LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 1 - BEIGE- octinoxate and zinc oxide liquid LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 2 - BEIGE- octinoxate and zinc oxide liquid LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 3 - BEIGE- octinoxate and zinc oxide liquid LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 4 - BEIGE- octinoxate and zinc oxide liquid LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 MEDIUM 5 - BEIGE- octinoxate and zinc oxide liquid LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 MEDIUM 6 - BEIGE- octinoxate and zinc oxide liquid LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 MEDIUM 7 - BEIGE- octinoxate and zinc oxide liquid LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 OBSCURE 8 - BEIGE- octinoxate and zinc oxide liquid LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 OBSCURE 9 - BEIGE- octinoxate and zinc oxide liquid LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 TONO HUT - BEIGE- octinoxate and zinc oxide liquid

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 by

Drug Labeling and Warnings

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 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 INGREDIENT

Active Ingredients	Purpose
OCTINOXATE 7.%	Sunscreen
ZINC OXIDE 7.2%	Sunscreen

Uses

• Helps prevent sunburn.

Warnings

• Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• For external use only.

• Do not use on damaged or broken skin.

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

• Stop use and ask a doctor if rash occurs.

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

DIMETHICONE, ALCOHOL DENAT., GLYCERIN, POLYSILICONE-11, MICA, PEG/PPG-18/18 DIMETHICONE, ZEA MAYS (CORN) STARCH, PEG-10 DIMETHICONE, BARIUM SULFATE, ALBIZIA JULIBRISSIN BARK EXTRACT, PHENOXYETHANOL, SILICA, METHYLPROPANEDIOL, TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, CHLORPHENESIN, SILANEDIOL SALICYLATE, DISTEARDIMONIUM HECTORITE, TROMETHAMINE, CERAMIDE 3, FRAGRANCE, GRIFOLA FRONDOSA FRUITING BODY EXTRACT, MALTODEXTRIN, LINALOOL, d-LIMONENE, ALPHA-ISOMETHYL IONONE.

MAY CONTAIN:
TITANIUM DIOXIDE , IRON OXIDES.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126.

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 1 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 2 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 3 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - CLAIRE 4 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - MEDIUM 5 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - MEDIUM 6 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - MEDIUM 7 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - OBSCURE 8 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - OBSCURE 9 - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

PRINCIPAL DISPLAY PANEL - 27 ml Tube Box - TONO HUT - BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

INGREDIENTS AND APPEARANCE

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   CLAIRE 1 - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-080-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-080-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   CLAIRE 2 - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-082-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-082-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   CLAIRE 3 - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-084-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-084-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   CLAIRE 4 - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-086-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-086-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   MEDIUM 5 - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-087
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-087-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-087-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   MEDIUM 6 - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-088
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-088-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-088-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   MEDIUM 7 - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-089
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-089-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-089-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   OBSCURE 8 - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-090-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-090-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   OBSCURE 9 - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-092
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-092-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-092-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25   TONO HUT - BEIGE
octinoxate and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.072 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
STARCH, CORN (UNII: O8232NY3SJ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
MAITAKE (UNII: A1U5YJI0Z8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-110-02	1 in 1 BOX	01/27/2017
1	NDC: 14783-110-01	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/27/2017

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	manufacture(14783-080, 14783-082, 14783-084, 14783-086, 14783-087, 14783-088, 14783-089, 14783-090, 14783-092, 14783-110)