Label: LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 1) - BEIGE- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 2) - BEIGE- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 3) - BEIGE- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 4) - BEIGE- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 5) - BROWN- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 6) - BROWN- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 7) - BROWN- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 8) - BROWN- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 9) - BROWN- octinoxate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-200-01, 14783-200-02, 14783-200-03, 14783-200-04, view more14783-201-05, 14783-201-06, 14783-201-07, 14783-201-08, 14783-202-09, 14783-202-10, 14783-202-11, 14783-202-12, 14783-203-13, 14783-203-14, 14783-203-15, 14783-203-16, 14783-204-17, 14783-204-18, 14783-204-19, 14783-204-20, 14783-205-21, 14783-205-22, 14783-205-23, 14783-205-24, 14783-206-25, 14783-206-26, 14783-206-27, 14783-206-28, 14783-207-29, 14783-207-30, 14783-207-31, 14783-207-32, 14783-208-33, 14783-208-34, 14783-208-35, 14783-208-36 - Packager: Ventura International LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 19, 2013
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 Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
-
Inactive ingredients
AQUA (WATER), CYCLOMETHICONE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, SODIUM CHLORIDE, PEG/PPG-18/18 DIMETHICONE, DIMETHICONE, NYLON-12 FLUORESCENT BRIGHTENER 230 SALT, DIMETHICONOL, DIAZOLIDINYL UREA, CETEARYL DIMETHICONE CROSSPOLYMER, METHYLPARABEN, PARFUM (FRAGRANCE), PROPYLPARABEN, POLYVINYLALCOHOL CROSSPOLYMER, SODIUM HYALURONATE.
- MAY CONTAIN
- 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) - Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Medium 6) - Brown
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Medium 7) - Brown
- 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 FILLING EFFECT FOUNDATION SPF 10 Â (CLAIRE 1) - BEIGE
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-200 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 Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)  cyclomethicone (UNII: NMQ347994Z)  cyclomethicone 5 (UNII: 0THT5PCI0R)  cyclomethicone 6 (UNII: XHK3U310BA)  sodium chloride (UNII: 451W47IQ8X)  peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  dimethicone (UNII: 92RU3N3Y1O)  diazolidinyl urea (UNII: H5RIZ3MPW4)  methylparaben (UNII: A2I8C7HI9T)  propylparaben (UNII: Z8IX2SC1OH)  hyaluronate sodium (UNII: YSE9PPT4TH)  titanium dioxide (UNII: 15FIX9V2JP)  ferric oxide yellow (UNII: EX438O2MRT)  ferrosoferric oxide (UNII: XM0M87F357)  ferric oxide red (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-200-02 1 in 1 BOX 1 NDC:14783-200-01 30 mL in 1 BOTTLE 2 NDC:14783-200-04 1 in 1 BOX 2 NDC:14783-200-03 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL FILLING EFFECT FOUNDATION SPF 10  (CLAIRE 2) - BEIGE
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-201 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 Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)  cyclomethicone (UNII: NMQ347994Z)  cyclomethicone 5 (UNII: 0THT5PCI0R)  cyclomethicone 6 (UNII: XHK3U310BA)  sodium chloride (UNII: 451W47IQ8X)  peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  dimethicone (UNII: 92RU3N3Y1O)  diazolidinyl urea (UNII: H5RIZ3MPW4)  methylparaben (UNII: A2I8C7HI9T)  propylparaben (UNII: Z8IX2SC1OH)  hyaluronate sodium (UNII: YSE9PPT4TH)  titanium dioxide (UNII: 15FIX9V2JP)  ferric oxide yellow (UNII: EX438O2MRT)  ferrosoferric oxide (UNII: XM0M87F357)  ferric oxide red (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-201-06 1 in 1 BOX 1 NDC:14783-201-05 30 mL in 1 BOTTLE 2 NDC:14783-201-08 1 in 1 BOX 2 NDC:14783-201-07 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL FILLING EFFECT FOUNDATION SPF 10  (CLAIRE 3) - BEIGE
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-202 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 Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)  cyclomethicone (UNII: NMQ347994Z)  cyclomethicone 5 (UNII: 0THT5PCI0R)  cyclomethicone 6 (UNII: XHK3U310BA)  sodium chloride (UNII: 451W47IQ8X)  peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  dimethicone (UNII: 92RU3N3Y1O)  diazolidinyl urea (UNII: H5RIZ3MPW4)  methylparaben (UNII: A2I8C7HI9T)  propylparaben (UNII: Z8IX2SC1OH)  hyaluronate sodium (UNII: YSE9PPT4TH)  titanium dioxide (UNII: 15FIX9V2JP)  ferric oxide yellow (UNII: EX438O2MRT)  ferrosoferric oxide (UNII: XM0M87F357)  ferric oxide red (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-202-10 1 in 1 BOX 1 NDC:14783-202-09 30 mL in 1 BOTTLE 2 NDC:14783-202-12 1 in 1 BOX 2 NDC:14783-202-11 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL FILLING EFFECT FOUNDATION SPF 10  (CLAIRE 4) - BEIGE
