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, ox .......ER 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 Tinted Moisturizer Broad Spectrum SPF 30 Sunscreen - 6W1 Mocha by

Drug Labeling and Warnings

Laura Mercier Tinted Moisturizer Broad Spectrum SPF 30 Sunscreen - 6W1 Mocha by is a Otc medication manufactured, distributed, or labeled by Laura Mercier Cosmetics, SHISEIDO AMERICAS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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

INGREDIENTS AND APPEARANCE

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 0N1 PETAL 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-514
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-514-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-514-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 0W1 PEARL 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-515
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-515-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-515-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 1C1 CAMEO 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-516
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-516-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-516-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 1N1 VANILLE 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-517
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-517-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-517-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 1W1 PORCELAIN 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-518
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-518-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-518-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 2C1 BLUSH 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-519
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-519-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-519-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 2N1 NUDE 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-520-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-520-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 2W1 NATURAL 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-521
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-521-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-521-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 3C1 FAWN 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-522
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-522-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-522-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 3N1 SAND 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-523
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-523-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-523-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 3W1 BISQUE 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-524
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-524-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-524-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 4C1 ALMOND 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-525
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-525-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-525-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 4N1 CHAI 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-526
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-526-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-526-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 4W1 TAWNY 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-527
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-527-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-527-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 5C1 NUTMEG 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-528
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-528-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-528-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 5N1 WALNUT 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-529
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-529-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-529-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 5W1 TAN 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-530
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-530-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-530-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 6C1 CACAO 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-531
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-531-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-531-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 6N1 CHESTNUT 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-532
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-532-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-532-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN - 6W1 MOCHA 
avobenzone, octinoxate, oxybenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-533
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
HYDROGENATED POLYDECENE (550 MW) (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)
CARBOXYPOLYMETHYLENE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-533-60	1 in 1 CARTON	01/01/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-533-61	1 in 1 CARTON	01/01/2020
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2020

Labeler - Laura Mercier Cosmetics (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(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)