Label: LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 0N1 PETAL- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 0W1 PEARL- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPE .......CACAO- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 6W1 GANACHE- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 6N1 MOCHA- avobenzone, octinoxate, octocrylene, and oxybenzone cream

  • NDC Code(s): 58411-803-60, 58411-803-61, 58411-804-60, 58411-804-61, view more
    58411-805-60, 58411-805-61, 58411-806-60, 58411-806-61, 58411-807-60, 58411-807-61, 58411-808-60, 58411-808-61, 58411-809-60, 58411-809-61, 58411-810-60, 58411-810-61, 58411-811-60, 58411-811-61, 58411-812-60, 58411-812-61, 58411-813-60, 58411-813-61, 58411-814-60, 58411-814-61, 58411-815-60, 58411-815-61, 58411-816-60, 58411-816-61, 58411-817-60, 58411-817-61, 58411-818-60, 58411-818-61, 58411-819-60, 58411-819-61, 58411-820-60, 58411-820-61, 58411-821-60, 58411-821-61, 58411-822-60, 58411-822-61
  • 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 2, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    AVOBENZONE 2.5%

    OCTINOXATE 7.49%

    OCTOCRYLENE 2.0%

    OXYBENZONE 1.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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
      • children under 6 months of age: Ask a doctor
    • 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 value 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-sleeved shirts, pants, hats, and sunglasses
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
  • Inactive ingredients

    WATER, GLYCERIN, BUTYLENE GLYCOL, DIMETHICONE, PEG/PPG-14/7 DIMETHYL ETHER, HYDROGENATED POLYDECENE, PEG-5 GLYCERYL STEARATE, ISODODECANE, SILICA, PHENYL TRIMETHICONE, TREHALOSE, PHENOXYETHANOL, TOCOPHEROL, BUTYROSPERMUM PARKII (SHEA) BUTTER, MACADAMIA TERNIFOLIA SEED OIL, ALEURITES MOLUCCANUS SEED OIL, RHUS VERNICIFLUA PEEL WAX, TAMARINDUS INDICA SEED GUM, SACCHARIDE ISOMERATE, PENTYLENE GLYCOL, ISOSTEARIC ACID, GLYCERYL STEARATE SE, POLYSILICONE-11, BEHENYL ALCOHOL, BEHENIC ACID, STEARIC ACID, BATYL ALCOHOL, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, PEG-30 PHYTOSTEROL, DISODIUM EDTA, SODIUM METAPHOSPHATE, CARBOMER, POLYACRYLATE CROSSPOLYMER-6, POTASSIUM HYDROXIDE, BHT, SODIUM CITRATE, CITRIC ACID, T-BUTYL ALCOHOL. MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES.

  • Other information

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

  • 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 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 - 6W1 - Ganache

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

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

    LAURA MERCIER
    PARIS | NEW YORK

    TINTED MOISTURIZER
    Natural Skin Perfector

    Broad Spectrum
    SPF 30 Sunscreen

    50 mL / 1.7 FL. OZ. LIQ. US

    Principal Display Panel - 50 mL Tube Carton - 6N1 - Mocha
  • INGREDIENTS AND APPEARANCE
    LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   0N1 PETAL
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-803
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-803-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-803-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   0W1 PEARL
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-804-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-804-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   1C0 CAMEO
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-805-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-805-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   1N2 VANILLE
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-806
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-806-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-806-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   1W1 PORCELAIN
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-807
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-807-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-807-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   2C1 BLUSH
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-808
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-808-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-808-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   2N1 NUDE
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-809
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-809-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-809-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   2W1 NATURAL
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-810-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-810-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   3C1 FAWN
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-811
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-811-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-811-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   3N1 SAND
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-812-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-812-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   3W1 BISQUE
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-813
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-813-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-813-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   4C1 ALMOND
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-814
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-814-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-814-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   4N1 WHEAT
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-815
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-815-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-815-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   4W1 TAWNY
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-816
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-816-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-816-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   5C1 NUTMEG
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-817
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-817-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-817-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   5N1 WALNUT
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-818
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-818-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-818-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   5W1 TAN
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-819
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-819-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-819-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   6C1 CACAO
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-820
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-820-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-820-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   6W1 GANACHE
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-821
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-821-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-821-611 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 NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   6N1 MOCHA
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-822
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.745 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BEHENIC ACID (UNII: H390488X0A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BATILOL (UNII: 39YR661C4U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    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:58411-822-601 in 1 CARTON11/30/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:58411-822-611 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)