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-203 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 Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)  cyclomethicone (UNII: NMQ347994Z)  cyclomethicone 5 (UNII: 0THT5PCI0R)  cyclomethicone 6 (UNII: XHK3U310BA)  sodium chloride (UNII: 451W47IQ8X)  peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  dimethicone (UNII: 92RU3N3Y1O)  diazolidinyl urea (UNII: H5RIZ3MPW4)  methylparaben (UNII: A2I8C7HI9T)  propylparaben (UNII: Z8IX2SC1OH)  hyaluronate sodium (UNII: YSE9PPT4TH)  titanium dioxide (UNII: 15FIX9V2JP)  ferric oxide yellow (UNII: EX438O2MRT)  ferrosoferric oxide (UNII: XM0M87F357)  ferric oxide red (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-203-14 1 in 1 BOX 1 NDC:14783-203-13 30 mL in 1 BOTTLE 2 NDC:14783-203-16 1 in 1 BOX 2 NDC:14783-203-15 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL FILLING EFFECT FOUNDATION SPF 10  (MEDIUM 5) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-204 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 Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)  cyclomethicone (UNII: NMQ347994Z)  cyclomethicone 5 (UNII: 0THT5PCI0R)  cyclomethicone 6 (UNII: XHK3U310BA)  sodium chloride (UNII: 451W47IQ8X)  peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  dimethicone (UNII: 92RU3N3Y1O)  diazolidinyl urea (UNII: H5RIZ3MPW4)  methylparaben (UNII: A2I8C7HI9T)  propylparaben (UNII: Z8IX2SC1OH)  hyaluronate sodium (UNII: YSE9PPT4TH)  titanium dioxide (UNII: 15FIX9V2JP)  ferric oxide yellow (UNII: EX438O2MRT)  ferrosoferric oxide (UNII: XM0M87F357)  ferric oxide red (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-204-18 1 in 1 BOX 1 NDC:14783-204-17 30 mL in 1 BOTTLE 2 NDC:14783-204-20 1 in 1 BOX 2 NDC:14783-204-19 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL FILLING EFFECT FOUNDATION SPF 10  (MEDIUM 6) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-205 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 Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)  cyclomethicone (UNII: NMQ347994Z)  cyclomethicone 5 (UNII: 0THT5PCI0R)  cyclomethicone 6 (UNII: XHK3U310BA)  sodium chloride (UNII: 451W47IQ8X)  peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  dimethicone (UNII: 92RU3N3Y1O)  diazolidinyl urea (UNII: H5RIZ3MPW4)  methylparaben (UNII: A2I8C7HI9T)  propylparaben (UNII: Z8IX2SC1OH)  hyaluronate sodium (UNII: YSE9PPT4TH)  titanium dioxide (UNII: 15FIX9V2JP)  ferric oxide yellow (UNII: EX438O2MRT)  ferrosoferric oxide (UNII: XM0M87F357)  ferric oxide red (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-205-22 1 in 1 BOX 1 NDC:14783-205-21 30 mL in 1 BOTTLE 2 NDC:14783-205-24 1 in 1 BOX 2 NDC:14783-205-23 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL FILLING EFFECT FOUNDATION SPF 10  (MEDIUM 7) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-206 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 Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)  cyclomethicone (UNII: NMQ347994Z)  cyclomethicone 5 (UNII: 0THT5PCI0R)  cyclomethicone 6 (UNII: XHK3U310BA)  sodium chloride (UNII: 451W47IQ8X)  peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  dimethicone (UNII: 92RU3N3Y1O)  diazolidinyl urea (UNII: H5RIZ3MPW4)  methylparaben (UNII: A2I8C7HI9T)  propylparaben (UNII: Z8IX2SC1OH)  hyaluronate sodium (UNII: YSE9PPT4TH)  titanium dioxide (UNII: 15FIX9V2JP)  ferric oxide yellow (UNII: EX438O2MRT)  ferrosoferric oxide (UNII: XM0M87F357)  ferric oxide red (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-206-26 1 in 1 BOX 1 NDC:14783-206-25 30 mL in 1 BOTTLE 2 NDC:14783-206-28 1 in 1 BOX 2 NDC:14783-206-27 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL FILLING EFFECT FOUNDATION SPF 10  (OBSCURE 8) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-207 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 Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)  cyclomethicone (UNII: NMQ347994Z)  cyclomethicone 5 (UNII: 0THT5PCI0R)  cyclomethicone 6 (UNII: XHK3U310BA)  sodium chloride (UNII: 451W47IQ8X)  peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  dimethicone (UNII: 92RU3N3Y1O)  diazolidinyl urea (UNII: H5RIZ3MPW4)  methylparaben (UNII: A2I8C7HI9T)  propylparaben (UNII: Z8IX2SC1OH)  hyaluronate sodium (UNII: YSE9PPT4TH)  titanium dioxide (UNII: 15FIX9V2JP)  ferric oxide yellow (UNII: EX438O2MRT)  ferrosoferric oxide (UNII: XM0M87F357)  ferric oxide red (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-207-30 1 in 1 BOX 1 NDC:14783-207-29 30 mL in 1 BOTTLE 2 NDC:14783-207-32 1 in 1 BOX 2 NDC:14783-207-31 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL FILLING EFFECT FOUNDATION SPF 10  (OBSCURE 9) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-208 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 Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R)  cyclomethicone (UNII: NMQ347994Z)  cyclomethicone 5 (UNII: 0THT5PCI0R)  cyclomethicone 6 (UNII: XHK3U310BA)  sodium chloride (UNII: 451W47IQ8X)  peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  dimethicone (UNII: 92RU3N3Y1O)  diazolidinyl urea (UNII: H5RIZ3MPW4)  methylparaben (UNII: A2I8C7HI9T)  propylparaben (UNII: Z8IX2SC1OH)  hyaluronate sodium (UNII: YSE9PPT4TH)  titanium dioxide (UNII: 15FIX9V2JP)  ferric oxide yellow (UNII: EX438O2MRT)  ferrosoferric oxide (UNII: XM0M87F357)  ferric oxide red (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-208-34 1 in 1 BOX 1 NDC:14783-208-33 30 mL in 1 BOTTLE 2 NDC:14783-208-36 1 in 1 BOX 2 NDC:14783-208-35 3 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-200, 14783-201, 14783-202, 14783-203, 14783-204, 14783-205, 14783-206, 14783-207, 14783-208)
