LBEL HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 - MOKA- octinoxate and oxybenzone lipstick LBEL HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROMANCE- octinoxate and oxybenzone lipstick LBEL HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROSE NATURAL- octinoxate and oxybenzone lipstick LBEL HYDRATESS LONG-LASTING INTENSE MOIST .......NUDE- octinoxate and oxybenzone lipstick LBEL HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 - LILY BEIGE- octinoxate and oxybenzone lipstick LBEL HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 - MANDARINE- octinoxate and oxybenzone lipstick LBEL HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 - VIN- octinoxate and oxybenzone lipstick

LBEL HYDRATESS by

Drug Labeling and Warnings

LBEL 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, MICA, TRIDECYL STEARATE, POLYETHYLENE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), OZOKERITE, POLYMETHYL METHACRYLATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE, PHENOXYETHANOL, COCOS NUCIFERA OIL (COCOS NUCIFERA (COCONUT) OIL), TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF EXTRACT, SILICA, PARFUM (FRAGRANCE), BUTYROSPERMUM PARKII  BUTTER (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:
RED 7 LAKE, TITANIUM DIOXIDE, IRON OXIDES, MICA, YELLOW 5 LAKE, RED 30 LAKE, TALC, BLUE 1 LAKE, RED 27 LAKE, CARMINE.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 4g Tube Box - MOKA

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROMANCE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROSE NATURAL

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROSE CLASIQUE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - ROUGE INTENSE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - AMOUR

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - CHOCOLAT

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - ALMOND

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - MALVE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - MARRON GLACÉ

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - TULIP

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - NUDE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - LILY BEIGE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - MANDARINE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 4g Tube Box - VIN

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - MOKA
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-095
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	BROWN (Pink brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-095-02	1 in 1 BOX
1	NDC: 14783-095-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROMANCE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-096
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	PINK (Dark magenta)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-096-02	1 in 1 BOX
1	NDC: 14783-096-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROSE NATURAL
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-097
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	PINK (Intense yellowish pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-097-02	1 in 1 BOX
1	NDC: 14783-097-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROSE CLASIQUE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-098
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	PINK (Intense bluish pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-098-02	1 in 1 BOX
1	NDC: 14783-098-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ROUGE INTENSE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-099
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	RED (Bluish red)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-099-02	1 in 1 BOX
1	NDC: 14783-099-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - AMOUR
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-100
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	BROWN (Red brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-100-02	1 in 1 BOX
1	NDC: 14783-100-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - CHOCOLAT
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-101
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	BROWN (Yellowish brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-101-02	1 in 1 BOX
1	NDC: 14783-101-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - ALMOND
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-102
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	BROWN (Reddish brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-102-02	1 in 1 BOX
1	NDC: 14783-102-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - MALVE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-103
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	RED (Yellowish red)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-103-02	1 in 1 BOX
1	NDC: 14783-103-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - MARRON GLACE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-104
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	BROWN (Purplish brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-104-02	1 in 1 BOX
1	NDC: 14783-104-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - TULIP
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-105
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	PINK (Yellowish pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-105-02	1 in 1 BOX
1	NDC: 14783-105-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - NUDE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-106
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	PINK (Light Yellowish pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-106-02	1 in 1 BOX
1	NDC: 14783-106-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - LILY BEIGE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-107
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	BROWN (Light pinkish brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-107-02	1 in 1 BOX
1	NDC: 14783-107-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - MANDARINE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-108
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-108-02	1 in 1 BOX
1	NDC: 14783-108-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

LBEL HYDRATESS   LONG-LASTING INTENSE MOISTURIZING SPF 20 - VIN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-109
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)
MICA (UNII: V8A1AW0880)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	PURPLE (Brownish purple)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-109-02	1 in 1 BOX
1	NDC: 14783-109-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/27/2013

Labeler - Ventura International LTD. (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-095, 14783-096, 14783-097, 14783-098, 14783-099, 14783-100, 14783-101, 14783-102, 14783-103, 14783-104, 14783-105, 14783-106, 14783-107, 14783-108, 14783-109)