DailyMed - 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 ....... NATURAL 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

Contains inactivated NDC Code(s)
NDC Code(s): 58411-594-60, 58411-594-61, 58411-595-60, 58411-595-61, view more
58411-596-60, 58411-596-61, 58411-597-60, 58411-597-61, 58411-598-60, 58411-598-61, 58411-599-60, 58411-599-61, 58411-600-60, 58411-600-61, 58411-601-60, 58411-601-61, 58411-602-60, 58411-602-61, 58411-603-60, 58411-603-61, 58411-604-60, 58411-604-61, 58411-605-60, 58411-605-61, 58411-606-60, 58411-606-61, 58411-607-60, 58411-607-61, 58411-608-60, 58411-608-61, 58411-609-60, 58411-609-61, 58411-610-60, 58411-610-61, 58411-611-60, 58411-611-61, 58411-612-60, 58411-612-61, 58411-613-60, 58411-613-61
Packager: Laura Mercier Cosmetics

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

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

Drug Label Information

Updated December 1, 2021

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

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

View All Sections

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

Active ingredients	Purpose
Octinoxate 5.5%	Sunscreen
Octisalate 3.0%	Sunscreen

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:58411-594
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-594-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-594-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-595
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-595-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-595-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-596
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-596-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-596-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-597
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-597-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-597-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-598
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-598-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-598-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-599
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-599-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-599-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-600
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-600-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-600-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-601
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-601-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-601-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-602
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-602-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-602-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-603
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-603-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-603-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-604
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-604-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-604-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-605
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-605-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-605-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-606
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-606-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-606-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-607
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-607-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-607-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-608
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-608-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-608-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-609
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-609-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-609-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-610
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-610-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-610-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-611
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-611-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-611-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-612
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-612-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-612-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

LAURA MERCIER TINTED MOISTURIZER 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:58411-613
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-613-60	1 in 1 CARTON	11/30/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58411-613-61	1 in 1 CARTON	11/30/2021
2		25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	11/30/2021

Labeler - Laura Mercier Cosmetics (193691821)

View All Sections

	NDC
1	58411-594-60 (inactivated)
2	58411-594-61 (inactivated)
3	58411-595-60 (inactivated)
4	58411-595-61 (inactivated)
5	58411-596-60 (inactivated)
6	58411-596-61 (inactivated)
7	58411-597-60 (inactivated)
8	58411-597-61 (inactivated)
9	58411-598-60 (inactivated)
10	58411-598-61 (inactivated)
11	58411-599-60 (inactivated)
12	58411-599-61 (inactivated)
13	58411-600-60 (inactivated)
14	58411-600-61 (inactivated)
15	58411-601-60 (inactivated)
16	58411-601-61 (inactivated)
17	58411-602-60 (inactivated)
18	58411-602-61 (inactivated)
19	58411-603-60 (inactivated)
20	58411-603-61 (inactivated)
21	58411-604-60 (inactivated)
22	58411-604-61 (inactivated)
23	58411-605-60 (inactivated)
24	58411-605-61 (inactivated)
25	58411-606-60 (inactivated)
26	58411-606-61 (inactivated)
27	58411-607-60 (inactivated)
28	58411-607-61 (inactivated)
29	58411-608-60 (inactivated)
30	58411-608-61 (inactivated)
31	58411-609-60 (inactivated)
32	58411-609-61 (inactivated)
33	58411-610-60 (inactivated)
34	58411-610-61 (inactivated)
35	58411-611-60 (inactivated)
36	58411-611-61 (inactivated)
37	58411-612-60 (inactivated)
38	58411-612-61 (inactivated)
39	58411-613-60 (inactivated)
40	58411-613-61 (inactivated)

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