Label: LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM CLAIRE 1 - BEIGE- octinoxate and titanium dioxide lotion
LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM CLAIRE 2 - BEIGE- octinoxate and titanium dioxide lotion
LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM CLAIRE 3 - BEIGE- octinoxate and titanium dioxide lotion
LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM CLAIRE 4 - BEIGE- octinoxate and titanium dioxide lotion
LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 5 - BEIGE- octinoxate and titanium dioxide lotion
LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 6 - BEIGE- octinoxate and titanium dioxide lotion
LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 7 - BEIGE- octinoxate and titanium dioxide lotion
LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM OBSCURE 8 - BROWN- octinoxate and titanium dioxide lotion
LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM OBSCURE 9 - BROWN- octinoxate and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-916-01, 14783-916-02, 14783-917-01, 14783-917-02, view more14783-918-01, 14783-918-02, 14783-919-01, 14783-919-02, 14783-920-01, 14783-920-02, 14783-921-01, 14783-921-02, 14783-922-01, 14783-922-02, 14783-923-01, 14783-923-02, 14783-924-01, 14783-924-02 - Packager: Ventura International 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 December 3, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
WATER, CYCLOPENTASILOXANE, POLYMETHYL METHACRYLATE, DIMETHICONE, CYCLOHEXASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, TRIMETHYLSILOXYSILICATE, GLYCERIN, SODIUM CHLORIDE, PEG/PPG-19/19 DIMETHICONE, HYDROXYACETOPHENONE, PHENOXYETHANOL, COFFEA ARABICA (COFFEE) SEEDCAKE EXTRACT, PEG/PPG-18/18 DIMETHICONE, ALUMINA, BUTYLENE GLYCOL, OCTYLDODECANOL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, CHLORPHENESIN, HYDROGEN DIMETHICONE, BHT, BENZYL ALCOHOL, POTASSIUM SORBATE, CARBOMER, POLYSORBATE 20, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7.
MAY CONTAIN:
TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE. - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - CLAIRE 1 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - CLAIRE 2 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - CLAIRE 3 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - CLAIRE 4 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - MEDIUM 5 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - MEDIUM 6 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - MEDIUM 7 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - OBSCURE 8 - BROWN
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - OBSCURE 9 - BROWN
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INGREDIENTS AND APPEARANCE
LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM CLAIRE 1 - BEIGE
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-916 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 Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0244 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PHENOXYETHANOL (UNII: HIE492ZZ3T) COFFEE BEAN (UNII: JFH385Y744) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-916-02 1 in 1 BOX 12/02/2019 1 NDC:14783-916-01 30 mL in 1 BOTTLE; 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 12/02/2019 LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM CLAIRE 2 - BEIGE
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-917 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 Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0244 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PHENOXYETHANOL (UNII: HIE492ZZ3T) COFFEE BEAN (UNII: JFH385Y744) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-917-02 1 in 1 BOX 12/02/2019 1 NDC:14783-917-01 30 mL in 1 BOTTLE; 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 12/02/2019 LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM CLAIRE 3 - BEIGE
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-918 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 Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0244 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PHENOXYETHANOL (UNII: HIE492ZZ3T) COFFEE BEAN (UNII: JFH385Y744) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-918-02 1 in 1 BOX 12/02/2019 1 NDC:14783-918-01 30 mL in 1 BOTTLE; 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 12/02/2019 LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM CLAIRE 4 - BEIGE
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-919 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 Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0244 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PHENOXYETHANOL (UNII: HIE492ZZ3T) COFFEE BEAN (UNII: JFH385Y744) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-919-02 1 in 1 BOX 12/02/2019 1 NDC:14783-919-01 30 mL in 1 BOTTLE; 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 12/02/2019 LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 5 - BEIGE
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-920 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 Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0244 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PHENOXYETHANOL (UNII: HIE492ZZ3T) COFFEE BEAN (UNII: JFH385Y744) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-920-02 1 in 1 BOX 12/02/2019 1 NDC:14783-920-01 30 mL in 1 BOTTLE; 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 12/02/2019 LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 6 - BEIGE
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-921 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 Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0244 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PHENOXYETHANOL (UNII: HIE492ZZ3T) COFFEE BEAN (UNII: JFH385Y744) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-921-02 1 in 1 BOX 12/02/2019 1 NDC:14783-921-01 30 mL in 1 BOTTLE; 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 12/02/2019 LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM MEDIUM 7 - BEIGE
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-922 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 Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0244 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PHENOXYETHANOL (UNII: HIE492ZZ3T) COFFEE BEAN (UNII: JFH385Y744) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-922-02 1 in 1 BOX 12/02/2019 1 NDC:14783-922-01 30 mL in 1 BOTTLE; 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 12/02/2019 LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM OBSCURE 8 - BROWN
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-923 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 Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0244 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PHENOXYETHANOL (UNII: HIE492ZZ3T) COFFEE BEAN (UNII: JFH385Y744) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-923-02 1 in 1 BOX 12/02/2019 1 NDC:14783-923-01 30 mL in 1 BOTTLE; 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 12/02/2019 LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20 FM OBSCURE 9 - BROWN
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-924 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 Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.0244 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL) PHENOXYETHANOL (UNII: HIE492ZZ3T) COFFEE BEAN (UNII: JFH385Y744) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECANOL (UNII: 461N1O614Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZYL ALCOHOL (UNII: LKG8494WBH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-924-02 1 in 1 BOX 12/02/2019 1 NDC:14783-924-01 30 mL in 1 BOTTLE; 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 12/02/2019 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-916, 14783-917, 14783-918, 14783-919, 14783-920, 14783-921, 14783-922, 14783-923, 14783-924)