LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 0N1 PETAL- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 0W1 PEARL- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 1C0 CAMEO- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 1W1 PORCELAIN- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 2N1 NUDE- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 2W1 NATURAL- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 3N1 SAND- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 3W1 BISQUE- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 4C1 ALMOND- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 4W1 TAWNY- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 5N1 WALNUT- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 5W1 TAN- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 6N1 MOCHA- avobenzone, homosalate, octisalate, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 6C1 CACAO- avobenzone, homosalate, octisalate, and octocrylene 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 Light Revealer Natural Skin Illuminator Broad Spectrum SPF 25 Sunscreen

Drug Facts

Active ingredientsPurpose
Avobenzone (3.0%)Sunscreen
Homosalate (5.0%)Sunscreen
Octisalate (5.0%)Sunscreen
Octocrylene (3.0%)Sunscreen

Uses

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

Inactive ingredients

Water, Butyloctyl Salicylate, Butylene Glycol, Octyldodecyl Neopentanoate, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Ascophyllum Nodosum Extract, Silica, Ethylhexylglycerin, Cetearyl Alcohol, Coco-Glucoside, Citric Acid, Batyl Alcohol, BIS-PEG/PPG-14/14 Dimethicone, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Potassium Hydroxide, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Xanthan Gum, Saccharide Isomerate, Sodium Citrate, Tin Oxide, Phenoxyethanol, Potassium Sorbate. May Contain: Iron Oxides, Mica, Titanium Dioxide.

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
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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 - 1W1 Porcelain

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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 - 2N1 Nude

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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 - 3N1 Sand

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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
PARIS | NEW YORK

TINTED MOISTURIZER
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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 - 5N1 Walnut

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 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 - 6N1 Mocha

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6N1 Mocha

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
LIGHT REVEALER

Natural Skin Illuminator

Broad Spectrum
SPF 25 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6C1 Cacao
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 0N1 PETAL 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-824
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-824-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 0W1 PEARL 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-825
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-825-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 1C0 CAMEO 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-826
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-826-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 1W1 PORCELAIN 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-827
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-827-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 2N1 NUDE 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-828
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-828-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 2W1 NATURAL 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-829
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-829-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 3N1 SAND 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-830
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-830-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 3W1 BISQUE 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-831
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-831-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 4C1 ALMOND 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-832
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-832-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 4W1 TAWNY 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-833
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-833-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 5N1 WALNUT 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-834
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-834-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 5W1 TAN 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-835
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-835-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 6N1 MOCHA 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-836
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-836-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
LAURA MERCIER TINTED MOISTURIZER LIGHT REVEALER NATURAL SKIN ILLUMINATOR BROAD SPECTRUM SPF 25 SUNSCREEN 6C1 CACAO 
avobenzone, homosalate, octisalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-837
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.53 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.55 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.55 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.53 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BATILOL (UNII: 39YR661C4U)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-837-601 in 1 CARTON12/01/2021
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 FINALpart35212/01/2021
Labeler - Laura Mercier Cosmetics (193691821)

Revised: 11/2021
Document Id: 9e4381d2-1e75-48a1-b98d-6f330c1267d9
Set id: dccba593-bb65-428b-bfbf-bca636155156
Version: 1
Effective Time: 20211129
 
Laura Mercier Cosmetics