Label: THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20- octinoxate and titanium dioxide liquid
- NDC Code(s): 65966-018-01, 65966-018-02
- Packager: MAX HUBER RESEARCH LAB INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 30, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
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
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
-
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
-
Inactive Ingredients
DECLUSTERED WATER (-)\AQUA\EAU DE-STRUCTUREE (-) • DECLUSTERED WATER (+)\AQUA\EAU DE-STRUCTUREE (+) • CYCLOPENTASILOXANE • ISODODECANE • DIMETHICONE • PHENYL TRIMETHICONE • BUTYLENE GLYCOL • POLYMETHYL METHACRYLATE • POLYSILICONE-11 • COCO-CAPRYLATE/CAPRATE • PEG/PPG-18/18 DIMETHICONE • OCTYLDODECYL NEOPENTANOATE • SILICA • ALGAE (SEAWEED) EXTRACT • SESAMUM INDICUM (SESAME) SEED OIL • MEDICAGO SATIVA (ALFALFA) SEED POWDER • HELIANTHUS ANNUUS (SUNFLOWER) SEEDCAKE • PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED MEAL • EUCALYPTUS GLOBULUS (EUCALYPTUS) LEAF OIL • SODIUM GLUCONATE • COPPER GLUCONATE • CALCIUM GLUCONATE • MAGNESIUM GLUCONATE • ZINC GLUCONATE • TOCOPHERYL SUCCINATE • NIACIN • SESAMUM INDICUM (SESAME) SEED POWDER • POLYGLYCERYL-4 ISOSTEARATE • CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT • CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE • MOLASSES EXTRACT\SACCHARUM OFFICINARUM\EXTRAIT DE MELASSE • CHLORELLA VULGARIS EXTRACT • GELIDIUM CARTILAGINEUM EXTRACT • CORALLINA OFFICINALIS EXTRACT • SACCHAROMYCES LYSATE EXTRACT • SILYBUM MARIANUM (LADY'S THISTLE) EXTRACT • WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT • LAMINARIA SACCHARINA EXTRACT • CODIUM TOMENTOSUM EXTRACT • SUCROSE • GLYCERIN • CHOLESTEROL • ERYNGIUM MARITIMUM EXTRACT • LAMINARIA DIGITATA EXTRACT • GLYCINE SOJA (SOYBEAN) PROTEIN • ACETYL GLUCOSAMINE • CAFFEINE • SORBITOL • SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT • TOURMALINE • ACETYL HEXAPEPTIDE-8 • SODIUM HYALURONATE • HEXYL LAURATE • CETYL PEG/PPG-10/1 DIMETHICONE • DISTEARDIMONIUM HECTORITE • C12-16 ALCOHOLS • MAGNESIUM ALUMINUM SILICATE • TREHALOSE • YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE • DIMETHICONE SILYLATE • PROPYLENE GLYCOL DIETHYLHEXANOATE • YEAST POLYSACCHARIDES • CAPRYLYL GLYCOL • TRIETHYL CITRATE • TETRAHEXYLDECYL ASCORBATE • STEARIC ACID • PALMITIC ACID • HYDROGENATED LECITHIN • METHICONE • PROPYLENE GLYCOL DICAPRATE • TOCOPHERYL LINOLEATE/OLEATE • SODIUM CHLORIDE • ALUMINUM HYDROXIDE • HEXYLENE GLYCOL • TRIETHOXYCAPRYLYLSILANE • FRAGRANCE (PARFUM) • ALCOHOL DENAT. • DISODIUM EDTA • BHT • PHENOXYETHANOL • [+/- MICA • TITANIUM DIOXIDE (CI 77891) • IRON OXIDES (CI 77492) • IRON OXIDES (CI 77491) • IRON OXIDES (CI 77499)] <ILN42899>
- Other information
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65966-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 19 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) NORI (UNII: 477TV3P5UX) SESAME OIL (UNII: QX10HYY4QV) ALFALFA SEED (UNII: 67PHZ58858) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) ALMOND (UNII: 3Z252A2K9G) EUCALYPTUS OIL (UNII: 2R04ONI662) SODIUM GLUCONATE (UNII: R6Q3791S76) COPPER GLUCONATE (UNII: RV823G6G67) CALCIUM GLUCONATE (UNII: SQE6VB453K) MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) ZINC SUCCINATE (UNII: IY01B595GR) .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) NIACIN (UNII: 2679MF687A) SESAME SEED (UNII: 7Y1255HVXR) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) LIME PEEL (UNII: 544EQK5Q0W) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) CUCUMBER (UNII: YY7C30VXJT) HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q) MOLASSES (UNII: LSU3YX0KZO) CHLORELLA VULGARIS (UNII: RYQ4R60M02) PLOCAMIUM CARTILAGINEUM (UNII: 37LBZ0E1UE) CORALLINA OFFICINALIS (UNII: 4004498D06) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) MILK THISTLE (UNII: U946SH95EE) WHEY (UNII: 8617Z5FMF6) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) CODIUM TOMENTOSUM (UNII: B8B45BRU87) SUCROSE (UNII: C151H8M554) GLYCERIN (UNII: PDC6A3C0OX) CHOLESTEROL (UNII: 97C5T2UQ7J) LAMINARIA DIGITATA (UNII: 15E7C67EE8) SOY PROTEIN (UNII: R44IWB3RN5) N-ACETYLGLUCOSAMINE (UNII: V956696549) CAFFEINE (UNII: 3G6A5W338E) SORBITOL (UNII: 506T60A25R) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HEXYL LAURATE (UNII: 4CG9F9W01Q) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) C12-16 ALCOHOLS (UNII: S4827SZE3L) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) TREHALOSE (UNII: B8WCK70T7I) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITIC ACID (UNII: 2V16EO95H1) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) METHICONE (20 CST) (UNII: 6777U11MKT) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALCOHOL (UNII: 3K9958V90M) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65966-018-01 1 in 1 CARTON 03/01/2016 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:65966-018-02 1 mL in 1 PACKET; Type 0: Not a Combination Product 03/02/2022 10/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/01/2016 Labeler - MAX HUBER RESEARCH LAB INC (926708694) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(65966-018) , pack(65966-018) , label(65966-018)
