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

Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Laura Mercier Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

AVOBENZONE 2.5%

OCTINOXATE 7.49%

OCTOCRYLENE 2.0%

OXYBENZONE 1.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • children under 6 months of age: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating

Inactive ingredients

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

Other information

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0N1 - Petal

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0W1 - Pearl

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1C0 - Cameo

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1N2 - Vanille

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2C1 - Blush

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2N1 - Nude

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3N1 - Sand

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4N1 - Wheat

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4W1 - Tawny

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5N1 - Walnut

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

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

LAURA MERCIER
PARIS | NEW YORK

TINTED MOISTURIZER
Natural Skin Perfector

Broad Spectrum
SPF 30 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-803
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-803-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-803-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-804
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-804-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-804-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   1C0 CAMEO
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-805
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-805-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-805-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   1N2 VANILLE
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-806
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-806-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-806-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-807
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-807-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-807-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-808
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-808-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-808-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-809
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-809-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-809-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-810
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-810-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-810-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-811
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-811-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-811-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-812
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-812-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-812-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-813
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-813-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-813-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-814
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-814-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-814-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   4N1 WHEAT
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-815
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-815-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-815-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-816
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-816-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-816-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-817
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-817-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-817-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-818
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-818-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-818-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-819
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-819-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-819-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-820
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-820-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-820-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   6W1 GANACHE
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-821
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-821-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-821-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN   6N1 MOCHA
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-822
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.5 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 TYPE I (UNII: U333RI6EB7)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TREHALOSE (UNII: B8WCK70T7I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SHEA BUTTER (UNII: K49155WL9Y)
MACADAMIA OIL (UNII: 515610SU8C)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ISOSTEARIC ACID (UNII: X33R8U0062)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-822-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-822-61	1 in 1 CARTON	11/30/2021
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	11/30/2021

Labeler - Laura Mercier Cosmetics (193691821)