Label: LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 0N1 PETAL- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 0W1 PEARL- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPE .......CACAO- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 6W1 GANACHE- avobenzone, octinoxate, octocrylene, and oxybenzone cream
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN 6N1 MOCHA- avobenzone, octinoxate, octocrylene, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-803-60, 58411-803-61, 58411-804-60, 58411-804-61, view more58411-805-60, 58411-805-61, 58411-806-60, 58411-806-61, 58411-807-60, 58411-807-61, 58411-808-60, 58411-808-61, 58411-809-60, 58411-809-61, 58411-810-60, 58411-810-61, 58411-811-60, 58411-811-61, 58411-812-60, 58411-812-61, 58411-813-60, 58411-813-61, 58411-814-60, 58411-814-61, 58411-815-60, 58411-815-61, 58411-816-60, 58411-816-61, 58411-817-60, 58411-817-61, 58411-818-60, 58411-818-61, 58411-819-60, 58411-819-61, 58411-820-60, 58411-820-61, 58411-821-60, 58411-821-61, 58411-822-60, 58411-822-61 - Packager: Laura Mercier Cosmetics
- Category: HUMAN OTC DRUG LABEL
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 2, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
-
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- children under 6 months of age: Ask a doctor
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
-
For sunscreen use:
-
Inactive ingredients
WATER, GLYCERIN, BUTYLENE GLYCOL, DIMETHICONE, PEG/PPG-14/7 DIMETHYL ETHER, HYDROGENATED POLYDECENE, PEG-5 GLYCERYL STEARATE, ISODODECANE, SILICA, PHENYL TRIMETHICONE, TREHALOSE, PHENOXYETHANOL, TOCOPHEROL, BUTYROSPERMUM PARKII (SHEA) BUTTER, MACADAMIA TERNIFOLIA SEED OIL, ALEURITES MOLUCCANUS SEED OIL, RHUS VERNICIFLUA PEEL WAX, TAMARINDUS INDICA SEED GUM, SACCHARIDE ISOMERATE, PENTYLENE GLYCOL, ISOSTEARIC ACID, GLYCERYL STEARATE SE, POLYSILICONE-11, BEHENYL ALCOHOL, BEHENIC ACID, STEARIC ACID, BATYL ALCOHOL, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, PEG-30 PHYTOSTEROL, DISODIUM EDTA, SODIUM METAPHOSPHATE, CARBOMER, POLYACRYLATE CROSSPOLYMER-6, POTASSIUM HYDROXIDE, BHT, SODIUM CITRATE, CITRIC ACID, T-BUTYL ALCOHOL. MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES.
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0N1 - Petal
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 0W1 - Pearl
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1C0 - Cameo
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1N2 - Vanille
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1W1 - Porcelain
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2C1 - Blush
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2N1 - Nude
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2W1 - Natural
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3C1 - Fawn
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3N1 - Sand
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3W1 - Bisque
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4C1 - Almond
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4N1 - Wheat
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4W1 - Tawny
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5C1 - Nutmeg
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5N1 - Walnut
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 5W1 - Tan
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6C1 - Cacao
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6W1 - Ganache
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 6N1 - Mocha
-
INGREDIENTS AND APPEARANCE
LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN Â 0N1 PETAL
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-803 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-803-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-803-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  0W1 PEARL
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-804 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-804-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-804-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  1C0 CAMEO
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-805 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-805-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-805-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  1N2 VANILLE
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-806 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-806-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-806-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  1W1 PORCELAIN
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-807 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-807-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-807-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  2C1 BLUSH
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-808 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-808-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-808-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  2N1 NUDE
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-809 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-809-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-809-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  2W1 NATURAL
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-810 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-810-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-810-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  3C1 FAWN
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-811 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-811-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-811-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  3N1 SAND
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-812 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-812-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-812-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  3W1 BISQUE
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-813 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-813-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-813-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  4C1 ALMOND
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-814 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-814-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-814-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  4N1 WHEAT
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-815 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-815-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-815-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  4W1 TAWNY
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-816 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-816-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-816-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  5C1 NUTMEG
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-817 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-817-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-817-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  5N1 WALNUT
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-818 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-818-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-818-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  5W1 TAN
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-819 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-819-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-819-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  6C1 CACAO
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-820 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-820-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-820-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  6W1 GANACHE
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-821 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-821-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-821-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 LAURA MERCIER TINTED MOISTURIZER NATURAL SKIN PERFECTOR BROAD SPECTRUM SPF 30 SUNSCREEN  6N1 MOCHA
avobenzone, octinoxate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-822 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.25 g  in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.745 g  in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g  in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.5 g  in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  GLYCERIN (UNII: PDC6A3C0OX)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  DIMETHICONE (UNII: 92RU3N3Y1O)  PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)  ISODODECANE (UNII: A8289P68Y2)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  TREHALOSE (UNII: B8WCK70T7I)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  SHEA BUTTER (UNII: K49155WL9Y)  MACADAMIA OIL (UNII: 515610SU8C)  KUKUI NUT OIL (UNII: TP11QR7B8R)  TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)  SACCHARIDE ISOMERATE (UNII: W8K377W98I)  PENTYLENE GLYCOL (UNII: 50C1307PZG)  ISOSTEARIC ACID (UNII: X33R8U0062)  GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  DOCOSANOL (UNII: 9G1OE216XY)  BEHENIC ACID (UNII: H390488X0A)  STEARIC ACID (UNII: 4ELV7Z65AP)  BATILOL (UNII: 39YR661C4U)  EDETATE DISODIUM (UNII: 7FLD91C86K)  SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  FERROSOFERRIC OXIDE (UNII: XM0M87F357)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-822-60 1 in 1 CARTON 11/30/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:58411-822-61 1 in 1 CARTON 11/30/2021 2 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/30/2021 Labeler - Laura Mercier Cosmetics (193691821)
