LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 0N1 PETAL- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 0W1 PEARL- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 1C1 CAMEO- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 1N1 VANILLE- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 1W1 PORCELAIN- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 2C1 BLUSH- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 2N1 NUDE- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 2W1 NATURAL- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 3C1 FAWN- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 3N1 SAND- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 3W1 BISQUE- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 4C1 ALMOND- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 4N1 CHAI- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 4W1 TAWNY- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 5C1 NUTMEG- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 5N1 WALNUT- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 5W1 TAN- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 6C1 CACAO- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 6N1 CHESTNUT- avobenzone, octinoxate, oxybenzone, and octocrylene cream 
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 6W1 MOCHA- avobenzone, octinoxate, oxybenzone, 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 Broad Spectrum SPF 30 Sunscreen

Drug Facts

Active ingredientsPurpose
Avobenzone 2.5%Sunscreen
Octinoxate 7.49%Sunscreen
Octocrylene 2.0%Sunscreen
Oxybenzone 1.0%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
    • 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, 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.

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 0N1 Petal

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 0N1 Petal

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 0W1 Pearl

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 0W1 Pearl

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 1C1 Cameo

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 1C1 Cameo

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 1N1 Vanille

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 1N1 Vanille

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 1W1 Porcelain

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 1W1 Porcelain

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 2C1 Blush

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 2C1 Blush

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 2N1 Nude

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 2N1 Nude

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 2W1 Natural

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 2W1 Natural

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 3C1 Fawn

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 3C1 Fawn

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 3N1 Sand

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 3N1 Sand

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 3W1 Bisque

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 3W1 Bisque

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 4C1 Almond

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 4C1 Almond

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 4N1 Chai

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 4N1 Chai

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 4W1 Tawny

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 4W1 Tawny

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 5C1 Nutmeg

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 5C1 Nutmeg

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 5N1 Walnut

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 5N1 Walnut

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 5W1 Tan

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 5W1 Tan

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 6C1 Cacao

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 6C1 Cacao

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 6N1 Chestnut

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 6N1 Chestnut

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - 6W1 Mocha

LAURA MERCIER

PARIS | NEW YORK

TINTED MOISTURIZER

Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

25 mL / 0.8 FL. OZ. LIQ. US

Principal Display Panel - 25 mL Tube Carton - 6W1 Mocha
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 0N1 PETAL 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-514
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-514-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-514-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 0W1 PEARL 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-515
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-515-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-515-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 1C1 CAMEO 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-516
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-516-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-516-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 1N1 VANILLE 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-517
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-517-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-517-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 1W1 PORCELAIN 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-518
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-518-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-518-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 2C1 BLUSH 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-519
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-519-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-519-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 2N1 NUDE 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-520
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-520-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-520-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 2W1 NATURAL 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-521
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-521-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-521-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 3C1 FAWN 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-522
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-522-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-522-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 3N1 SAND 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-523
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-523-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-523-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 3W1 BISQUE 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-524
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-524-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-524-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 4C1 ALMOND 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-525
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-525-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-525-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 4N1 CHAI 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-526
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-526-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-526-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 4W1 TAWNY 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-527
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-527-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-527-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 5C1 NUTMEG 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-528
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-528-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-528-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 5N1 WALNUT 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-529
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-529-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-529-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 5W1 TAN 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-530
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-530-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-530-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 6C1 CACAO 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-531
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-531-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-531-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 6N1 CHESTNUT 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-532
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-532-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-532-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 6W1 MOCHA 
avobenzone, octinoxate, oxybenzone, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-533
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1 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)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SHEA BUTTER (UNII: K49155WL9Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DOCOSANOL (UNII: 9G1OE216XY)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)  
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
TALC (UNII: 7SEV7J4R1U)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-533-601 in 1 CARTON01/01/202011/30/2021
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:58411-533-611 in 1 CARTON01/01/202011/30/2021
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 FINALpart35201/01/202011/30/2021
Labeler - Laura Mercier Cosmetics (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICAS INC.782677132MANUFACTURE(58411-514, 58411-515, 58411-516, 58411-517, 58411-518, 58411-519, 58411-520, 58411-521, 58411-522, 58411-523, 58411-524, 58411-525, 58411-526, 58411-527, 58411-528, 58411-529, 58411-530, 58411-531, 58411-532, 58411-533) , ANALYSIS(58411-514, 58411-515, 58411-516, 58411-517, 58411-518, 58411-519, 58411-520, 58411-521, 58411-522, 58411-523, 58411-524, 58411-525, 58411-526, 58411-527, 58411-528, 58411-529, 58411-530, 58411-531, 58411-532, 58411-533)

Revised: 11/2021
 
Laura Mercier Cosmetics