DailyMed - 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

Contains inactivated NDC Code(s)
NDC Code(s): 13537-511-01, 13537-511-02, 13537-512-01, 13537-512-02, view more
13537-513-01, 13537-513-02, 13537-514-01, 13537-514-02, 13537-515-01, 13537-515-02, 13537-516-01, 13537-516-02, 13537-517-01, 13537-517-02, 13537-518-01, 13537-518-02, 13537-519-01, 13537-519-02, 13537-520-01, 13537-520-02, 13537-521-01, 13537-521-02, 13537-522-01, 13537-522-02, 13537-523-01, 13537-523-02, 13537-524-01, 13537-524-02, 13537-525-01, 13537-525-02
Packager: Ventura Corporation LTD.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not 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 June 6, 2013

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

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

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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

P.R.: Dist by Ventura Corp, Ltd., San Juan, Puerto Rico 00926 Made in Colombia.
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MOKA

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROMANCE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE NATURAL

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE CLASIQUE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE INTENSE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - AMOUR

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CHOCOLAT

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ALMOND

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MALVE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRON GLACÉ

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - TULIP

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - LILY BEIGE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MANDARINE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL
PRINCIPAL DISPLAY PANEL - 4 g 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:13537-511
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-511-02	1 in 1 BOX
1	NDC:13537-511-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-512
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-512-02	1 in 1 BOX
1	NDC:13537-512-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-513
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-513-02	1 in 1 BOX
1	NDC:13537-513-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-514
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-514-02	1 in 1 BOX
1	NDC:13537-514-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-515
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-515-02	1 in 1 BOX
1	NDC:13537-515-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-516
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-516-02	1 in 1 BOX
1	NDC:13537-516-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-517
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-517-02	1 in 1 BOX
1	NDC:13537-517-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-518
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-518-02	1 in 1 BOX
1	NDC:13537-518-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-519
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-519-02	1 in 1 BOX
1	NDC:13537-519-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-520
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-520-02	1 in 1 BOX
1	NDC:13537-520-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-521
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-521-02	1 in 1 BOX
1	NDC:13537-521-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-522
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-522-02	1 in 1 BOX
1	NDC:13537-522-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-523
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-523-02	1 in 1 BOX
1	NDC:13537-523-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-524
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-524-02	1 in 1 BOX
1	NDC:13537-524-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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:13537-525
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	0.016 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)
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

#	Item Code	Package Description
Packaging
1	NDC:13537-525-02	1 in 1 BOX
1	NDC:13537-525-01	4 g in 1 TUBE

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

Labeler - Ventura Corporation LTD. (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-511, 13537-512, 13537-513, 13537-514, 13537-515, 13537-516, 13537-517, 13537-518, 13537-519, 13537-520, 13537-521, 13537-522, 13537-523, 13537-524, 13537-525)

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	NDC
1	13537-511-01
2	13537-511-02 (inactivated)
3	13537-512-01
4	13537-512-02 (inactivated)
5	13537-513-01
6	13537-513-02 (inactivated)
7	13537-514-01
8	13537-514-02 (inactivated)
9	13537-515-01
10	13537-515-02 (inactivated)
11	13537-516-01
12	13537-516-02 (inactivated)
13	13537-517-01
14	13537-517-02 (inactivated)
15	13537-518-01
16	13537-518-02 (inactivated)
17	13537-519-01
18	13537-519-02 (inactivated)
19	13537-520-01
20	13537-520-02 (inactivated)
21	13537-521-01
22	13537-521-02 (inactivated)
23	13537-522-01
24	13537-522-02 (inactivated)
25	13537-523-01
26	13537-523-02 (inactivated)
27	13537-524-01
28	13537-524-02 (inactivated)
29	13537-525-01
30	13537-525-02 (inactivated)

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