LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 0N1 PETAL- octinoxate and octisalate cream LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 0W1 PEARL- octinoxate and octisalate cream LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 1C .......TURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 6C1 CACAO- octinoxate and octisalate cream LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 6N1 MOCHA- octinoxate and octisalate cream LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN 6W1 GANACHE- octinoxate and octisalate cream

Laura Mercier Tinted Moisturizer Oil Free Natural Skin Perfector Broad Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

Laura Mercier Tinted Moisturizer Oil Free Natural Skin Perfector Broad Spectrum SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Laura Mercier US Buyer LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 5.5%	Sunscreen
Octisalate 3.0%	Sunscreen

Uses

• Helps prevent sunburn.

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

STORAGE AND HANDLING

• Other information

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

Inactive Ingredients

WATER, DISILOXANE, PEG-30 DIPOLYHYDROXYSTEARATE, C12-15 ALKYL BENZOATE, ETHYLHEXYL PALMITATE, GLYCERIN, ISOHEXADECANE, CYCLOPENTASILOXANE, METHICONE, PPG-15 STEARYL ETHER, ISOPROPYL TITANIUM TRIISOSTEARATE, BORON NITRIDE, JOJOBA ESTERS, SQUALANE, MAGNESIUM STEARATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, DISODIUM EDTA, TOCOPHERYL ACETATE, LAURYL PCA, DIPOTASSIUM GLYCYRRHIZATE, PHENOXYETHANOL, SODIUM DEHYDROACETATE, METHYLPARABEN, PROPYLPARABEN. MAY CONTAIN: IRON OXIDES, TITANIUM DIOXIDE.

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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 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
OIL FREE
Natural Skin Perfector

Broad Spectrum
SPF 20 Sunscreen

50 mL / 1.7 FL. OZ. LIQ. US

INGREDIENTS AND APPEARANCE

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  0N1 PETAL
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-015-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-015-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-015-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-015-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  0W1 PEARL
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-016-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-016-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-016-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-016-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  1C0 CAMEO
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-017-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-017-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-017-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-017-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  1N2 VANILLE
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-018-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-018-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-018-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-018-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  1W1 PORCELAIN
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-019-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-019-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-019-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-019-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  2C1 BLUSH
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-020-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-020-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-020-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-020-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  2N1 NUDE
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-021-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-021-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-021-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-021-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  2W1 NATURAL
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-022-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-022-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-022-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-022-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  3C1 FAWN
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-023-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-023-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-023-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-023-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  3N1 SAND
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-024-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-024-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-024-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-024-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  3W1 BISQUE
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-025-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-025-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-025-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-025-05	0.03 mL in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  4C1 ALMOND
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-026-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-026-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-026-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-026-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  4N1 WHEAT
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-027-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-027-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-027-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-027-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  4W1 TAWNY
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-028-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-028-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-028-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-028-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  5C1 NUTMEG
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-029-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-029-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-029-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-029-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  5N1 WALNUT
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-030-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-030-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-030-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-030-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  5W1 TAN
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-031-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-031-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-031-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-031-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  6C1 CACAO
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-032-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-032-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-032-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-032-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  6N1 MOCHA
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-033-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-033-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-033-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-033-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

LAURA MERCIER TINTED MOISTURIZER OIL FREE NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 20 SUNSCREEN  6W1 GANACHE
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82761-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.827 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.542 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHICONE (20 CST) (UNII: 6777U11MKT)
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
BORON NITRIDE (UNII: 2U4T60A6YD)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82761-034-60	1 in 1 CARTON	08/31/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82761-034-61	1 in 1 CARTON	08/31/2022
2		25 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82761-034-00	30000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/05/2023
4	NDC: 82761-034-05	0.03 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/31/2022

Labeler - Laura Mercier US Buyer LLC (118344169)