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 
CHANEL PARFUMS BEAUTE

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ultra Le Teint Velvet
Blurring Smooth-Effect Foundation Velvet Matte Finish Broad Spectrum SPF 15 Sunscreen

Drug Facts

Active ingredientsPurpose
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 • 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 - BD91

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.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton - BD121
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68745-2128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate50 mg  in 1 mL
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium dioxide42 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68745-2128-11 in 1 CARTON08/15/2019
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68745-2128-21 in 1 CARTON08/15/2019
220 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/15/2019
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68745-2129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate50 mg  in 1 mL
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium dioxide42 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68745-2129-11 in 1 CARTON08/15/2019
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68745-2129-21 in 1 CARTON08/15/2019
220 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/15/2019
Labeler - CHANEL PARFUMS BEAUTE (275137669)
Establishment
NameAddressID/FEIBusiness Operations
CHANEL PARFUMS BEAUTE277032509MANUFACTURE(68745-2128, 68745-2129) , LABEL(68745-2128, 68745-2129)

Revised: 10/2020
Document Id: e16e2cd3-2778-4bce-bda0-6d387e629bd3
Set id: 00e5f68d-37b5-4a63-a8e7-34c44b790459
Version: 2
Effective Time: 20201027
 
CHANEL PARFUMS BEAUTE