Label: 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
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NDC Code(s):
58411-369-60,
58411-370-60,
58411-371-60,
58411-372-60, view more58411-373-60
- Packager: Laura Mercier Cosmetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 29, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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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
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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
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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
- For sunscreen use:
- Other information
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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?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Bronze Radiance
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Golden Radiance
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Warm Radiance
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Natural Radiance
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - Bare Radiance
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INGREDIENTS AND APPEARANCE
LAURA MERCIER TINTED MOISTURIZER ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN 5N1 BRONZE RADIANCE
avobenzone and octinoxate creamProduct 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 creamProduct 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 creamProduct 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 creamProduct 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 creamProduct 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)