Label: LAURA MERCIER TINTED MOISTURIZER - ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN - BRONZE RADIANCE- avobenzone, octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 65342-1394-0 - Packager: Gurwitch Products, L.L.C.
- 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 July 14, 2015
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- Drug Facts
- Active Ingredient
- Uses
- 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
- 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
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Inactive ingredients
water, dimethicone, cetearyl alcohol, hydrogenated polyisobutene, xylitylglucoside, PEG-40 castor oil, polyglyceryl-4 isostearate, cyclopentasiloxane, potassium cetyl phosphate, hexyl laurate, anhydroxylitol, mica, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethicone, xylitol, polysorbate 60, phenoxyethanol, butylene glycol, tribhenin, 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 glcyrrhizate, may contain: titanium dioxide, iron oixides, copper powder.
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INGREDIENTS AND APPEARANCE
LAURA MERCIER TINTED MOISTURIZER - ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN - BRONZE RADIANCE
avobenzone, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65342-1394 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HEXYL LAURATE (UNII: 4CG9F9W01Q) ANHYDROXYLITOL (UNII: 8XWR7NN42F) MICA (UNII: V8A1AW0880) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XYLITOL (UNII: VCQ006KQ1E) POLYSORBATE 60 (UNII: CAL22UVI4M) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALLANTOIN (UNII: 344S277G0Z) GREEN TEA LEAF (UNII: W2ZU1RY8B0) HYDROGENATED OLIVE OIL (UNII: 53839415GI) SHEANUT OIL (UNII: O88E196QRF) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) EDETATE SODIUM (UNII: MP1J8420LU) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SODIUM ASCORBATE (UNII: S033EH8359) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) COPPER (UNII: 789U1901C5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65342-1394-0 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 - Gurwitch Products, L.L.C. (884875246) Establishment Name Address ID/FEI Business Operations Atlantis Laboratories, Inc. 194673984 manufacture(65342-1394) Establishment Name Address ID/FEI Business Operations Beauty Manufacturing Solutions Corp. 783200723 pack(65342-1394)
