LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - BROWN- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE NATURAL) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROJO CLASIQUE) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROUGE INTENSE) - RED- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (AMOUR) - RED- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHOCOLAT) - BROWN- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ALMOND) - BROWN- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MALVE) - BROWN- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MARRON GLACE) - BROWN- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TULIP) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (LILY BEIGE) - BEIGE- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MANDARINE) - ORANGE- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN) - PURPLE- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TEA ROSE) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FRENESIE) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RICHE PINK) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RED EXTASSY) - RED- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FUCSIA) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (SOLEIL) - BROWN- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TERRE) - BROWN- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHERRY BLOSSOM) - PINK- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN AMANT) - PURPLE- octinoxate and oxybenzone lipstick 
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PURPLE- octinoxate and oxybenzone lipstick 
Ventura Corporation LTD

----------

L'BEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing lipstick SPF 20

Drug Facts

Active IngredientsPurpose
OCTINOXATE 7.10 %Sunscreen
OXYBENZONE 1.60 %Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

  • Skin Cancer / Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, notskin cancer or early skin aging.
  • For external use only.

  • Do not useon damaged or broken skin.

  • When using this productkeep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor ifrash occurs.

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

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • 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

CAPRYLIC/CAPRIC TRIGLYCERIDE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, MICA, COPERNICIA CERIFERA (CARNAUBA) WAX, TRIDECYL STEARATE, POLYETHYLENE, OZOKERITE, POLYMETHYL METHACRYLATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE,PHENOXYETHANOL, COCOS NUCIFERA (COCONUT) OIL, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF EXTRACT, SILICA, FRAGRANCE, BUTYROSPERMUM PARKII (SHEA) BUTTER, ELAEIS GUINEENSIS (PALM) OIL, GOSSYPIUM HERBACEUM (COTTON) SEED OIL, BIDENS PILOSA EXTRACT, DIMETHICONE,CAPRYLYL GLYCOL, LINUM USITATISSIMUM (LINSEED) SEED OIL, CHLORPHENESIN, BHT, CERAMIDE 3, CRAMBE MARITIMA EXTRACT, TRIMETHYLSILOXYSILICATE, PROPYLPARABEN, TOCOPHEROL, BENZYL BENZOATE, AMYL CINNAMAL, HEXYL CINNAMAL, LINALOOL, EUGENOL.

MAY CONTAIN :

MICA, TITANIUM DIOXIDE, IRON OXIDES, YELLOW 5 LAKE, RED 27 LAKE, RED 7 LAKE, RED 30 LAKE, TALC, BLUE 1 LAKE, SYNTHETIC FLUORPHLOGOPITE, RED 40 LAKE, CARMINE.

Dist. by
Ventura Corp, Ltd., San Juan,
Puerto Rico 00926.

Purpose

Sunscree

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MOKA) - BROWN

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (MOKA) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROMANCE) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (ROMANCE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSE NATURAL) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (ROSE NATURAL) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO CLASIQUE) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (ROJO CLASIQUE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROUGE INTENSE) - RED

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (ROUGE INTENSE) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (AMOUR) - RED

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (AMOUR) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CHOCOLAT) - BROWN

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (CHOCOLAT) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ALMOND) - BROWN

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (ALMOND) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MALVE) - BROWN

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (MALVE) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLACE) - BROWN

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (MARRON GLACE) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (TULIP) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (TULIP) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (NUDE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (LILY BEIGE) - BEIGE

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (LILY BEIGE) - BEIGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MANDARINE) - ORANGE

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (MANDARINE) - ORANGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN) - PURPLE

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (VIN) - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (TEA ROSE) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (TEA ROSE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRENESIE) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (FRENESIE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (RICHE PINK) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (RICHE PINK) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (RED EXTASSY) - RED

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (RED EXTASSY) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (FUCSIA) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (SOLEIL) - BROWN

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (SOLEIL) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (TERRE) - BROWN

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (TERRE) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CHERRY BLOSSOM) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (CHERRY BLOSSOM) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VIN AMANT) - PURPLE

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (VIN AMANT) - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NUDE INTIME) - PURPLE

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Principal Display Panel - 4 g Tube Box - (NUDE INTIME) - PURPLE
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (MOKA) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-085-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-085-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ROMANCE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-086
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-086-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-086-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ROSE NATURAL) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-087
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-087-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-087-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ROJO CLASIQUE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-090
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-090-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-090-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ROUGE INTENSE) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-091
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-091-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-091-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (AMOUR) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-092
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-092-121 in 1 BOX11/04/201612/31/2021
1NDC:13537-092-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (CHOCOLAT) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-093
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-093-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-093-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (ALMOND) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-094
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-094-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-094-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (MALVE) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-095-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-095-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (MARRON GLACE) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-096
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-096-201 in 1 BOX11/04/201612/31/2021
1NDC:13537-096-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (TULIP) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-097
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-097-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-097-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (NUDE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-098-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-098-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (LILY BEIGE) - BEIGE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-099-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-099-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (MANDARINE) - ORANGE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-178
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-178-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-178-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (VIN) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-179
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-179-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-179-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (TEA ROSE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-357
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-357-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-357-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (FRENESIE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-358
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-358-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-358-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (RICHE PINK) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-375
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-375-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-375-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (RED EXTASSY) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-376
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-376-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-376-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (FUCSIA) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-377
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-377-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-377-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (SOLEIL) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-378-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-378-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (TERRE) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-380
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-380-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-380-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (CHERRY BLOSSOM) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-381
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-381-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-381-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (VIN AMANT) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-382
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-382-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-382-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
LBEL EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20  (NUDE INTIME) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-424
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MICA (UNII: V8A1AW0880)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CERESIN (UNII: Q1LS2UJO3A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCONUT OIL (UNII: Q9L0O73W7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SHEA BUTTER (UNII: K49155WL9Y)  
PALM OIL (UNII: 5QUO05548Z)  
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LINSEED OIL (UNII: 84XB4DV00W)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CERAMIDE NP (UNII: 4370DF050B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
EUGENOL (UNII: 3T8H1794QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-424-021 in 1 BOX11/04/201612/31/2021
1NDC:13537-424-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/04/201612/31/2021
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-085, 13537-086, 13537-087, 13537-090, 13537-091, 13537-092, 13537-093, 13537-094, 13537-095, 13537-096, 13537-097, 13537-098, 13537-099, 13537-178, 13537-179, 13537-357, 13537-358, 13537-375, 13537-376, 13537-377, 13537-378, 13537-380, 13537-381, 13537-382, 13537-424)

Revised: 2/2025
 
Ventura Corporation LTD