LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 12 BEIGE ROSE- octinoxate, titanium dioxide, and zinc oxide powder LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 22 BEIGE ROSE- octinoxate, titanium dioxide, and zinc oxide powder LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROA .......15 SUNCREEEN 60 BEIGE- octinoxate, titanium dioxide, and zinc oxide powder LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 70 BEIGE- octinoxate, titanium dioxide, and zinc oxide powder LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 91 CARAMEL- octinoxate, titanium dioxide, and zinc oxide powder

LE TEINT ULTRA TENUE by

Drug Labeling and Warnings

LE TEINT ULTRA TENUE by is a Otc medication manufactured, distributed, or labeled by CHANEL PARFUMS BEAUTE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 5%	Sunscreen
Titanium dioxide 4.8%	Sunscreen
Zinc oxide 9.5%	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 skin rash occurs.

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

Directions

• For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • 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 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
  • Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

boron nitride talc vinyl dimethicone/methicone silsesquioxane crosspolymer acrylates/ethylhexyl acrylate crosspolymer triethylhexanoin dimethicone barium sulfate polymethylsilsesquioxane polymethyl methacrylate HDI/trimethylol hexyllactone crosspolymer alumina silica magnesium carbonate stearic acid aluminum hydroxide ammonium silver zinc aluminum silicate triethoxycaprylylsilane potassium sorbate sodium dehydroacetate chlorphenesin isopropyl titanium triisostearate hydrolyzed align aluminum dimyristate fragrance methyl methacrylate crosspolymer sodium lauroyl aspartate tocopheryl acetate trifluoropropyldimethyl/trimethylsiloxysilicate zinc sulfate zinc chloride phenoxyethanol BHT sodium lauroyl glutamate lysine magnesium chloride (may contain) ultramarines iron oxides titanium dioxide mica

Questions or comments?

Call 1-800-550-0005 M – F 9am –9pm EST, S – S 10am – 6pm EST.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 12 BEIGE ROSÉ

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

12 BEIGE ROSÉ

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 22 BEIGE ROSÉ

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

22 BEIGE ROSÉ

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 32 BEIGE ROSÉ

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

32 BEIGE ROSÉ

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 42 BEIGE ROSÉ

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

42 BEIGE ROSÉ

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 10 BEIGE

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

10 BEIGE

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 20 BEIGE

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

20 BEIGE

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 21 BEIGE

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

21 BEIGE

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 30 BEIGE

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

30 BEIGE

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 40 BEIGE

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

40 BEIGE

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 50 BEIGE

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

50 BEIGE

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 60 BEIGE

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

60 BEIGE

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 70 BEIGE

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

70 BEIGE

CHANEL

NET 13 g
NET WT. 0.45 OZ.

PRINCIPAL DISPLAY PANEL - 13 g Case Carton - 91 CARAMEL

LE TEINT ULTRA TENUE

ULTRAWEAR FLAWLESS COMPACT FOUNDATION

BROAD SPECTRUM SPF 15 SUNCREEEN

91 CARAMEL

CHANEL

NET 13 g
NET WT. 0.45 OZ.

INGREDIENTS AND APPEARANCE

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 12 BEIGE ROSE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2067-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 22 BEIGE ROSE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2068-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 32 BEIGE ROSE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2069-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 42 BEIGE ROSE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2070-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 10 BEIGE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2071-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 20 BEIGE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2072-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 21 BEIGE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2073-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 30 BEIGE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2074-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 40 BEIGE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2075-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 50 BEIGE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2076-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 60 BEIGE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2077
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2077-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 70 BEIGE
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2078
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2078-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

LE TEINT ULTRA TENUE   ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 91 CARAMEL
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.65 g  in 13 g
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	0.624 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	1.235 g  in 13 g

Inactive Ingredients
Ingredient Name	Strength
BORON NITRIDE (UNII: 2U4T60A6YD)
TALC (UNII: 7SEV7J4R1U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM OXIDE (UNII: LMI26O6933)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
SODIUM LAUROYL ASPARTATE (UNII: 328G13N8ZR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
ZINC CHLORIDE (UNII: 86Q357L16B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
LYSINE (UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2079-1	1 in 1 CARTON	08/01/2016
1		13 g in 1 CASE; 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	08/01/2016

Labeler - CHANEL PARFUMS BEAUTE (275137669)

Establishment
Name	Address	ID/FEI	Business Operations
CHANEL PARFUMS BEAUTE		277032509	MANUFACTURE(68745-2067, 68745-2068, 68745-2069, 68745-2070, 68745-2071, 68745-2072, 68745-2073, 68745-2074, 68745-2075, 68745-2076, 68745-2077, 68745-2078, 68745-2079) , LABEL(68745-2067, 68745-2068, 68745-2069, 68745-2070, 68745-2071, 68745-2072, 68745-2073, 68745-2074, 68745-2075, 68745-2076, 68745-2077, 68745-2078, 68745-2079)