Label: LAURA MERCIER FLAWLESS SKIN MEGA MOISTURE CREME BROAD SPECTRUM SPF 15 SUNSCREEN FOR NORMAL/DRY SKIN- avobenzone, octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 65342-0945-0 - 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 13, 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, cyclopentasiloxane, dimethicone, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, Emu oil, glycerin, sorbitol, cetearyl alcohol, peg-40 castor oil, tocopheryl acetate, potassium cetyl phosphate, petrolatum, polysorbate 60, urea, sodium hyaluronate, allantoin, sodium ascorbate, phenoxyethanol, methylparaben, tetrasodium EDTA, carbomer, isopropylparaben, isobutylparaben, butylparaben, sodium dehydroacetate, aminomethyl propanol, linalool, propylparaben, acrylates/c10-30 alkyl acrylate crosspolymer.
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INGREDIENTS AND APPEARANCE
LAURA MERCIER FLAWLESS SKIN MEGA MOISTURE CREME BROAD SPECTRUM SPF 15 SUNSCREEN FOR NORMAL/DRY SKIN
avobenzone, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65342-0945 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 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) EMU OIL (UNII: 344821WD61) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 60 (UNII: CAL22UVI4M) UREA (UNII: 8W8T17847W) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALLANTOIN (UNII: 344S277G0Z) SODIUM ASCORBATE (UNII: S033EH8359) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE SODIUM (UNII: MP1J8420LU) ISOPROPYLPARABEN (UNII: A6EOX47QK0) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) BUTYLPARABEN (UNII: 3QPI1U3FV8) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) LINALOOL, (+/-)- (UNII: D81QY6I88E) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65342-0945-0 50 g in 1 JAR; 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(65342-0945) Establishment Name Address ID/FEI Business Operations Beauty Manufacturing Solutions Corp. 783200723 pack(65342-0945)
