Label: MINERALIZE SATIN FOUNDATION SPF 15 FOUNDATION- octinoxate liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 40046-0042-1, 40046-0042-2 - 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 May 18, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER [] BUTYLENE GLYCOL [] TRIETHYLHEXANOIN [] SQUALANE [] PROPYLENE GLYCOL STEARATE [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] STEARIC ACID [] GLYCERIN [] KAOLIN [] BETA VULGARIS (BEET) ROOT EXTRACT [] HABERLEA RHODOPENSIS LEAF EXTRACT [] TAMARINDUS INDICA SEED GUM [] YEAST EXTRACT [] MAGNESIUM CHLORIDE [] SODIUM CHLORIDE [] ZINC CHLORIDE [] POTASSIUM CHLORIDE [] LYSINE [] TOCOPHEROL [] PANTHENOL [] POLYSORBATE 20 [] LECITHIN [] TROMETHAMINE [] XANTHAN GUM [] ASCORBYL PALMITATE [] RETINYL PALMITATE [] CAPRYLYL GLYCOL [] SIMETHICONE [] CETYL ALCOHOL [] HYDROGENATED LECITHIN [] MAGNESIUM ALUMINUM SILICATE [] ISOSTEARIC ACID [] HEXYLENE GLYCOL [] PENTYLENE GLYCOL [] DISODIUM EDTA [] POTASSIUM SORBATE [] PHENOXYETHANOL [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]
- WARNINGS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MINERALIZE SATIN FOUNDATION SPF 15 FOUNDATION
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SQUALANE (UNII: GW89575KF9) ISOSTEARIC ACID (UNII: X33R8U0062) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) STEARIC ACID (UNII: 4ELV7Z65AP) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BEET (UNII: N487KM8COK) YEAST (UNII: 3NY3SM6B8U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) SODIUM CHLORIDE (UNII: 451W47IQ8X) ZINC CHLORIDE (UNII: 86Q357L16B) POTASSIUM CHLORIDE (UNII: 660YQ98I10) LYSINE (UNII: K3Z4F929H6) ALPHA-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) PANTHENOL (UNII: WV9CM0O67Z) POLYSORBATE 20 (UNII: 7T1F30V5YH) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TROMETHAMINE (UNII: 023C2WHX2V) XANTHAN GUM (UNII: TTV12P4NEE) ASCORBYL PALMITATE (UNII: QN83US2B0N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 2-OCTANOL (UNII: 66B0DD5E40) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PENTYLENE GLYCOL (UNII: 50C1307PZG) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0042-1 1 in 1 CARTON 1 NDC:40046-0042-2 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2006 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 MANA COSMETICS INC 078870292 manufacture