LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 0N1 PETAL- octinoxate and octisalate cream LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 0W1 PEARL- octinoxate and octisalate cream LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 1C ....... NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 6C1 CACAO- octinoxate and octisalate cream LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 6N1 MOCHA- octinoxate and octisalate cream LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 6W1 GANACHE- octinoxate and octisalate cream
Laura Mercier Tinted Moisturizer Oil Free Natural Skin Perfector Broad Spectrum SPF 20 Sunscreen by
Drug Labeling and Warnings
Laura Mercier Tinted Moisturizer Oil Free Natural Skin Perfector Broad Spectrum SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Laura Mercier Cosmetics. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
-
Directions
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- For sunscreen use:
- STORAGE AND HANDLING
-
Inactive Ingredients
WATER, DISILOXANE, PEG-30 DIPOLYHYDROXYSTEARATE, C12-15 ALKYL BENZOATE, ETHYLHEXYL PALMITATE, GLYCERIN, ISOHEXADECANE, CYCLOPENTASILOXANE, METHICONE, PPG-15 STEARYL ETHER, ISOPROPYL TITANIUM TRIISOSTEARATE, BORON NITRIDE, JOJOBA ESTERS, SQUALANE, MAGNESIUM STEARATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, DISODIUM EDTA, TOCOPHERYL ACETATE, LAURYL PCA, DIPOTASSIUM GLYCYRRHIZATE, PHENOXYETHANOL, SODIUM DEHYDROACETATE, METHYLPARABEN, PROPYLPARABEN. MAY CONTAIN: IRON OXIDES, TITANIUM DIOXIDE.
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0N1 Petal
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0W1 Pearl
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1C0 Cameo
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1N2 Vanille
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1W1 Porcelain
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2C1 Blush
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2N1 Nude
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2W1 Natural
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3C1 Fawn
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3N1 Sand
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3W1 Bisque
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4C1 Almond
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4N1 Wheat
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4W1 Tawny
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5C1 Nutmeg
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5N1 Walnut
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5W1 Tan
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6C1 Cacao
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6N1 Mocha
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6W1 Ganache
-
INGREDIENTS AND APPEARANCE
LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 0N1 PETAL
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-594 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-594-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-594-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 0W1 PEARL
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-595 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-595-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-595-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 1C0 CAMEO
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-596 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-596-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-596-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 1N2 VANILLE
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-597 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-597-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-597-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 1W1 PORCELAIN
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-598 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-598-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-598-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 2C1 BLUSH
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-599 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-599-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-599-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 2N1 NUDE
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-600-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-600-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 2W1 NATURAL
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-601 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-601-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-601-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 3C1 FAWN
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-602 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-602-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-602-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 3N1 SAND
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-603-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-603-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 3W1 BISQUE
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-604 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-604-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-604-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 4C1 ALMOND
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-605 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-605-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-605-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 4N1 WHEAT
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-606 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-606-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-606-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 4W1 TAWNY
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-607 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-607-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-607-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 5C1 NUTMEG
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-608 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-608-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-608-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 5N1 WALNUT
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-609 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-609-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-609-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 5W1 TAN
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-610 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-610-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-610-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 6C1 CACAO
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-611 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-611-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-611-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 6N1 MOCHA
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-612 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-612-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-612-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 6W1 GANACHE
octinoxate and octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-613 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.827 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.542 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HEXAMETHYLDISILOXANE (UNII: D7M4659BPU) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHICONE (20 CST) (UNII: 6777U11MKT) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) BORON NITRIDE (UNII: 2U4T60A6YD) SQUALANE (UNII: GW89575KF9) MAGNESIUM STEARATE (UNII: 70097M6I30) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) LAURYL PIDOLATE (UNII: 29C5O2BJYA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-613-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC: 58411-613-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; 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 11/30/2021 Labeler - Laura Mercier Cosmetics (193691821)
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