Label: PREP AND PRIME FACE PROTECTION SPF 50- zinc oxide, octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0047-1, 40046-0047-2 - Packager: MAKEUP ART 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 September 16, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER\AQUA\EAU [] CYCLOPENTASILOXANE [] BUTYLENE GLYCOL [] PEG-7 DIMETHICONE [] CYCLOHEXASILOXANE [] DIMETHICONE [] PHENYL TRIMETHICONE [] VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER [] METHYL GLUCETH-10 [] GLYCERIN [] DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER [] CAFFEINE [] TOCOPHEROL [] SUCROSE [] STEARYL GLYCYRRHETINATE [] CELLULOSE ACETATE [] METHICONE [] PEG/PPG-19/19 DIMETHICONE [] MAGNESIUM SULFATE [] SILICA DIMETHYL SILYLATE [] SILICA [] SORBIC ACID [] PHENOXYETHANOL [] CHLORPHENESIN
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREP AND PRIME FACE PROTECTION SPF 50
zinc oxide, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0047 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 16.1 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) METHYL GLUCETH-10 (UNII: N0MWT4C7WH) GLYCERIN (UNII: PDC6A3C0OX) CAFFEINE (UNII: 3G6A5W338E) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) SUCROSE (UNII: C151H8M554) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) CELLULOSE ACETATE (UNII: 3J2P07GVB6) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBIC ACID (UNII: X045WJ989B) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0047-1 1 in 1 CARTON 1 NDC:40046-0047-2 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2006 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture Establishment Name Address ID/FEI Business Operations NIPPON SHIKIZAI INC 692572936 manufacture