FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45- ensulizole, octinoxate, octisalate, and zinc oxide liquid

FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45 by

Drug Labeling and Warnings

FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Ensulizole 2.7%	Sunscreen
Octinoxate 6.7%	Sunscreen
Octisalate 4.5%	Sunscreen
Zinc Oxide 3.8%	Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 35 ml Tube Carton

ESTĒE LAUDER

Futurist
Hydra Rescue
Moisturizing Makeup
Broad Spectrum
SPF 45

1.2 FL. OZ. LIQ.
35ml ｅ

INGREDIENTS AND APPEARANCE

FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45 
ensulizole, octinoxate, octisalate, and zinc oxide liquid

Product 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	0.0324 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0804 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.054 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0456 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
CUCUMBER (UNII: YY7C30VXJT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CHIA SEED (UNII: NU0OLX06F8)
HYLOCEREUS 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)
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)
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)

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 NOT FINAL	part352	10/04/2019

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-058) , REPACK(11559-058)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-058)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-058)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-058)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-058)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-058) , REPACK(11559-058)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-058) , REPACK(11559-058)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-058)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-058)