LAURA MERCIER TINTED MOISTURIZER ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 5N1 BRONZE RADIANCE- avobenzone and octinoxate cream LAURA MERCIER TINTED MOISTURIZER ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 4N1 GOLDEN RADIANCE- avobenzone and octinoxate cream LAURA MERCIER TINTED MOISTURIZER ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 3N1 WARM RADIANCE- avobenzone and octinoxate cream LAURA MERCIER TINTED MOISTURIZER ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 2N1 NATURAL RADIANCE- avobenzone and octinoxate cream LAURA MERCIER TINTED MOISTURIZER ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 1N1 BARE RADIANCE- avobenzone and octinoxate cream

Laura Mercier Tinted Moisturizer by

Drug Labeling and Warnings

Laura Mercier Tinted Moisturizer by is a Otc medication manufactured, distributed, or labeled by Laura Mercier Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (2.0%), Octinoxate (7.5%)

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If 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 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
• Children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

Water, Dimethicone, Mica, Cetearyl Alcohol, Hydrogenated Polyisobutene, Xylitylglucoside, PEG-40 Castor Oil, Polyglyceryl-4 Isostearate, Cyclopentasiloxane, Potassium Cetyl Phosphate, Hexyl Laurate, Anhydroxylitol, Tocopheryl Acetate, Cetyl PEG/PPG-10/1 Dimethicone, Xylitol, Polysorbate 60, Phenoxyethanol, Butylene Glycol, Tribehenin, Sodium Dehydroacetate, Sodium Hyaluronate, Allantoin, Camellia Sinensis Leaf Extract, Copper Gluconate, Carbomer, Hydrogenated Olive Oil, Butyrospermum Parkii (Shea) Butter, Aminomethyl Propanol, Tetrasodium EDTA, Magnesium Aluminum Silicate, Sodium Ascorbate, Dipotassium Glycyrrhizate, Tin Oxide. May Contain: Titanium Dioxide, Iron Oxides.

Questions or comments?

Call 1-888-637-2437, M – F 9am – 5pm CST.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Bronze Radiance

laura mercier

TINTED MOISTURIZER
ILLUMINATING
BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Golden Radiance

laura mercier

TINTED MOISTURIZER
ILLUMINATING
BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Warm Radiance

laura mercier

TINTED MOISTURIZER
ILLUMINATING
BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Natural Radiance

laura mercier

TINTED MOISTURIZER
ILLUMINATING
BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Bare Radiance

laura mercier

TINTED MOISTURIZER
ILLUMINATING
BROAD SPECTRUM
SPF 20 SUNSCREEN

50 mL / 1.7 FL. OZ. LIQ. US

INGREDIENTS AND APPEARANCE

LAURA MERCIER TINTED MOISTURIZER   ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 5N1 BRONZE RADIANCE
avobenzone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-369
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1000 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3750 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XYLITOL (UNII: VCQ006KQ1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COPPER GLUCONATE (UNII: RV823G6G67)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
SHEA BUTTER (UNII: K49155WL9Y)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
EDETATE SODIUM (UNII: MP1J8420LU)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM ASCORBATE (UNII: S033EH8359)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-369-60	1 in 1 CARTON	11/29/2010
1		50 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 NOT FINAL	part352	11/29/2010

LAURA MERCIER TINTED MOISTURIZER   ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 4N1 GOLDEN RADIANCE
avobenzone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1000 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3750 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XYLITOL (UNII: VCQ006KQ1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COPPER GLUCONATE (UNII: RV823G6G67)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
SHEA BUTTER (UNII: K49155WL9Y)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
EDETATE SODIUM (UNII: MP1J8420LU)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM ASCORBATE (UNII: S033EH8359)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-370-60	1 in 1 CARTON	11/29/2010
1		50 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 NOT FINAL	part352	11/29/2010

LAURA MERCIER TINTED MOISTURIZER   ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 3N1 WARM RADIANCE
avobenzone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-371
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1000 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3750 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XYLITOL (UNII: VCQ006KQ1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COPPER GLUCONATE (UNII: RV823G6G67)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
SHEA BUTTER (UNII: K49155WL9Y)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
EDETATE SODIUM (UNII: MP1J8420LU)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM ASCORBATE (UNII: S033EH8359)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-371-60	1 in 1 CARTON	11/29/2010
1		50 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 NOT FINAL	part352	11/29/2010

LAURA MERCIER TINTED MOISTURIZER   ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 2N1 NATURAL RADIANCE
avobenzone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-372
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1000 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3750 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XYLITOL (UNII: VCQ006KQ1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COPPER GLUCONATE (UNII: RV823G6G67)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
SHEA BUTTER (UNII: K49155WL9Y)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
EDETATE SODIUM (UNII: MP1J8420LU)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM ASCORBATE (UNII: S033EH8359)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-372-60	1 in 1 CARTON	07/10/2015
1		50 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 NOT FINAL	part352	07/10/2015

LAURA MERCIER TINTED MOISTURIZER   ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 1N1 BARE RADIANCE
avobenzone and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-373
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1000 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3750 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XYLITOL (UNII: VCQ006KQ1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COPPER GLUCONATE (UNII: RV823G6G67)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
SHEA BUTTER (UNII: K49155WL9Y)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
EDETATE SODIUM (UNII: MP1J8420LU)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM ASCORBATE (UNII: S033EH8359)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-373-60	1 in 1 CARTON	11/29/2010
1		50 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 NOT FINAL	part352	11/29/2010

Labeler - Laura Mercier Cosmetics (193691821)