DailyMed - 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 .......FET 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

Contains inactivated NDC Code(s)
NDC Code(s): 14783-008-01, 14783-008-02, 14783-009-01, 14783-009-20, view more
14783-020-01, 14783-020-02, 14783-021-01, 14783-021-02, 14783-022-01, 14783-022-02, 14783-023-01, 14783-023-02, 14783-024-01, 14783-024-02, 14783-026-01, 14783-026-02, 14783-027-01, 14783-027-02, 14783-036-01, 14783-036-02, 14783-037-01, 14783-037-02, 14783-040-01, 14783-040-02, 14783-041-01, 14783-041-02, 14783-042-01, 14783-042-02, 14783-043-01, 14783-043-02, 14783-044-01, 14783-044-02, 14783-046-01, 14783-046-02, 14783-047-01, 14783-047-02, 14783-048-01, 14783-048-02, 14783-050-01, 14783-050-02, 14783-051-01, 14783-051-02, 14783-052-01, 14783-052-02, 14783-053-01, 14783-053-12, 14783-054-01, 14783-054-02, 14783-063-01, 14783-063-02
Packager: Ventura International LTD

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

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

Drug Label Information

Updated December 5, 2016

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active Ingredients Purpose

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, not skin cancer or early skin aging.
- For external use only.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if 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.
- 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.
SPL UNCLASSIFIED SECTION

Dist. by Ventura Int Ltd. DBA
Belcorp USA, San Francisco,
CA 94111.
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 - (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 - (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 - (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) - 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

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 - (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 - (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 - (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) - 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 - (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) - 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 - (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) - 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 - (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 - (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) - 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 - (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) - PURPLE

L'BEL

EFFET
PARFAIT
HYDRATESS

long-lasting
intense
moisturizing
lipstick SPF 20

Net Weight 0.14 oz (4g)

Active Ingredients	Purpose
OCTINOXATE 7.10 %	Sunscreen
OXYBENZONE 1.60 %	Sunscreen

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-047
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-047-02	1 in 1 BOX	11/04/2016
1	NDC:14783-047-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-048
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-048-02	1 in 1 BOX	11/04/2016
1	NDC:14783-048-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-050
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-050-02	1 in 1 BOX	11/04/2016
1	NDC:14783-050-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-051
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-051-02	1 in 1 BOX	11/04/2016
1	NDC:14783-051-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-052
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-052-02	1 in 1 BOX	11/04/2016
1	NDC:14783-052-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-053
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-053-12	1 in 1 BOX	11/04/2016
1	NDC:14783-053-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-054
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-054-02	1 in 1 BOX	11/04/2016
1	NDC:14783-054-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-063
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-063-02	1 in 1 BOX	11/04/2016
1	NDC:14783-063-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-008-02	1 in 1 BOX	11/04/2016
1	NDC:14783-008-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-009-20	1 in 1 BOX	11/04/2016
1	NDC:14783-009-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-020-02	1 in 1 BOX	11/04/2016
1	NDC:14783-020-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-021
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-021-02	1 in 1 BOX	11/04/2016
1	NDC:14783-021-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-022
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-022-02	1 in 1 BOX	11/04/2016
1	NDC:14783-022-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-023
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-023-02	1 in 1 BOX	11/04/2016
1	NDC:14783-023-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-024
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-024-02	1 in 1 BOX	11/04/2016
1	NDC:14783-024-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-026
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-026-02	1 in 1 BOX	11/04/2016
1	NDC:14783-026-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-027
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-027-02	1 in 1 BOX	11/04/2016
1	NDC:14783-027-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-036
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-036-02	1 in 1 BOX	11/04/2016
1	NDC:14783-036-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-037
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-037-02	1 in 1 BOX	11/04/2016
1	NDC:14783-037-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-040-02	1 in 1 BOX	11/04/2016
1	NDC:14783-040-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-041
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-041-02	1 in 1 BOX	11/04/2016
1	NDC:14783-041-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-042
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-042-02	1 in 1 BOX	11/04/2016
1	NDC:14783-042-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-043
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-043-02	1 in 1 BOX	11/04/2016
1	NDC:14783-043-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

LBEL 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:14783-044
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-044-02	1 in 1 BOX	11/04/2016
1	NDC:14783-044-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-046
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.071 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.16 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-046-02	1 in 1 BOX	11/04/2016
1	NDC:14783-046-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/04/2016

Labeler - Ventura International LTD (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-047, 14783-048, 14783-050, 14783-051, 14783-052, 14783-053, 14783-054, 14783-063, 14783-008, 14783-009, 14783-020, 14783-021, 14783-022, 14783-023, 14783-024, 14783-026, 14783-027, 14783-036, 14783-037, 14783-040, 14783-041, 14783-042, 14783-043, 14783-044, 14783-046)

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	NDC
1	14783-008-01
2	14783-008-02 (inactivated)
3	14783-009-01
4	14783-009-20 (inactivated)
5	14783-020-01
6	14783-020-02 (inactivated)
7	14783-021-01
8	14783-021-02 (inactivated)
9	14783-022-01
10	14783-022-02 (inactivated)
11	14783-023-01
12	14783-023-02 (inactivated)
13	14783-024-01
14	14783-024-02 (inactivated)
15	14783-026-01
16	14783-026-02 (inactivated)
17	14783-027-01
18	14783-027-02 (inactivated)
19	14783-036-01
20	14783-036-02 (inactivated)
21	14783-037-01
22	14783-037-02 (inactivated)
23	14783-040-01
24	14783-040-02 (inactivated)
25	14783-041-01
26	14783-041-02 (inactivated)
27	14783-042-01
28	14783-042-02 (inactivated)
29	14783-043-01
30	14783-043-02 (inactivated)
31	14783-044-01
32	14783-044-02 (inactivated)
33	14783-046-01
34	14783-046-02 (inactivated)
35	14783-047-01
36	14783-047-02 (inactivated)
37	14783-048-01
38	14783-048-02 (inactivated)
39	14783-050-01
40	14783-050-02 (inactivated)
41	14783-051-01
42	14783-051-02 (inactivated)
43	14783-052-01
44	14783-052-02 (inactivated)
45	14783-053-01
46	14783-053-12 (inactivated)
47	14783-054-01
48	14783-054-02 (inactivated)
49	14783-063-01
50	14783-063-02 (inactivated)

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.