DailyMed - 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 .......AO- 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

NDC Code(s): 82761-035-60, 82761-035-61, 82761-036-60, 82761-036-61, view more
82761-037-60, 82761-037-61, 82761-038-60, 82761-038-61, 82761-039-60, 82761-039-61, 82761-040-60, 82761-040-61, 82761-041-60, 82761-041-61, 82761-042-60, 82761-042-61, 82761-043-60, 82761-043-61, 82761-044-60, 82761-044-61, 82761-045-60, 82761-045-61, 82761-046-60, 82761-046-61, 82761-047-60, 82761-047-61, 82761-048-60, 82761-048-61, 82761-049-60, 82761-049-61, 82761-050-60, 82761-050-61, 82761-051-60, 82761-051-61, 82761-052-60, 82761-052-61, 82761-053-60, 82761-053-61, 82761-054-60, 82761-054-61
Packager: Laura Mercier US Buyer LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated October 4, 2023

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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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:82761-035
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
Packaging
1	NDC:82761-035-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-035-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-042
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
Packaging
1	NDC:82761-042-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-042-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-049
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
Packaging
1	NDC:82761-049-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-049-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-036
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
Packaging
1	NDC:82761-036-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-036-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-043
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
Packaging
1	NDC:82761-043-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-043-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-050
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
Packaging
1	NDC:82761-050-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-050-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-037
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
Packaging
1	NDC:82761-037-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-037-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-044
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
Packaging
1	NDC:82761-044-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-044-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-051
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
Packaging
1	NDC:82761-051-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-051-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-038
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
Packaging
1	NDC:82761-038-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-038-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-048
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
Packaging
1	NDC:82761-048-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-048-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-045
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
Packaging
1	NDC:82761-045-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-045-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-052
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82761-052-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-052-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-039
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
Packaging
1	NDC:82761-039-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-039-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-046
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
Packaging
1	NDC:82761-046-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-046-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-053
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
Packaging
1	NDC:82761-053-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-053-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-040
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
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)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82761-040-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-040-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-047
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
Packaging
1	NDC:82761-047-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-047-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-054
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
Packaging
1	NDC:82761-054-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-054-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

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:82761-041
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
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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 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
Packaging
1	NDC:82761-041-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:82761-041-61	1 in 1 CARTON	08/31/2022
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 Drug	M020	08/31/2022

Labeler - Laura Mercier US Buyer LLC (118344169)

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Dec 4, 2023	2 (current)	download
Sep 26, 2022	1	download

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	NDC
1	82761-035-60
2	82761-035-61
3	82761-036-60
4	82761-036-61
5	82761-037-60
6	82761-037-61
7	82761-038-60
8	82761-038-61
9	82761-039-60
10	82761-039-61
11	82761-040-60
12	82761-040-61
13	82761-041-60
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15	82761-042-60
16	82761-042-61
17	82761-043-60
18	82761-043-61
19	82761-044-60
20	82761-044-61
21	82761-045-60
22	82761-045-61
23	82761-046-60
24	82761-046-61
25	82761-047-60
26	82761-047-61
27	82761-048-60
28	82761-048-61
29	82761-049-60
30	82761-049-61
31	82761-050-60
32	82761-050-61
33	82761-051-60
34	82761-051-61
35	82761-052-60
36	82761-052-61
37	82761-053-60
38	82761-053-61
39	82761-054-60
40	82761-054-61

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