERBLEND SKIN CARING FOUNDATION SPF 20 TOASTED ALMOND- titanium dioxide liquid

Exuviance CoverBlend Skin Caring Foundation by

Drug Labeling and Warnings

Exuviance CoverBlend Skin Caring Foundation by is a Otc medication manufactured, distributed, or labeled by NeoStrata Company, Inc., Kolmar Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide 7.8%

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

• Shake. Blend on evenly with fingertips 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating
• Reapply sunscreen 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), Cyclohexasiloxane, Cyclopentasiloxane, Isostearyl Neopentanoate, Talc, Gluconolactone, Isododecane, Butylene Glycol, Isohexadecane, Nylon-12, Polymethyl Methacrylate, Glycerin, Silica, Polyethylene, Sorbitan Sesquioleate, Disteardimonium Hectorite, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Lactobionic Acid, Tocopheryl Linoleate/Oleate, Lecithin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Stearic Acid, Aluminum Hydroxide, Propylene Carbonate, PEG/PPG-18/18 Dimethicone, Perfluorooctyl Triethoxysilane, Ammonium C6-16 Perfluoroalkylethyl Phosphate, Cetyl PEG/PPG-10/1 Dimethicone, Ammonium Hydroxide, Magnesium Stearate, Polymethylsilsesquioxane, Phenoxyethanol, Chlorphenesin. MAY CONTAIN: 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 mL Bottle Carton - Bisque

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Blush Beige

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - True Beige

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral Beige

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Warm Beige

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Honey Sand

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Desert Sand

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Classic Beige

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden Beige

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Toasted Almond

DERMATOLOGIST DEVELOPED

Exuviance®

CB

CoverBlend

Skin Caring Foundation

with Sunscreen Broad Spectrum
SPF 20

Light to medium, all-day coverage
+
Powerful antiaging benefits

30 mL / 1.0 fl oz

INGREDIENTS AND APPEARANCE

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 BISQUE
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0001-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 BLUSH BEIGE
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0002-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 TRUE BEIGE
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0003-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 NEUTRAL BEIGE
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0004-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 WARM BEIGE
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0005-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 HONEY SAND
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0006-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 DESERT SAND
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0007-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 CLASSIC BEIGE
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0008-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 GOLDEN BEIGE
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0009-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

EXUVIANCE COVERBLEND SKIN CARING FOUNDATION   SPF 20 TOASTED ALMOND
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58414-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
TALC (UNII: 7SEV7J4R1U)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
NYLON-12 (UNII: 446U8J075B)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBIONIC ACID (UNII: 65R938S4DV)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
AMMONIA (UNII: 5138Q19F1X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
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: 58414-0010-1	1 in 1 CARTON	07/01/2015	08/12/2022
1		30 mL in 1 BOTTLE, PUMP; 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	07/01/2015	08/12/2022

Labeler - NeoStrata Company, Inc. (605754829)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Laboratories		001535103	MANUFACTURE(58414-0001, 58414-0002, 58414-0003, 58414-0004, 58414-0005, 58414-0006, 58414-0007, 58414-0008, 58414-0009, 58414-0010)