Label: FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45- ensulizole, octinoxate, octisalate, and zinc oxide liquid
- NDC Code(s): 11559-058-01
- Packager: ESTEE LAUDER INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 13, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- 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
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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
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Inactive ingredients
water\aqua\eau • dimethicone • phenyl trimethicone • butylene glycol • glycerin • polymethylsilsesquioxane • lauryl peg-9 polydimethylsiloxyethyl dimethicone • hdi/ppg/polycaprolactone crosspolymer • trimethylsiloxysilicate/dimethiconol crosspolymer • tromethamine • polysilicone-11 • hexyl laurate • cetyl peg/ppg-10/1 dimethicone • lactobacillus ferment • cucumis sativus (cucumber) fruit extract • sodium hyaluronate • salvia hispanica seed extract • hylocereus undatus fruit extract • helianthus annuus (sunflower) seedcake • algae extract • euterpe oleracea fruit oil • carapa guaianensis seed oil • caffeine • jojoba esters • tremella fuciformis sporocarp extract • camelina sativa seed oil • sapindus mukorossi fruit extract • caesalpinia spinosa gum • copaifera officinalis (balsam copaiba) resin • caprylic/capric triglyceride • propylene glycol dicaprate • acetyl glucosamine • tocopheryl acetate • acetyl hexapeptide-8 • lecithin • trehalose • disteardimonium hectorite • hydroxyethyl urea • neopentyl glycol diheptanoate • dimethicone/divinyldimethicone silsesquioxane crosspolymer • hydrogenated coco-glycerides • phospholipids • trimethylsiloxysilicate • polyhydroxystearic acid • polyglyceryl-4 isostearate • glyceryl stearate • triethoxycaprylylsilane • triethyl citrate • laureth-7 • linoleic acid • methicone • stearyl alcohol • cetearyl alcohol • ammonium polyacryloyldimethyl taurate • silica • hordeum vulgare (barley) extract\extrait d'orge • tocopherol • palmitic acid • phytosteryl canola glycerides • stearic acid • oleic acid • sodium chloride • polysorbate 80 • polysorbate 20 • behenyl alcohol • triolein • betaine • fragrance (parfum) • disodium edta • bht • phenoxyethanol • sodium dehydroacetate • potassium sorbate • [+/- mica • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • titanium dioxide (ci 77891)] <iln47153>
- Other information
- PRINCIPAL DISPLAY PANEL - 35 ml Tube Carton
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INGREDIENTS AND APPEARANCE
FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45
ensulizole, octinoxate, octisalate, and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11559-058 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 27 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 67 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 38 mg in 1 mL Inactive Ingredients Ingredient Name Strength HYALURONATE SODIUM (UNII: YSE9PPT4TH) CHIA SEED (UNII: NU0OLX06F8) SELENICEREUS UNDATUS FRUIT (UNII: WUG58TD53X) HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC) ACAI OIL (UNII: Z0W6766A2W) CARAPA GUIANENSIS SEED OIL (UNII: Y82418EH2I) CAFFEINE (UNII: 3G6A5W338E) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) CAMELINA SATIVA SEED OIL (UNII: 12824X01L0) SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) N-ACETYLGLUCOSAMINE (UNII: V956696549) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) TREHALOSE (UNII: B8WCK70T7I) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) LAURETH-7 (UNII: Z95S6G8201) LINOLEIC ACID (UNII: 9KJL21T0QJ) METHICONE (20 CST) (UNII: 6777U11MKT) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYSORBATE 20 (UNII: 7T1F30V5YH) DOCOSANOL (UNII: 9G1OE216XY) GLYCERYL TRIOLEATE (UNII: O05EC62663) BETAINE (UNII: 3SCV180C9W) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BARLEY (UNII: 5PWM7YLI7R) TOCOPHEROL (UNII: R0ZB2556P8) PALMITIC ACID (UNII: 2V16EO95H1) STEARIC ACID (UNII: 4ELV7Z65AP) OLEIC ACID (UNII: 2UMI9U37CP) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) TROMETHAMINE (UNII: 023C2WHX2V) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) HEXYL LAURATE (UNII: 4CG9F9W01Q) LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE) CUCUMBER (UNII: YY7C30VXJT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11559-058-01 1 in 1 CARTON 10/04/2019 1 35 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 Drug M020 10/04/2019 Labeler - ESTEE LAUDER INC (005914387) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 manufacture(11559-058) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(11559-058) , label(11559-058) Establishment Name Address ID/FEI Business Operations LE PAPILLON, LTD. 040070823 label(11559-058) , pack(11559-058)