Label: LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 1) - BEIGE- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 2) - BEIGE- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 3) - BEIGE- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 4) - BEIGE- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 5) - BROWN- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 6) - BROWN- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 7) - BROWN- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 8) - BROWN- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 9) - BROWN- octinoxate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-257-01, 13537-257-02, 13537-258-03, 13537-258-04, view more13537-259-05, 13537-259-06, 13537-260-07, 13537-260-08, 13537-262-11, 13537-262-12, 13537-263-13, 13537-263-14, 13537-264-15, 13537-264-16, 13537-265-17, 13537-265-18, 13537-298-09, 13537-298-10 - Packager: Ventura Corporation 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 17, 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
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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
- Apply to the forehead, nose, chin and both cheeks.
Blend with CIrcular motion and spread softly without stretching the skin.
- Other information
-
Inactive ingredients
Water, cyclopentasiloxane, butylene glycol, cyclohexasiloxane, phenyl trimethicone, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, nylon-12 fluorescent brightener 230 salt, hexyl laurate, mannitol, glycerin, ethylene/acrylic acid copolymer, glycine soja (soybean) protein, peg/ppg-18/18 dimethicone, disteardimonium hectorite, sodium chloride, dimethicone, propylene glycol, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, diazolidinyl urea, hydrolyzed keratin, dimethiconol, sucrose, methylparaben, serine, fragrance, arginine, cyclodextrin, polyvinylalcohol crosspolymer, pca, bht, macrocystis pyrifera extract, yeast extract, alanine, propylparaben, hydrolyzed wheat protein, carbomer, pvp, threonine, polysorbate 20, disodium succinate, mourera fluviatilis extract, palmitoyl pentapeptide-4.
May contain: titanium dioxide, iron oxides, iron oxides, iron oxides,methicone.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claire 1 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claire 2 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claire 3 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claire 4 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medium 5 - BROWN
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medium 6 - BROWN
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medium 7 - BROWN
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Obscure 8 - BROWN
- PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Obscure 9 - BROWN
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INGREDIENTS AND APPEARANCE
LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 1) - BEIGE
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-257 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.045 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) MANNITOL (UNII: 3OWL53L36A) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SUCROSE (UNII: C151H8M554) METHYLPARABEN (UNII: A2I8C7HI9T) SERINE (UNII: 452VLY9402) ARGININE (UNII: 94ZLA3W45F) PIDOLIC ACID (UNII: SZB83O1W42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) YEAST (UNII: 3NY3SM6B8U) ALANINE (UNII: OF5P57N2ZX) PROPYLPARABEN (UNII: Z8IX2SC1OH) THREONINE (UNII: 2ZD004190S) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-257-02 1 in 1 BOX 1 NDC:13537-257-01 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 2) - BEIGE
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-258 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.045 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) MANNITOL (UNII: 3OWL53L36A) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SUCROSE (UNII: C151H8M554) METHYLPARABEN (UNII: A2I8C7HI9T) SERINE (UNII: 452VLY9402) ARGININE (UNII: 94ZLA3W45F) PIDOLIC ACID (UNII: SZB83O1W42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) YEAST (UNII: 3NY3SM6B8U) ALANINE (UNII: OF5P57N2ZX) PROPYLPARABEN (UNII: Z8IX2SC1OH) THREONINE (UNII: 2ZD004190S) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-258-04 1 in 1 BOX 1 NDC:13537-258-03 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 3) - BEIGE
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-259 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.045 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) MANNITOL (UNII: 3OWL53L36A) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SUCROSE (UNII: C151H8M554) METHYLPARABEN (UNII: A2I8C7HI9T) SERINE (UNII: 452VLY9402) ARGININE (UNII: 94ZLA3W45F) PIDOLIC ACID (UNII: SZB83O1W42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) YEAST (UNII: 3NY3SM6B8U) ALANINE (UNII: OF5P57N2ZX) PROPYLPARABEN (UNII: Z8IX2SC1OH) THREONINE (UNII: 2ZD004190S) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-259-06 1 in 1 BOX 1 NDC:13537-259-05 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 4) - BEIGE
