DailyMed - 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

Contains inactivated NDC Code(s)
NDC Code(s): 43596-0038-1, 43596-0038-2, 43596-0039-1, 43596-0039-2, view more
43596-0040-1, 43596-0040-2, 43596-0041-1, 43596-0041-2, 43596-0042-1, 43596-0042-2, 43596-0043-1, 43596-0043-2, 43596-0044-1, 43596-0044-2, 43596-0045-1, 43596-0045-2, 43596-0046-1, 43596-0046-2, 43596-0047-1, 43596-0047-2
Packager: Ventura Corporation LTD

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

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

Drug Label Information

Updated November 17, 2019

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 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 Corp, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 27 ml Bottle 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 Bottle 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 Bottle 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 Bottle 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 Bottle 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 Bottle 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 Bottle 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 Bottle 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 Bottle 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 Bottle Box - TONO HUT- BEIGE

L'BEL

CONCENTRÉ
TOTAL

BASE SÉRUM

ultra-fluid foundation
SPF 25

27 ml e (0.91 fl. oz.)

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

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:43596-0038
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0038-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0038-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	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:43596-0039
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0039-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0039-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	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:43596-0040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0040-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0040-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	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:43596-0041
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0041-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0041-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	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:43596-0042
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0042-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0042-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	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:43596-0043
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0043-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0043-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	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:43596-0044
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0044-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0044-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	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:43596-0045
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0045-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0045-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	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:43596-0046
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0046-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0046-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	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:43596-0047
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43596-0047-2	1 in 1 BOX	01/27/2017
1	NDC:43596-0047-1	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(43596-0038, 43596-0039, 43596-0040, 43596-0041, 43596-0042, 43596-0043, 43596-0044, 43596-0045, 43596-0046, 43596-0047)

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Published Date (What is this?)	Version	Files
Nov 18, 2019	2 (current)	download
Jan 31, 2017	1	download

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	NDC
1	43596-0038-1
2	43596-0038-2 (inactivated)
3	43596-0039-1
4	43596-0039-2 (inactivated)
5	43596-0040-1
6	43596-0040-2 (inactivated)
7	43596-0041-1
8	43596-0041-2 (inactivated)
9	43596-0042-1
10	43596-0042-2 (inactivated)
11	43596-0043-1
12	43596-0043-2 (inactivated)
13	43596-0044-1
14	43596-0044-2 (inactivated)
15	43596-0045-1
16	43596-0045-2 (inactivated)
17	43596-0046-1
18	43596-0046-2 (inactivated)
19	43596-0047-1
20	43596-0047-2 (inactivated)

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Number of versions: 2

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