Label: 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

  • NDC Code(s): 58411-594-60, 58411-594-61, 58411-595-60, 58411-595-61, view more
    58411-596-60, 58411-596-61, 58411-597-60, 58411-597-61, 58411-598-60, 58411-598-61, 58411-599-60, 58411-599-61, 58411-600-60, 58411-600-61, 58411-601-60, 58411-601-61, 58411-602-60, 58411-602-61, 58411-603-60, 58411-603-61, 58411-604-60, 58411-604-61, 58411-605-60, 58411-605-61, 58411-606-60, 58411-606-61, 58411-607-60, 58411-607-61, 58411-608-60, 58411-608-61, 58411-609-60, 58411-609-61, 58411-610-60, 58411-610-61, 58411-611-60, 58411-611-61, 58411-612-60, 58411-612-61, 58411-613-60, 58411-613-61
  • Packager: Laura Mercier Cosmetics
  • 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 1, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 5.5%Sunscreen
    Octisalate 3.0%Sunscreen
  • Uses

    • Helps prevent sunburn.
  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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
  • STORAGE AND HANDLING

    • Other information

      Protect this product in this container from excessive heat and direct sun

  • 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?

    Call toll free 1-888-637-2437 M-F 9am – 5pm CST

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0N1 Petal

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0N1 Petal
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0W1 Pearl

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0W1 Pearl
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1C0 Cameo

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1C0 Cameo
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1N2 Vanille

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1N2 Vanille
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1W1 Porcelain

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1W1 Porcelain
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2C1 Blush

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2C1 Blush
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2N1 Nude

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2N1 Nude
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2W1 Natural

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2W1 Natural
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3C1 Fawn

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3C1 Fawn
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3N1 Sand

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3N1 Sand
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3W1 Bisque

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3W1 Bisque
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4C1 Almond

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4C1 Almond
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4N1 Wheat

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4N1 Wheat
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4W1 Tawny

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4W1 Tawny
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5C1 Nutmeg

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5C1 Nutmeg
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5N1 Walnut

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5N1 Walnut
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5W1 Tan

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5W1 Tan
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6C1 Cacao

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6C1 Cacao
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6N1 Mocha

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6N1 Mocha
  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6W1 Ganache

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    OIL FREE
    Natural Skin Perfector

    Broad Spectrum
    SPF 20 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    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 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-594
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-594-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-594-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   0W1 PEARL
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-595
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-595-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-595-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   1C0 CAMEO
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-596
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-596-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-596-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   1N2 VANILLE
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-597
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-597-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-597-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   1W1 PORCELAIN
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-598
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-598-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-598-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   2C1 BLUSH
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-599
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-599-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-599-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   2N1 NUDE
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-600-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-600-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   2W1 NATURAL
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-601-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-601-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   3C1 FAWN
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-602-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-602-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   3N1 SAND
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-603-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-603-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   3W1 BISQUE
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-604-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-604-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   4C1 ALMOND
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-605
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-605-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-605-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   4N1 WHEAT
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-606
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-606-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-606-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   4W1 TAWNY
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-607
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-607-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-607-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   5C1 NUTMEG
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-608
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-608-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-608-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   5N1 WALNUT
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-609
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-609-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-609-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   5W1 TAN
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-610-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-610-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   6C1 CACAO
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-611
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-611-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-611-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   6N1 MOCHA
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-612
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-612-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-612-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN   6W1 GANACHE
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-613
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.827 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-613-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-613-611 in 1 CARTON11/30/2021
    225 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/30/2021
    Labeler - Laura Mercier Cosmetics (193691821)