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-260 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.045 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) MANNITOL (UNII: 3OWL53L36A) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SUCROSE (UNII: C151H8M554) METHYLPARABEN (UNII: A2I8C7HI9T) SERINE (UNII: 452VLY9402) ARGININE (UNII: 94ZLA3W45F) PIDOLIC ACID (UNII: SZB83O1W42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) YEAST (UNII: 3NY3SM6B8U) ALANINE (UNII: OF5P57N2ZX) PROPYLPARABEN (UNII: Z8IX2SC1OH) THREONINE (UNII: 2ZD004190S) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-260-08 1 in 1 BOX 1 NDC:13537-260-07 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 5) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-298 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.045 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) MANNITOL (UNII: 3OWL53L36A) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SUCROSE (UNII: C151H8M554) METHYLPARABEN (UNII: A2I8C7HI9T) SERINE (UNII: 452VLY9402) ARGININE (UNII: 94ZLA3W45F) PIDOLIC ACID (UNII: SZB83O1W42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) YEAST (UNII: 3NY3SM6B8U) ALANINE (UNII: OF5P57N2ZX) PROPYLPARABEN (UNII: Z8IX2SC1OH) THREONINE (UNII: 2ZD004190S) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-298-10 1 in 1 BOX 1 NDC:13537-298-09 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 6) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-262 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.045 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) MANNITOL (UNII: 3OWL53L36A) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SUCROSE (UNII: C151H8M554) METHYLPARABEN (UNII: A2I8C7HI9T) SERINE (UNII: 452VLY9402) ARGININE (UNII: 94ZLA3W45F) PIDOLIC ACID (UNII: SZB83O1W42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) YEAST (UNII: 3NY3SM6B8U) ALANINE (UNII: OF5P57N2ZX) PROPYLPARABEN (UNII: Z8IX2SC1OH) THREONINE (UNII: 2ZD004190S) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-262-12 1 in 1 BOX 1 NDC:13537-262-11 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 7) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-263 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.045 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) MANNITOL (UNII: 3OWL53L36A) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SUCROSE (UNII: C151H8M554) METHYLPARABEN (UNII: A2I8C7HI9T) SERINE (UNII: 452VLY9402) ARGININE (UNII: 94ZLA3W45F) PIDOLIC ACID (UNII: SZB83O1W42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) YEAST (UNII: 3NY3SM6B8U) ALANINE (UNII: OF5P57N2ZX) PROPYLPARABEN (UNII: Z8IX2SC1OH) THREONINE (UNII: 2ZD004190S) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-263-14 1 in 1 BOX 1 NDC:13537-263-13 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 8) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-264 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.045 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) MANNITOL (UNII: 3OWL53L36A) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SUCROSE (UNII: C151H8M554) METHYLPARABEN (UNII: A2I8C7HI9T) SERINE (UNII: 452VLY9402) ARGININE (UNII: 94ZLA3W45F) PIDOLIC ACID (UNII: SZB83O1W42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) YEAST (UNII: 3NY3SM6B8U) ALANINE (UNII: OF5P57N2ZX) PROPYLPARABEN (UNII: Z8IX2SC1OH) THREONINE (UNII: 2ZD004190S) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-264-16 1 in 1 BOX 1 NDC:13537-264-15 30 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/16/2013 LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 9) - BROWN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-265 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.045 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) MANNITOL (UNII: 3OWL53L36A) GLYCERIN (UNII: PDC6A3C0OX) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SUCROSE (UNII: C151H8M554) METHYLPARABEN (UNII: A2I8C7HI9T) SERINE (UNII: 452VLY9402) ARGININE (UNII: 94ZLA3W45F) PIDOLIC ACID (UNII: SZB83O1W42) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) YEAST (UNII: 3NY3SM6B8U) ALANINE (UNII: OF5P57N2ZX) PROPYLPARABEN (UNII: Z8IX2SC1OH) THREONINE (UNII: 2ZD004190S) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-265-18 1 in 1 BOX 1 NDC:13537-265-17 30 g in 1 BOTTLE 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 Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-257, 13537-258, 13537-259, 13537-260, 13537-298, 13537-262, 13537-263, 13537-264, 13537-265)
