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
- Marketing Status: OTC monograph 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 August 31, 2023
If you are a consumer or patient please visit this version.
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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 final 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)
