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 SPECTRUM SPF 30 SUNSCREEN 1C0 CAMEO- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 1N2 VANILLE- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 1W1 PORCELAIN- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 2C1 BLUSH- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 2N1 NUDE- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 2W1 NATURAL- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 3C1 FAWN- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 3N1 SAND- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 3W1 BISQUE- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 4C1 ALMOND- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 4N1 WHEAT- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 4W1 TAWNY- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 5C1 NUTMEG- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 5N1 WALNUT- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 5W1 TAN- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 6C1 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 Cosmetics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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

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 - 0N1 - Petal

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 - 0W1 - Pearl

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 - 1C0 - Cameo

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 - 1N2 - Vanille

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 - 1W1 - Porcelain

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 - 2C1 - Blush

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 - 2N1 - Nude

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 - 2W1 - Natural

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 - 3C1 Fawn-

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 - 3N1 - Sand

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 - 3W1 - Bisque

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 - 4C1 - Almond

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 - 4N1 - Wheat

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 - 4W1 - Tawny

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 - 5C1 - Nutmeg

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 - 5N1 - Walnut

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 - 5W1 - Tan

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 - 6C1 - Cacao

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 - 6W1 - Ganache

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

Principal Display Panel - 50 mL Tube Carton - 6N1 - Mocha

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

Labeler - Laura Mercier Cosmetics (193691821)

Revised: 12/2021

Document Id: 3b9cad44-a8ab-435f-b9f7-f2266b227465

Set id: 8e2deaf1-4d71-47e4-ab6e-cc1599b68a41

Version: 1

Effective Time: 20211202

Laura Mercier Cosmetics