ULTRA LE TEINT VELVET BLURRING SMOOTH-EFFECT FOUNDATION VELVET MATTE FINISH BROAD SPECTRUM SPF 15 SUNSCREEN BD91- octinoxate and titanium dioxide liquid ULTRA LE TEINT VELVET BLURRING SMOOTH-EFFECT FOUNDATION VELVET MATTE FINISH BROAD SPECTRUM SPF 15 SUNSCREEN BD121- octinoxate and titanium dioxide liquid

Ultra Le Teint Velvet by

Drug Labeling and Warnings

Ultra Le Teint Velvet 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 4.2%	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

water isododecane dimethicone hydrogenated polyisobutene dicaprylyl carbonate alcohol methyl methacrylate crosspolymer cellulose PEG-9 polydimethylsiloxyethyl dimethicone isodecyl neopentanoate propylene glycol dicaprylate stearalkonium hectorite aluminum hydroxide sodium chloride stearic acid dimethicone/bis-isobutyl PPG-20 crosspolymer phenoxyethanol propylene carbonate fragrance talc sodium lauroyl glutamate biosaccharide gum-1 lysine trimethylsiloxysilicate/dimethiconol crosspolymer magnesium chloride BHT tocopherol hydrogenated lecithin triethoxycaprylylsilane hydrated silica (may contain) ultramarines iron oxides titanium dioxide mica

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Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - BD91

ULTRA
LE TEINT VELVET

BLURRING SMOOTH-EFFECT
FOUNDATION
VELVET MATTE FINISH

BROAD SPECTRUM SPF 15
SUNSCREEN

BD91

CHANEL

30 ml
1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - BD121

ULTRA
LE TEINT VELVET

BLURRING SMOOTH-EFFECT
FOUNDATION
VELVET MATTE FINISH

BROAD SPECTRUM SPF 15
SUNSCREEN

BD121

CHANEL

30 ml
1 FL.OZ.

INGREDIENTS AND APPEARANCE

ULTRA LE TEINT VELVET   BLURRING SMOOTH-EFFECT FOUNDATION VELVET MATTE FINISH BROAD SPECTRUM SPF 15 SUNSCREEN BD91
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	42 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
hydrogenated polybutene (1300 MW) (UNII: 7D1YQ9Y5EZ)
dicaprylyl carbonate (UNII: 609A3V1SUA)
alcohol (UNII: 3K9958V90M)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)
powdered cellulose (UNII: SMD1X3XO9M)
PEG-9 polydimethylsiloxyethyl dimethicone (UNII: TYP81E471F)
isodecyl neopentanoate (UNII: W60VYE24XC)
propylene glycol dicaprylate (UNII: 581437HWX2)
stearalkonium hectorite (UNII: OLX698AH5P)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium chloride (UNII: 451W47IQ8X)
stearic acid (UNII: 4ELV7Z65AP)
dimethicone/bis-isobutyl PPG-20 crosspolymer (UNII: O4I3UFO6ZF)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
talc (UNII: 7SEV7J4R1U)
sodium lauroyl glutamate (UNII: NCX1UU2D33)
biosaccharide gum-1 (UNII: BB4PU4V09H)
lysine (UNII: K3Z4F929H6)
magnesium chloride (UNII: 02F3473H9O)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
tocopherol (UNII: R0ZB2556P8)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
triethoxycaprylylsilane (UNII: LDC331P08E)
hydrated silica (UNII: Y6O7T4G8P9)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2128-1	1 in 1 CARTON	08/15/2019
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68745-2128-2	1 in 1 CARTON	08/15/2019
2		20 mL in 1 BOTTLE; 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	08/15/2019

ULTRA LE TEINT VELVET   BLURRING SMOOTH-EFFECT FOUNDATION VELVET MATTE FINISH BROAD SPECTRUM SPF 15 SUNSCREEN BD121
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68745-2129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium dioxide	42 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
hydrogenated polybutene (1300 MW) (UNII: 7D1YQ9Y5EZ)
dicaprylyl carbonate (UNII: 609A3V1SUA)
alcohol (UNII: 3K9958V90M)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)
powdered cellulose (UNII: SMD1X3XO9M)
PEG-9 polydimethylsiloxyethyl dimethicone (UNII: TYP81E471F)
isodecyl neopentanoate (UNII: W60VYE24XC)
propylene glycol dicaprylate (UNII: 581437HWX2)
stearalkonium hectorite (UNII: OLX698AH5P)
aluminum hydroxide (UNII: 5QB0T2IUN0)
sodium chloride (UNII: 451W47IQ8X)
stearic acid (UNII: 4ELV7Z65AP)
dimethicone/bis-isobutyl PPG-20 crosspolymer (UNII: O4I3UFO6ZF)
phenoxyethanol (UNII: HIE492ZZ3T)
propylene carbonate (UNII: 8D08K3S51E)
talc (UNII: 7SEV7J4R1U)
sodium lauroyl glutamate (UNII: NCX1UU2D33)
biosaccharide gum-1 (UNII: BB4PU4V09H)
lysine (UNII: K3Z4F929H6)
magnesium chloride (UNII: 02F3473H9O)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
tocopherol (UNII: R0ZB2556P8)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
triethoxycaprylylsilane (UNII: LDC331P08E)
hydrated silica (UNII: Y6O7T4G8P9)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68745-2129-1	1 in 1 CARTON	08/15/2019
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68745-2129-2	1 in 1 CARTON	08/15/2019
2		20 mL in 1 BOTTLE; 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	08/15/2019

Labeler - CHANEL PARFUMS BEAUTE (275137669)

Establishment
Name	Address	ID/FEI	Business Operations
CHANEL PARFUMS BEAUTE		277032509	MANUFACTURE(68745-2128, 68745-2129) , LABEL(68745-2128, 68745-2129)