LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 1C1 CAMEO- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 1W1 PORCELAIN- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 2C1 BLUSH- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 2W1 BISQUE- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 2W2 NUDE- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 2W3 NATURAL- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM 20 SUNSCREEN 3C1 FAWN- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 3W1 OCHRE- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 3W2 SAND- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 4C1 ALMOND- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 4W1 TAWNY- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 5C1 CARAMEL- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 5W1 TAN- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 6C1 WALNUT- octinoxate and octisalate cream 
LAURA MERCIER TINTED MOISTURIZER OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 6W1 MOCHA- octinoxate and octisalate cream 
Laura Mercier Cosmetics

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.

----------

Laura Mercier Tinted Moisturizer
Oil Free Broad Spectrum

Drug Facts

Active ingredients

Octinoxate (5.5%), Octisalate (3.0%)

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 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 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
  • Children under 6 months of age: Ask a doctor

Other information

Protect the 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, Phenoxyethanol, Boron Nitride, Jojoba Esters, Magnesium Stearate, Sodium Dehydroacetate, Squalane, Methicone, Disodium EDTA, Methylparaben, Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate, Propylparaben, Lauryl PCA, Tocopheryl Acetate, PPG-15 Stearyl Ether, Dipotassium Glycyrrhizate, Isopropyl Titanium Triisostearate. May Contain: Titanium Dioxide, Iron Oxides.

Questions or comments?

Call 1-888-637-2437, M – F 9am – 5pm CST.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1C1 CAMEO

laura mercier

TINTED MOISTURIZER
OIL FREE

BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1C1 CAMEO

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1W1 PORCELAIN

laura mercier

TINTED MOISTURIZER
OIL FREE

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

TINTED MOISTURIZER
OIL FREE

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 - 2W1 BISQUE

laura mercier

TINTED MOISTURIZER
OIL FREE

BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2W1 BISQUE

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2W2 NUDE

laura mercier

TINTED MOISTURIZER
OIL FREE

BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2W2 NUDE

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2W3 NATURAL

laura mercier

TINTED MOISTURIZER
OIL FREE

BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2W3 NATURAL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3C1 FAWN

laura mercier

TINTED MOISTURIZER
OIL FREE

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 - 3W1 OCHRE

laura mercier

TINTED MOISTURIZER
OIL FREE

BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3W1 OCHRE

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3W2 SAND

laura mercier

TINTED MOISTURIZER
OIL FREE

BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3W2 SAND

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4C1 ALMOND

laura mercier

TINTED MOISTURIZER
OIL FREE

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 - 4W1 TAWNY

laura mercier

TINTED MOISTURIZER
OIL FREE

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 CARAMEL

laura mercier

TINTED MOISTURIZER
OIL FREE

BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5C1 CARAMEL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5W1 TAN

laura mercier

TINTED MOISTURIZER
OIL FREE

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 WALNUT

laura mercier

TINTED MOISTURIZER
OIL FREE

BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6C1 WALNUT

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6W1 MOCHA

laura mercier

TINTED MOISTURIZER
OIL FREE

BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6W1 MOCHA
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 1C1 CAMEO
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-374
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-374-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 1W1 PORCELAIN
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-375
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-375-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 2C1 BLUSH
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-376
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-376-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 2W1 BISQUE
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-377
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-377-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 2W2 NUDE
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-378-401 in 1 CARTON08/01/201511/30/2021
115 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-378-601 in 1 CARTON08/01/201511/30/2021
250 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 2W3 NATURAL
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-381
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-381-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM 20 SUNSCREEN 3C1 FAWN
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-382
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-382-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 3W1 OCHRE
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-383
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-383-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 3W2 SAND
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-384
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-384-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 4C1 ALMOND
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-386
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-386-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 4W1 TAWNY
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-387
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-387-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 5C1 CARAMEL
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-388
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-388-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 5W1 TAN
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-389
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-389-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 6C1 WALNUT
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-390
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-390-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
LAURA MERCIER TINTED MOISTURIZER  OIL FREE BROAD SPECTRUM SPF 20 SUNSCREEN 6W1 MOCHA
octinoxate and octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-391
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
SQUALANE (UNII: GW89575KF9)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROUS OXIDE (UNII: G7036X8B5H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-391-601 in 1 CARTON08/01/201511/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201511/30/2021
Labeler - Laura Mercier Cosmetics (193691821)

Revised: 11/2021
 
Laura Mercier Cosmetics