EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - PINK- octinoxate and oxybenzone lipstick EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK- octinoxate and oxybenzone lipstick EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE NATURAL) - PINK- octinoxate and oxybenzone lipstick EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHERRY BLOSSOM) - RED- octinoxate and oxybenzone lipstick EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN AMANT) - PURPLE- octinoxate and oxybenzone lipstick EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PINK- octinoxate and oxybenzone lipstick

EFFET PARFAIT HYDRATESS by

Drug Labeling and Warnings

EFFET PARFAIT HYDRATESS by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OCTINOXATE: 7.1 %

OXYBENZONE: 1.6 %

Purpose

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, not skin cancer or early skin aging.
• For external use only.

• Do not use on damage or broken skin.

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

• Stop use and ask a doctor if rash occurs.

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Children under 6 months of age: Ask a doctor.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Apply lipstick following the curves of natural lip line. For added definition, use with a lip pencil.

Other information

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

Inactive ingredients

CAPRYLIC/CAPRIC TRIGLYCERIDE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, COPERNICIA CERIFERA (CARNAUBA) WAX, MICA, 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. 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.

SPL UNCLASSIFIED SECTION

US:
Dist. by Ventura Int Ltd. DBA
Belcorp USA, San Francisco,
CA 94111.

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

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

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 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 - (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 - (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 - (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 - (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 - (MALVE) - 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 - (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 - (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 - (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 - (LILY BEIGE) - 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 - (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 - (VIN) - 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 - (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 - (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 - (RICHE PINK) - 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

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) - 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 - (SOLEIL) - 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 - (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 - (CHERRY BLOSSOM) - 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 - (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 - (NUDE INTIME) - PINK

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

INGREDIENTS AND APPEARANCE

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-891
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-891-02	1 in 1 BOX
1	NDC: 14783-891-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-892
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-892-04	1 in 1 BOX
1	NDC: 14783-892-03	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE NATURAL) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-893
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-893-06	1 in 1 BOX
1	NDC: 14783-893-05	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE CLASIQUE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-894
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-894-08	1 in 1 BOX
1	NDC: 14783-894-07	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROUGE INTENSE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-895
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-895-10	1 in 1 BOX
1	NDC: 14783-895-09	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (AMOUR) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-896
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-896-12	1 in 1 BOX
1	NDC: 14783-896-11	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHOCOLAT) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-897
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-897-14	1 in 1 BOX
1	NDC: 14783-897-13	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (ALMOND) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-898
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-898-16	1 in 1 BOX
1	NDC: 14783-898-15	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (MALVE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-899
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-899-18	1 in 1 BOX
1	NDC: 14783-899-17	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (MARRON GLACE) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-900-20	1 in 1 BOX
1	NDC: 14783-900-19	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-940
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-940-22	1 in 1 BOX
1	NDC: 14783-940-21	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (TULIP) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-902
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-902-24	1 in 1 BOX
1	NDC: 14783-902-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (LILY BEIGE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-903
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-903-26	1 in 1 BOX
1	NDC: 14783-903-25	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (MANDARINE) - ORANGE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-904-28	1 in 1 BOX
1	NDC: 14783-904-27	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-905
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-905-30	1 in 1 BOX
1	NDC: 14783-905-29	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (TEA ROSE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-906
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-906-32	1 in 1 BOX
1	NDC: 14783-906-31	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (FRENESIE) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-907
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-907-34	1 in 1 BOX
1	NDC: 14783-907-33	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (RICHE PINK) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-908
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-908-36	1 in 1 BOX
1	NDC: 14783-908-35	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (RED EXTASSY) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-909
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-909-38	1 in 1 BOX
1	NDC: 14783-909-37	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (FUCSIA) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-910
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-910-40	1 in 1 BOX
1	NDC: 14783-910-39	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (SOLEIL) - ORANGE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-911
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-911-42	1 in 1 BOX
1	NDC: 14783-911-41	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (TERRE) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-912
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-912-44	1 in 1 BOX
1	NDC: 14783-912-43	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHERRY BLOSSOM) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-913
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-913-46	1 in 1 BOX
1	NDC: 14783-913-45	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN AMANT) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-914
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-914-48	1 in 1 BOX
1	NDC: 14783-914-47	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

EFFET PARFAIT HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-915
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.071 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
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 3 (UNII: 4370DF050B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-915-50	1 in 1 BOX
1	NDC: 14783-915-49	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2014

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-891, 14783-892, 14783-893, 14783-894, 14783-895, 14783-896, 14783-897, 14783-898, 14783-899, 14783-900, 14783-940, 14783-902, 14783-903, 14783-904, 14783-905, 14783-906, 14783-907, 14783-908, 14783-909, 14783-910, 14783-911, 14783-912, 14783-913, 14783-914, 14783-915)