LBEL HYDRATESS description, usages, side effects, indications, overdosage, supplying and lots more!

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LBEL HYDRATESS

Ventura Corporation Ltd.

L'BEL HYDRATESS long-lasting intense moisturizing SPF 20


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

OCTINOXATE: 7.1%; OXYBENZONE: 1.6%

Purpose

Sunscreen

LBEL HYDRATESS 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.

LBEL HYDRATESS 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.

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

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROMANCE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE NATURAL

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSE CLASIQUE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROUGE INTENSE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - AMOUR

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CHOCOLAT

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ALMOND

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MALVE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRON GLACÉ

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - TULIP

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - LILY BEIGE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MANDARINE

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VIN

HYDRATESS

long-lasting intense moisturizing lipstick SPF 20

4 g e (.14 oz.)

L'BEL

LBEL HYDRATESS

LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-511
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
BROWN (Pink brown)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-511-01 4 in 1 TUBE
2 NDC:13537-511-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-512
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
PINK (Dark magenta)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-512-01 4 in 1 TUBE
2 NDC:13537-512-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-513
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
PINK (Intense yellowish pink)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-513-01 4 in 1 TUBE
2 NDC:13537-513-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-514
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
PINK (Intense bluish pink)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-514-01 4 in 1 TUBE
2 NDC:13537-514-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-515
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
RED (Bluish red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-515-01 4 in 1 TUBE
2 NDC:13537-515-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-516
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
BROWN (Red brown)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-516-01 4 in 1 TUBE
2 NDC:13537-516-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-517
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
BROWN (Yellowish brown)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-517-01 4 in 1 TUBE
2 NDC:13537-517-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-518
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
BROWN (Reddish brown)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-518-01 4 in 1 TUBE
2 NDC:13537-518-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-519
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
RED (Yellowish red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-519-01 4 in 1 TUBE
2 NDC:13537-519-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-520
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
BROWN (Purplish brown)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-520-01 4 in 1 TUBE
2 NDC:13537-520-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-521
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
PINK (Yellowish pink)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-521-01 4 in 1 TUBE
2 NDC:13537-521-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-522
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
PINK (Light Yellowish pink)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-522-01 4 in 1 TUBE
2 NDC:13537-522-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-523
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
BROWN (Light pinkish brown)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-523-01 4 in 1 TUBE
2 NDC:13537-523-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-524
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
ORANGE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-524-01 4 in 1 TUBE
2 NDC:13537-524-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


LBEL HYDRATESS

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-525
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 0.071 g
OXYBENZONE OXYBENZONE 0.016 g

Inactive Ingredients

Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE
TRIDECYL TRIMELLITATE
MICA
TRIDECYL STEARATE
HIGH DENSITY POLYETHYLENE
carnauba wax
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
PHENOXYETHANOL
COCONUT OIL
.ALPHA.-TOCOPHEROL ACETATE
Aloe Vera Leaf
SILICON DIOXIDE
SHEA BUTTER
palm oil
LEVANT COTTONSEED OIL
DIMETHICONE
CAPRYLYL GLYCOL
LINSEED OIL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
CERAMIDE 3
PROPYLPARABEN
Tocopherol
D&C RED NO. 7
ALUMINUM OXIDE
titanium dioxide
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
FD&C BLUE NO. 1
D&C RED NO. 27

Product Characteristics

Color
PURPLE (Brownish purple)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13537-525-01 4 in 1 TUBE
2 NDC:13537-525-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-27


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Be sure to consult your doctor before taking any medication!
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